Abiomed Responds to MedSun Report on Two Impella Pumps

Editor's note: This story has been updated from the original story to include comments from Abiomed. A report published through FDA's medical product safety network (MedSun) database describes two issues that involve Abiomed's Impella heart pumps. However, the company told MD+DI that the information in the MedSun report is inaccurate. According to the report, which is located here on FDA's website, one Impella pump reportedly had an unknown "material" inside the pump, causing it to have flows "less than expected," and another pump's housing/outlet cage and impeller were somehow crushed and the device did not start. Abiomed claims that the pumps did not malfunction. "The first pump worked exactly as it was supposed to – a clot was detected in the patient’s bloodstream and a safety mechanism triggered, shutting down the pump, so the clot did not go to the patient’s brain.  The second pump was damaged during the insertion process," said Tom Langford, director of communications and public relations at Abiomed. MedSun is an adverse event reporting program launched in 2002 by FDA's Center for Devices and Radiological Health (CDRH). The way the program works is participants use an Internet-based system that is designed to serve as an easy and secure way to report adverse medical device events. The agency says the primary goal for MedSun is t...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news

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Conclusion Despite initial stabilisation with combined MCS in patients with rCS-complicated influenza-related myocarditis, the detrimental course of shock could not be stopped and all patients died. Influenza virus infection potentially critically affects other organs besides the heart, leading to irreversible end-organ damage that MCS cannot compensate for and, therefore, results in a devastating outcome.
Source: European Respiratory Journal - Category: Respiratory Medicine Authors: Tags: Lung cancer Original Articles: Critical care Source Type: research
Abstract A number of devices can now provide mechanical circulatory support (MCS) to patients with acute cardiogenic shock (CS) and chronic end-stage heart failure (HF). Women differ from men in pathophysiology and natural history of CS and HF, and are usually sicker at admission. Current evidence suggests that women benefit as much as men, if not more, from both temporary and durable MCS for appropriate indications. Yet, women have been under-represented in clinical trials of MCS devices. Limited evidence suggests that women benefit more from temporary MCS in CS associated with acute myocardial infarction. Howeve...
Source: Journal of Cardiology - Category: Cardiology Authors: Tags: J Cardiol Source Type: research
Source: Dr. Smith's ECG Blog - Category: Cardiology Authors: Source Type: blogs
We report the first U.S. experience of the recently approved micro-axial surgical heart pump for the treatment of ongoing cardiogenic shock following acute myocardial infarction (AMICGS), postcardiotomy cardiogenic shock (PCCS), cardiomyopathy including myocarditis, high-risk percutaneous coronary intervention (HRPCI), and coronary artery bypass surgery (HRCABG). Demographic, procedural, hemodynamic, and outcome data were obtained from the manufacturer’s quality database of all Impella 5.5 implants at three centers. Fifty-five patients underwent an Impella 5.5 implant for cardiomyopathy (45%), AMICGS (29%), PCCS (13%...
Source: ASAIO Journal - Category: Medical Devices Tags: Adult Circulatory Support Source Type: research
CONCLUSIONS: Among inoperable patients with severe MR and cardiogenic shock, percutaneous leaflet repair with MitraClip is associated with acceptable short-term effectiveness. PMID: 32385191 [PubMed - as supplied by publisher]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Abstract Cardiogenic shock (CS) is defined as end-organ hypoperfusion as the consequence of primary myocardial dysfunction. Among the diagnostic criteria are a systolic blood pressure
Source: Wiener Klinische Wochenschrift - Category: General Medicine Authors: Tags: Wien Klin Wochenschr Source Type: research
AbstractAimsThe aim of this study was to determine the incidence, predictors, and short ‐term and long‐term outcomes associated with in‐hospital sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) collectively termed ventricular arrhythmia (VA) in the heart failure (HF) patients.Methods and resultsThe HEart function Assessment Registry Trial in Saudi Arabia (HEARTS registry) is a prospective national registry of patients with chronic HF from18 tertiary care hospitals across Saudi Arabia. Diagnosis of HF was in accordance with American Heart Association/European Society of Cardiology definition cr...
Source: ESC Heart Failure - Category: Cardiology Authors: Tags: Original Research Article Source Type: research
Conclusions. We report the use of IABP in patients with acute chest pain admitted for angiography. Long-term survival is acceptable and discriminating factors were no revascularisation, out-of-hospital cardiac arrest and age. IABP was safe and feasible and the complication rate was low. PMID: 31476881 [PubMed - as supplied by publisher]
Source: Scandinavian Cardiovascular Journal - Category: Cardiology Tags: Scand Cardiovasc J Source Type: research
Fluoropyrimidines are chemotherapeutic agents that confer great benefit to many patients with solid tumors, but their use is often limited by cardiotoxicity. The incidence and precise mechanisms of cardiotoxicity remain uncertain. Clinical presentations of fluoropyrimidine toxicity are varied and include chest pain, myocardial infarction, acute cardiomyopathy, arrhythmia, cardiogenic shock, and sudden cardiac death. Proposed mechanisms include coronary vasospasm, coronary endothelial dysfunction, direct myocardial toxicity, myocarditis, and Takotsubo cardiomyopathy. Therapeutic and prophylactic interventions primarily targ...
Source: Cardiology Clinics - Category: Cardiology Authors: Source Type: research
CONCLUSION: In patients with cardiogenic shock after delivery, early transthoracic echocardiography is a non-invasive tool that can rapidly narrow the differential diagnosis. PMID: 31324480 [PubMed - as supplied by publisher]
Source: Journal of Obstetrics and Gynaecology Canada : JOGC - Category: OBGYN Tags: J Obstet Gynaecol Can Source Type: research
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