MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	1000100
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	09/13/2026
Type of Reportable Event	Death
Event or Problem Description
An impella 5.5 with smartassist device was inserted into the left axillary/subclavian artery in a 65-year-old male patient presenting with acute decompensated cardiomyopathy.Prior to impella support, the patient was classified as society for cardiovascular angiography & interventions (scai) stage d shock, indicating deterioration despite escalation of therapy.The patient was supported with an intra-aortic balloon pump (iabp), multiple inotropes, vasopressors, and ventilatory support.The patient's medical history was significant for coronary artery disease (cad) and cardiac arrest requiring cardiopulmonary resuscitation (cpr).On day 2 of support, while the patient was in the intensive care unit (icu), the patient developed persistent ventricular tachycardia (vt), which was reported by the clinical team to be related to the impella 5.5.No additional information regarding device position, troubleshooting measures, or corrective interventions was reported.Subsequently, the medical team elected to withdraw care and the patient expired.Throughout support, the impella 5.5 functioned at performance level p-8 with reported flows of approximately 5.1 l/min utilizing a d5w heparin purge solution.Persistent ventricular tachycardia (vt) was reported during impella 5.5 support and was considered by the clinical team to be device related.While the patient's underlying cardiomyopathy, cardiogenic shock, coronary artery disease, and prior cardiac arrest likely contributed to an increased arrhythmic risk, the reported association between the impella 5.5 and the vt, combined with the subsequent withdrawal of care, precludes definitive exclusion of the device as a contributing factor to the patient's death.Clinical narrative updated 2026-9-25: since the original report, additional clinical information has been received.The patient was noted to have a small left ventricular cavity with the interventricular septum displaced upward.During support, the patient experienced multiple shocks from an implantable cardioverter-defibrillator (icd) for management of recurrent arrhythmias.Following these icd discharges, appropriate impella positioning could not be achieved prior to the decision to withdraw care.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc or its employees that the report constitutes an admission that the product, abiomed inc, or its employees, caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: Impella
• Common Device Name: Temporary Non-Roller Type Left Heart Support Blood Pump
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50923553
• Report Number: 1220648-2026-13090
• Device Sequence Number: 5778832
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• UDI-Public: (01)00813502012828(17)280531(10)2027929602
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000100
• Device Lot Number: 2027929602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Implantable Cardioverter-Defibrillator.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 193 LB
• Patient Race: White