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

Catalog Number	1000100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Stroke/CVA (1770); Thromboembolism (2654)
Date of Event	09/07/2026
Type of Reportable Event	Death
Event or Problem Description
Impella 5.5 smartassist (sa) was inserted via right axillary artery surgical access in a 65-year-old male patient presenting with acute myocardial infarction and cardiogenic shock.The patient's comorbidities included coronary artery disease, diabetes mellitus, renal insufficiency, and dialysis dependence.The patient's clinical condition prior to support initiation was society for cardiovascular angiography and interventions (scai) shock stage e, indicating profound cardiogenic shock with hypoperfusion and end-organ dysfunction despite extensive therapeutic interventions.Prior to impella 5.5 support, the patient had received 45 days of prior impella support and extracorporeal membrane oxygenation (ecmo).Additional therapies included inotropes, vasopressors, and respiratory support.The patient was being bridged to heart transplantation while receiving multiple forms of mechanical circulatory support.After 88 days of impella 5.5 smartassist support, the device was explanted.The support duration exceeded the device indication for use.Following explant, the patient remained hospitalized.Five days post explant the patient developed neurological changes and experienced a cardiac arrest.The clinical team suspected an embolic stroke secondary to thrombus migration from the impella 5.5 smartassist graft, resulting in anoxic neurological injury.Following the cardiac arrest, an impella cp smartassist and a new ecmo system were implanted for continued circulatory support.After four days the patient expired.The stroke and subsequent cardiac arrest are considered related to the impella 5.5 procedure as the physician stated that the concern was that clot formation from the graft was a contributing factor.The device is also considered to have contributed to the patient outcome of death as the patient decompensated following the stroke.
Additional Manufacturer Narrative
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: 50914359
• Report Number: 1220648-2026-13403
• Device Sequence Number: 14784904
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000100
• Device Lot Number: 2027816098
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 195 LB
• Patient Race: White