MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	1000080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	03/21/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
A4 is unknown.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.
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 89-year-old female patient presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in scai stage e shock, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support for a protected percutaneous coronary intervention (pci).While the patient was in the intensive care unit (icu), there was a loss of impella in aorta (ao) and left ventricle (lv) signals on the automated impella controller (aic).Flow were at 3.5l/min, the motor current was pulsatile, and the dial was still turning on the aic.To troubleshoot, the nurse pushed the white connector into the aic and waveform signals returned.No further issues were noted.There was no noted interruption of flow or support for the patient.The following day after impella support, the family withdrew care due to the patient requiring continuous renal replacement therapy (crrt), and the patient expired on support.The impella functioned at p-6 at 2.9l/min as intended.Renal failure is a known adverse event associated with impella's mechanical support.The impella is conservatively being reported for death; however, is unlikely to have contributed to the patient's death, which was most likely due to the clinical condition of a critically ill patient in acute myocardial infarction and cardiogenic shock, complicated by stage e shock.
Additional Manufacturer Narrative
The investigation was completed.Investigation summary: renal failure/ppae: the cause of the injury was not determined due to insufficient clinical details.
Additional Manufacturer Narrative
Updated information: d4 catalog number updated.D6a/d6b implant and explant date added.H6 component code updated to g07003 in follow up #1 but was not noted in h11.

• 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 ; 7814934967
• MDR Report Key: 24740985
• Report Number: 1220648-2026-06149
• Device Sequence Number: 8731505
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2026768714
• 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: 03/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 04/29/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/22/2026; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White