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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/20/2026
Type of Reportable Event	Death
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.
Event or Problem Description
An impella cp device was inserted into the right femoral artery in a 68-year-old male patient with a past medical history of coronary artery bypass graft (cabg) and coronary artery disease (cad), presenting in acute myocardial infarction (ami) and cardiogenic shock (cgs), in scai stage e shock, on an intra-aortic balloon pump (iabp), on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.While the patient was in the intensive care unit (icu), there was bleeding around the impella site and bleeding at the femoral site where the iabp was removed.The following day after impella insertion, the patient expired on support.The impella functioned at p-9 at 3.5l/min as intended.Bleeding is a known risk due to the impella's anticoagulation and purge requirements.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.
Event or Problem Description
Additional information was received: the peel-away sheath was removed, and a repositioning sheath was advanced without issue.Blood products were administered before and after impella cp insertion.
Additional Manufacturer Narrative
B5 clinical narrative updated and h6 codes updated.Section d4 catalog number was corrected.
Additional Manufacturer Narrative
Upon review, it was identified that the manufacturer fax (d3) was inadvertently omitted in error; the complete fax number has now been provided.Corrected information has been provided in d4 serial number.H6 investigation: type, findings, and conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The cause of the access site adverse event was not determined due to insufficient clinical details.

• 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: 24741093
• Report Number: 1220648-2026-06157
• Device Sequence Number: 14764015
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• UDI-Public: (01)00813502012279(17)271130(10)2026812976
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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

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: 2026812976
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 04/04/2026; 05/12/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/07/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White