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

Catalog Number	0048-0045
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A4 weight 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
Clinical narrative: an impella cp device was inserted via the right femoral artery in a 78-year-old male patient for the indication of acute myocardial infarction complicated by cardiogenic shock (ami/cgs).The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was consistent with society for cardiovascular angiography and interventions (scai) stage b cardiogenic shock.It was noted that the patient arrived in cardiac arrest.It was reported that the first impella cp pump was not purging correctly.In response to the reported issue, the physician requested placement of a second impella cp device, and the initial device was removed and replaced.The patient remained critically ill despite ongoing mechanical circulatory support and subsequently expired while supported on the second impella cp device.No adverse events were reported with the second impella cp.The death is conservatively being reported on the first impella cp device due to the temporal association with the reported purge issue requiring device replacement.Based on the available clinical information, the outcome is most likely attributable to the patient's underlying acute myocardial infarction, cardiogenic shock, and presentation in cardiac arrest.

• 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 (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25442818
• Report Number: 1220648-2026-08617
• Device Sequence Number: 14913034
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270630(10)2026716047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2026716047
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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: 78 YR
• Patient Sex: Male
• Patient Race: White