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

Catalog Number	0048-0024-JP
Medical Device Problem Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	05/23/2026
Type of Reportable Event	Serious Injury
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 80-year-old male with acute myocardial infarction complicated by cardiogenic shock underwent impella cp support via right femoral arterial percutaneous access on (b)(6) 2026.On the morning of (b)(6), the patient developed cardiac tamponade, and imaging revealed left ventricular perforation localized between the lateral and posterior walls.Surgical repair was performed.The physician determined that the perforation did not correspond with the infarction site and attributed the event to the impella device, noting that the pump may have initially been positioned slightly toward the posterior wall, closer to the lateral wall, which may have contributed to the perforation.The patient had reported pain between implantation and the time of diagnosis, although the exact timing of the perforation could not be determined.The impella device was subsequently removed on (b)(6) 2026, as it was no longer required.Following surgical repair, the patient recovered, was extubated, and was reported to be stable with plans for discharge from the icu.
Additional Manufacturer Narrative
D6b.Explant date was erroneously entered on the initial manufacturer device report.

• 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: 25360205
• Report Number: 1220648-2026-08338
• Device Sequence Number: 10650460
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)260731(10)2025564982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2025564982
• 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: 05/23/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian