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

Catalog Number	0052-3005
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A 75-year-old female patient with postcardiotomy cardiogenic shock (pccs) underwent attempted impella support.Based on the limited procedural information available, it is assumed that the patient was already receiving ecmo support at the time of the attempt.During advancement of the guidewire toward the left ventricle, the aortic valve was not opening, which prevented successful wire passage and device insertion.As a result, impella support could not be initiated.
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.
Additional Manufacturer Narrative
D3 (manufacturer fax) & e4 (reporter also sent report to fda?) has been omitted from the initial medwatch.The cause of the hemodynamic instability was unable to be determined as insufficient clinical details were provided.The cause of the failure to advance was determined to be patient condition as the patient had difficult anatomy as the aortic valve was not opening preventing successful delivery of impella.

• 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): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24658908
• Report Number: 1220648-2026-05764
• Device Sequence Number: 5032371
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(11)241024(10)8854080
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3005
• Device Lot Number: 8854080
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/22/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White