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

Catalog Number	2000171
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
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
A 73-year-old man presented for transcatheter aortic valve replacement.During the procedure, the patient experienced a cardiac arrest, and an impella cp device was placed during active resuscitation.In the intensive care unit, a purge cassette error message was observed.The purge cassette was replaced, after which the device functioned as intended.Despite continued mechanical support, the patient¿s clinical condition deteriorated with recurrent episodes of cardiac arrest and escalating pharmacologic circulatory support requirements.The patient subsequently experienced ventricular fibrillation and expired on september 9.The event is being conservatively reported as a patient death potentially associated with the device; however, based on available information, it is unlikely that the device contributed to the patient¿s death, which is believed to be related to the patient¿s severe underlying clinical condition.This report is regarding the purge cassette.
Additional Manufacturer Narrative
Updated information: d4 catalog number updated.

• 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 EUROPE GMBH; neuenhofer weg 3; aachen ; GM
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25028600
• Report Number: 1220648-2026-07233
• Device Sequence Number: 10133482
• Product Code: DYB
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)00813502012477(17)260331(10)1721527
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 05/18/2026

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 2000171
• Device Lot Number: 1721527
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White