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	Failure to Advance (2524); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional information was received indicating there was no abiomed product inserted before the decision was made to abort the pump delivery.No product was utilized and as such the event is not reportable.No further reports will be submitted.
Event or Problem Description
An impella cp was being inserted via the femoral artery to support the 70 year old male patient admitted in with indication of acute myocardial infarction and cardiogenic shock, presenting in scai stage e shock.The patient's underlying medical history was inclusive of peripheral arterial disease.The ascending aorta was occluded, calcification and tortuousity, as well as aneurysm.The underlying vascular path prevented the successful delivery of the impella to the left ventricle.The advancement of the product was aborted.On the day of the aborted delivery the patient expired.The team in japan did state the patient had failed to recover from the cardiac arrest and the inability to receive treatment were contributing factors to the patient outcome.The device will be conservatively reported for death; however, the death is most likely attributed to the patient's underlying critical clinical condition post cardiac arrest as well as the delivery failure of the cp due to native anatomy.
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.
Additional Manufacturer Narrative
After further information was received, this event was determined not to be a reportable event.

• 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: 25240506
• Report Number: 1220648-2026-08056
• Device Sequence Number: 16085602
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271111(10)2027820887
• 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,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: 0048-0024-JP
• Device Lot Number: 2027820887
• 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: 05/12/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 06/01/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2026
• 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: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian