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

Catalog Number	0048-0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	03/23/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative: an impella cp device was inserted via the left femoral artery in a 58-year-old male patient presenting with ami/cgs, scai shock stage e.The patient¿s comorbidities were unknown.A head ct scan demonstrated a massive ischemic stroke.A transesophageal echocardiogram (tee) obtained on the same day revealed a thrombus in the right atrium.According to paramedics, the patient had ¿fluctuating neurological responses¿ prior to arrival to the intensive care unit, indicating neurologic compromise before impella support.Based on the available information, the clinical team considered the neurologic findings unlikely to be related to the impella device.Care was withdrawn, and the patient expired.The reported stroke may be attributed to the patient¿s underlying critical illness and a pre-existing neurologic event prior to impella implantation.The reported thrombosis is consistent with thrombus formation in the setting of cardiogenic shock and critical illness.The device will be conservatively reported for death; however, the death is most likely attributable to the severity of the underlying cardiogenic shock and neurologic injury.
Additional Manufacturer Narrative
The exact date of death is unknown but has been captured as the date of explant.If additional information becomes known, a supplemental report will be submitted.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
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in e3 (initial reporter occupation).Upon review, it was identified that it was inadvertently submitted in error in the initial report.Corrected information was provided in e4 (reporter also sent report to fda?).Upon review, it was identified that it was inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.
Additional Manufacturer Narrative
The returned device has been received, and evaluation/analysis is currently in progress.Accordingly, section d9 has been updated to reflect the device receipt date.Section h6 (investigation type, findings, and conclusion) has also been updated to align with this information.Note: d4 serial number was noted as updated/corrected accordingly.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
D4.Primary udi number corrected.H6: investigation: type, findings, conclusion codes and h6 component codes were updated accordingly based on the completed investigation.The device was returned for investigation.The root cause of the injury was unable to be determined due to insufficient clinical details.

• 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): AACHEN
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24741094
• Report Number: 1220648-2026-06156
• Device Sequence Number: 9049272
• Product Code: OZD
• UDI-Device Identifier: 04260113630280
• UDI-Public: (01)04260113630280(17)270831(10)2026814878
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: 0048-0014
• Device Lot Number: 2026814878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2025
• 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; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male