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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Hemodynamic instability (4868)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 weight 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
Clinical rationale: a 75-year-old male underwent impella cp (b)(6) placement on (b)(6) 2026 at 14:30 for pre operative hemodynamic support.The device was inserted percutaneously via the femoral artery in the catheterization lab, after which the patient was immediately taken to the operating room for cabg.Approximately three hours after impella placement, at 08:00 on (b)(6) 2026, the patient developed lower limb ischemia, characterized by peripheral cold sensation.The ischemia was diagnosed during/after sheath insertion and attributed to impella use, with the patient¿s vessel diameter reported as <2.5/4 mm.The impella cp was removed at 19:00 on (b)(6) 2026, and the ischemia resolved following device explant.Due to ongoing clinical needs, an impella 5.5 was surgically implanted via the right axillary/subclavian artery on (b)(6) 2026 at 12:00 am, product return is not expected for the impella cp, and no device damage was noted.The patient¿s outcome is pending as he is currently on support.The impella cp will be conservatively reported for hemodynamic instability due to temporary hemodynamic support interruption during the exchange however the exchange was performed with no consequence to the patient and support was resumed without any known adverse events.
Additional Manufacturer Narrative
B3 and d6b was erroneously entered on the initial manufacturer device report.
Additional Manufacturer Narrative
Corrected information was provided in d1 (brand name).Upon review, it was identified that the section d brand name has now been updated.Corrected information was provided in d3, g1 (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.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the injury was not 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): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24581028
• Report Number: 1220648-2026-05150
• Device Sequence Number: 9233763
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)261231(10)2026632940
• 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: 2026632940
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 03/07/2026; 04/23/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/18/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian