BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 24592263 · Received March 13, 2026

    Report

    Report Number
    1220648-2026-05184
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    March 4, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D1. THE CAUSE OF THE DELIVERY ISSUE WAS RELATED TO PATIENT CONDITION PER CLINICAL DETAILS OF SEVERE TORTUOSITY AND CALCIFICATION. HYPOTENSION: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS BEING INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 84 YEAR OLD MALE PATIENT WITH KNOWN CORONARY ARTERY DISEASE AND ADMISSION FOR THE PROTECTED PERCUTANEOUS CORONARY INTERVENTION (PCI). UNDERLYING MEDICAL HISTORY WAS NOT SHARED BEYOND PERIPHERAL DISEASE. TO ALLOW FOR THE CP PLACEMENT THE TEAM PERFORMED ANGIOPLASTY AT THE ILIACS. THE PATIENT HAD LITHOTRIPSY AND BILATERAL ILIAC STENTS PLACED. THE TEAM PLACED THE 14FR COOK SHEATH (NOT THE ABIOMED PROVIDED AND APPROVED SHEATH) TO THE FEMORAL BUT, THE CP WAS UNABLE TO BE FULLY INSERTED AND DELIVERED TO THE LEFT VENTRICLE. THE PUMP WAS UNABLE TO DELIVER THROUGH THE ASCENDING AORTA DUE TO SEVERE TORTUOSITY AND CALCIFICATION. THE PATIENT BECAME HYPOTENSIVE AND THE THEY REMOVED THE CP AND OBSERVED A VESSEL PERFORATION AT THE STENT EDGE. THE PATIENT HAD A NEW ENDOGRAFT PLACED TO REMEDY THE PERFORATION. THE CP FAILED TO DELIVER, THOUGH THE PATIENT SURVIVED WITHOUT THE PUMP. THE SEVERE ARTERIAL DISEASE PRECLUDED THE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653733 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027837720 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention