BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25073137 · Received May 4, 2026

    Report

    Report Number
    1220648-2026-07446
    Event Type
    Death
    Date Received
    May 4, 2026
    Date of Event
    April 13, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A6 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 · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE IS PRODUCT PROBLEM (B1) WAS INADVERTENTLY OMITTED IN ERROR. ADDED D3 MANUFACTURER FAX WAS OMITTED DURING INITIAL REPORT. CORRECTED D4 SERIAL NUMBER. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE POSITIONING ISSUE AND SUBSEQUENT VENTRICLE PERFORATION WAS DETERMINED TO BE USE RELATED AS IT OCCURRED WHEN THE PHYSICIAN ELEVATED THE HEART AS PART OF A PROCEDURE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED B2, B5, H1 AND H6 WERE UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT "THE PT IS CURRENTLY STILL ON SUPPORT AND HAS TRANSFERRED TO MED CITY HEART & SPIN."

    Additional Manufacturer Narrative · 0

    EXPLANT DATE WAS PROVIDED D6B WAS UPDATED.

    Description of Event or Problem · 0

    A 57-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND DIABETES MELLITUS UNDERWENT ELECTIVE PLACEMENT OF AN IMPELLA 5.5 VIA THE RIGHT AXILLARY ARTERY ON (B)(6) 2026 AT 10:00 AM. DURING THE PROCEDURE, THE CARDIOTHORACIC SURGEON REPORTED DIFFICULTY POSITIONING THE AORTIC CROSS-CLAMP WITHOUT CONTACTING THE IMPELLA MOTOR HOUSING. TO FACILITATE CROSS-CLAMP PLACEMENT, THE IMPELLA PUMP WAS POSITIONED DEEPER WITHIN THE LEFT VENTRICLE. AFTER APPLICATION OF THE AORTIC CROSS-CLAMP AND WHILE THE PATIENT WAS ON CARDIOPULMONARY BYPASS, THE HEART WAS ELEVATED TO ASSESS THE POSTERIOR WALL. DURING THIS MANEUVER, THE IMPELLA PUMP WAS OBSERVED TO HAVE CAUSED A LEFT VENTRICULAR PERFORATION. THE PERFORATION WAS IDENTIFIED AS BEING CAUSED BY THE PUMP RATHER THAN A GUIDEWIRE AND WAS ATTRIBUTED TO POSITIONING THE DEVICE DEEP FOR CROSS-CLAMP PLACEMENT. AS THE PATIENT WAS ALREADY ON CARDIOPULMONARY BYPASS, THE SURGICAL TEAM COMPLETED ALL DISTAL ANASTOMOSES PRIOR TO ADDRESSING THE INJURY. THE LEFT VENTRICULAR PERFORATION WAS REPAIRED WITH A PATCH, AND ADEQUATE HEMOSTASIS WAS ACHIEVED PRIOR TO REMOVAL OF THE AORTIC CROSS-CLAMP. THE IMPELLA DEVICE WAS NOT REMOVED AND REMAINS IMPLANTED, WITH THE PATIENT CURRENTLY STILL ON SUPPORT AND PENDING TRANSFER.

    Description of Event or Problem · 0

    UPDATED CLINICAL NARRATIVE: DECISION WAS MADE TO WITHDRAW CARE ON 5/11/2026. THE DEATH WILL BE CONSERVATIVELY REPORTED, HOWEVER IS UNLIKELY DUE TO THE EVENT DURING IMPLANT AND IS MOST LIKELY DUE TO THE PATIENT'S CRITICAL CLINICAL PRESENTATION OF STAGE E SHOCK. WHILE ON SUPPORT THE DEVICE FUNCTIONED WITHIN RANGE FOR P-8 5.0 L/MIN AND D5W WITH SODIUM BICARBONATE AS THE PURGE SOLUTION. A 57-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND DIABETES MELLITUS UNDERWENT ELECTIVE PLACEMENT OF AN IMPELLA 5.5 VIA THE RIGHT AXILLARY ARTERY ON (B)(6) 2026 AT 10:00 AM. DURING THE PROCEDURE, THE CARDIOTHORACIC SURGEON REPORTED DIFFICULTY POSITIONING THE AORTIC CROSS-CLAMP WITHOUT CONTACTING THE IMPELLA MOTOR HOUSING. TO FACILITATE CROSS-CLAMP PLACEMENT, THE IMPELLA PUMP WAS POSITIONED DEEPER WITHIN THE LEFT VENTRICLE. AFTER APPLICATION OF THE AORTIC CROSS-CLAMP AND WHILE THE PATIENT WAS ON CARDIOPULMONARY BYPASS, THE HEART WAS ELEVATED TO ASSESS THE POSTERIOR WALL. DURING THIS MANEUVER, THE IMPELLA PUMP WAS OBSERVED TO HAVE CAUSED A LEFT VENTRICULAR PERFORATION. THE PERFORATION WAS IDENTIFIED AS BEING CAUSED BY THE PUMP RATHER THAN A GUIDEWIRE AND WAS ATTRIBUTED TO POSITIONING THE DEVICE DEEP FOR CROSS-CLAMP PLACEMENT. AS THE PATIENT WAS ALREADY ON CARDIOPULMONARY BYPASS, THE SURGICAL TEAM COMPLETED ALL DISTAL ANASTOMOSES PRIOR TO ADDRESSING THE INJURY. THE LEFT VENTRICULAR PERFORATION WAS REPAIRED WITH A PATCH, AND ADEQUATE HEMOSTASIS WAS ACHIEVED PRIOR TO REMOVAL OF THE AORTIC CROSS-CLAMP. THE IMPELLA DEVICE WAS NOT REMOVED AND REMAINS IMPLANTED, WITH THE PATIENT CURRENTLY STILL ON SUPPORT AND PENDING TRANSFER.0

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404569 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026754209 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1