BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 15379915 · Received September 7, 2022

    Report

    Report Number
    MW5111905
    Event Type
    Death
    Date Received
    September 7, 2022
    Date of Event
    July 14, 2022
    Report Date
    September 4, 2022
    Manufacturer
    ABIOMED INC.
    Product Code
    OJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECENTLY READ YOUR FDA 2018 ARTICLE BY DEBORAH KONTZ ON THE IMPELLA HEART PUMP. I WOULD LIKE MY HUSBAND'S DEATH AS A RESULT OF THE IMPELLA PUMP TO BE INCLUDED IN THE FDA DATA. MY HUSBAND WAS TREATED WITH THE IMPELLA PUMP DURING A HIGH RISK PCI PROCEDURE ON (B)(6) 2022. REMOVING THE PUMP CATHETER CAUSED A SEVERE INTERNAL BLEED (RETROPERITONEAL) BOTCHED SURGERY CAUSED MY HUSBAND TO DIE SEVEN DAYS LATER. WE WERE TOLD THAT THERE WAS A RISK FOR DEATH, BUT HAD NO IDEA THE RISK WOULD BE FROM WITHDRAWING THE CATHETER AND PUNCTURING HIS FEMORAL ARTERY. HE LOST ABOUT 4 LITERS OF BLOOD WITHIN 30 MINUTES FOLLOWING THE SURGERY. THE PCI SURGERY APPEARED TO BE A SUCCESS BUT THE BLOOD LOSS PUT A STRAIN ON HIS ALREADY DEBILITATED AND REVASCULARIZED HEART. YOUR ARTICLE HELPED ME PROCESS WHETHER WE EVEN NEEDED TO DO THIS SURGERY AND IF THIS RISK WAS WORTH IT. IT SEEMS "EITHER DIE FROM THE EQUIPMENT MALFUNCTIONS" OR "DIE WITHOUT THE SURGERY"; PICK YOUR HARD. THANK YOU FOR ADDRESSING THE ISSUES WITH THIS IMPELLA PUMP. I HOPE THE FDA WILL INCLUDE MY HUSBAND'S CASE IN THEIR DATA. HIS NAME WAS (B)(6). HE WAS A PATIENT OF DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). HIS SURGERY WAS (B)(6) 2022 AND HE DIED (B)(6) 2022. REGARDS, (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2644908 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| D HEART MEDICATIONS FOR BLOOD PRESSURE PRESCRIBED BY HOSPITAL CARDIAC CARE UNIT.