BEUDAMED
    FDA Adverse Event Death Summary report: N

    J & J PREMOUNTED STENT

    MDR report key: 175636 · Received July 7, 1998

    Report

    Report Number
    175636
    Event Type
    Death
    Date Received
    July 7, 1998
    Date of Event
    March 25, 1998
    Report Date
    June 26, 1998
    Manufacturer
    JOHNSON & JOHNSON CORDIS CORP
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO RT RENAL ARTERY WITHOUT DIFFICULTY. A PCA AND STENT WAS ATTEMPTED TO THE LT RENAL ARTERY WITH A 5MM X 15MM J & J STENT AND THE STENT WAS NOTED TO BE AT THE FORWARD TIP OF THE BALLOON. THE BALLOON WAS NOT INFLATED. THE STENT HAD COME OFF THE DEPLOYMENT BALLOON WHEN BEING ADVANCED THROUGH THE GUIDE AND HAD NOT BEEN INFLATED OR DEPLOYED. ATTEMPTS TO TRY TO RECAPTURE STENT ON BALLOON WERE NOT SUCCESSFUL. MICROVENA SNARE WAS INTRODUCED ATTEMPTS WERE MADE TO PULL BACK THE STENT INTO THE #8 FRENCH SHEATH OR A #10 SHEATH WITHOUT SUCCESS. STENT WAS SNARED BUT WAS NOT RUNNING PERPENDICULAR TO SHEATH AND WOULD NOT REENTER SHEATH. PT WAS TAKEN TO SURGERY TO HAVE STENT REMOVED. LT FEMORAL ENDARTERECTOMY AND PATCH ANGIOPLASTY. PT DEVELOPED RETROPERITONEAL BLEED, SHOCK, SEPSIS, THROMBOCYTOPENIA AND EVENTUALLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J PREMOUNTED STENT Implant 5MM X 15MM J & J PREMOUNTED STENT FGE JOHNSON & JOHNSON CORDIS CORP P1505 126524

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death