BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1699094 · Received May 24, 2010

    Report

    Report Number
    2024168-2010-01039
    Event Type
    Death
    Date Received
    May 24, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 29, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE STENT REMAINS IN THE PT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO DEPLOY. ADVERSE EVENT: PERFORATION/DEATH. ONSET OF ADVERSE EVENT: DURING PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE IN THE PREDILATED PROXIMAL CIRCUMFLEX ARTERY, THE PROMUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WOULD NOT CROSS. THE SDS WAS REMOVED AND DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON. THE SDS WAS ADVANCED AND CROSSED THE LESION. THE STENT WAS DEPLOYED AT 16 ATMOSPHERES; HOWEVER, THERE WAS A PERSISTENT DOG BONE EFFECT; THEREFORE, THE BALLOON WAS INFLATED TO 20 ATMOSPHERES. AFTER REMOVING THE SDS, A PERFORATION WAS OBSERVED. THE SDS WAS ADVANCED AND THE BALLOON WAS INFLATED AT THE PERFORATION SITE FOR AN EXTENDED PERIOD OF TIME; HOWEVER, BLEEDING AND TAMPONADE CONTINUED WHEN THE BALLOON WAS DEFLATED. A BALLOON PUMP AND A PERICARDIAL DRAIN WERE INSERTED. THE PT BECAME HYPOTENSIVE AND DEVELOPED VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION AND ASYSTOLE. A TRANSVENOUS PACEMAKER WAS INSERTED. RESUSCITATION ATTEMPTS WERE MADE; HOWEVER, THE PT EXPIRED IN THE CATH LAB. THOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED. YOU ARE RECEIVING THIS REPORT FROM ABBOTT VASCULAR BECAUSE (B) (4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| L| R GUIDE WIRE: BMW (X2)| SHEATH: AVANTI 5F| DIL CATH: 2.0X12, 2.5X12 APEX| GUIDE CATH: VISTA XB 3.5