BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3962032 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04398
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    June 21, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE >THAN 80% STENOSED, DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS CROSSED WITH A NON-BSC GUIDE WIRE. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED 2X9MM BALLOON CATHETER FOR 15 SECS AT 8 ATMS. THIS 2.25X24MM PROMUS ELEMENT STENT WAS SELECTED AND WAS DEPLOYED AT 14 ATMS FOR 25 SECS. POST-DILATION WAS COMPLETED WITH A 2.5X12MM NC BALLOON CATHETER AT 16ATM FOR 15 SECS. A FINAL CONTROL ANGIOGRAM REVEALED A WELL DEPLOYED STENT WITH TIMI FLOW OF III. THE PATIENT WAS DISCHARGED TWO DAYS LATER. FIVE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED SEVERE CHEST PAINT. AN ANGIOGRAM OF THE PROXIMAL LAD REVEALED SUB-ACUTE THROMBOSIS IN THE STENTED SEGMENT WITH 100% OCCLUSION; THIS WAS CROSSED WITH A NON-BSC GUIDE WIRE AND DILATION WAS COMPLETED WITH A 2X9MM BALLOON CATHETER AT 16ATMS FOR 15 SECS. A 2.5X12MM NC BALLOON CATHETER WAS ALSO INFLATED AT 12 ATMS FOR 15 SECS. A REPEAT ANGIOGRAM SHOWED A TIMI FLOW OF II WITH THROMBUS PRESENT AT THE MID PORTION OF THE STENT. AN INJECTION OF NIKORAN AND AN INTRACORONARY ABCIXIMAB BOLUS WERE GIVEN AND THE PATIENT WAS SHIFTED TO THE ICCU. OVER A PERIOD OF TIME, PATIENT HAD ST ELEVATION CHANGES AND WAS SHIFTED BACK TO CATH LAB FOR AN ANGIOGRAM WHICH REVEALED THE SAME AS PREVIOUSLY REPORTED WITH SLOW FLOW AT LAD. REPEAT DILATATION WAS COMPLETED WITH A 2.5X10MM NC BALLOON. IN BETWEEN THE PATIENT DEVELOPED HYPOTENSION, FOR BETTER CORONARY PERFUSION, IABP WAS INSERTED THROUGH RIGHT FEMORAL ARTERY WITH 1:1 AUGMENTATION AND THE PATIENT WAS SHIFTED TO ICCU. PATIENT WAS ON IABP SUPPORT FOR MORE THAN 2 DAYS AND ON 3RD DAY EARLY MORNING, THEY EXPERIENCED CARDIAC ARREST. THEY FOLLOWED THE ACLS PROTOCOL BUT PATIENT COULDN¿T BE REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437803 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death GUIDE WIRE:BMW| GUIDE CATHETER:6 FR ¿ EBU