BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1940910 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05628
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 A STENTING TREATMENT PROCEDURE, ANGINA AND STENT FRACTURE WITH DETACHMENT OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH DIFFUSE THROMBOSIS OF A NON BSC STENT. THE 80% OCCLUDED LESION WAS LOCATED IN THE MEDIAL RCA CLOSE TO THE OSTIUM. A 3.5X12MM NON BSC STENT AND A 2.5X16MM PROMUS ELEMENT STENT WERE PLACED IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. TEN DAYS LATER IT WAS CONFIRMED VIA ANGIOGRAPHY THAT THE DRUG ELUTING STENTS TO THE OSTIAL AND PROXIMAL STENT AREAS WERE WITHOUT RESTENOSIS. THE NON BSC STENT DID SHOW SOME CHANGES TO THE OSTIUM WALL. IN (B)(6) 2010, THE PATIENT PRESENTED FOR A DIAGNOSTIC CATHETERIZATION FOR CONTINUING STABLE ANGINA. THE 80% IN-STENT RESTENOSED ECCENTRIC LESION WAS LOCATED IN A NON TORTUOUS RIGHT CORONARY ARTERY. IVUS WAS PERFORMED SHOWING GOOD STENT EXPANSION AND PROLAPSED CALCIFIED PLAQUE INTO THE LUMEN WITH SHIFTING. NO EVIDENCE OF THROMBUS WAS PRESENT. THE LESION WAS DIRECT STENTED WITH A 3.5X12MM PROMUS ELEMENT STENT AND POSTDILATION WAS PERFORMED WITH A 3.75MM NON-COMPLAINT BALLOON. NO RESIDUAL STENOSIS REMAINED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS PLACED ON ASPIRIN AND PRASUGREL FOR ONE YEAR, WITH FOLLOW-UP ANGIOGRAPHY SCHEDULED IN 6 MONTHS. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ANGINA AND PROGRESSIVE DYSPNEA ON EXERTION. THE ECCENTRIC IN-STENT RESTENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS RIGHT CORONARY ARTERY. IT WAS NOTED THAT AS THE HEART WOULD BEAT, FRACTURES WITH DETACHMENTS IN TWO PREVIOUSLY PLACED STENTS COULD BE DISCERNED. 3-4MM OF THE PROXIMAL OSTIAL PORTION OF A 3.5X12MM NON BSC STENT AND AN OVERLAPPING 3.5X12MM PROMUS ELEMENT STENT WERE FRACTURED. NO FURTHER TREATMENT WAS PERFORMED. CABG IS BEING CONSIDERED FOR FUTURE TREATMENT. PATIENT STATUS IS LISTED AS STABLE. THIS DEVICE IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 0013469322

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other 6FR JR4 GUIDE CATHETER| BMW GUIDE WIRE| 3.75MM NC BALLOON