BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3063052 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02366
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WITH THE STENT DETACHED FOLDED IN A PIECE OF SURGICAL TAPE WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE STENT WASN'T ABLE TO BE REMOVED FROM THE SURGICAL TAPE. VISUAL INSPECTION OF THE STENT THROUGH THE SURGICAL TAPE SHOWED THAT THE STENT WAS COMPLETELY FLATTENED. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH STENT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS. THE HYPOTUBE WAS SEPARATED 21.75CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE SHAFT WAS SEPARATED AT THE HYPOTUBE AND MIDSHAFT BOND 35CM FROM THE DISTAL TIP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SHAFT BROKE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS 3RD OBTUSE MARGINAL ARTERY. THE 2.25X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER THERE WAS DIFFICULTY IN PUSHING DEVICE. BECAUSE OF EXCESSIVE MANIPULATION OUTSIDE THE GUIDE CATHETER, THE CATHETER BROKE IN HALF OUTSIDE THE PATIENT. THE DEVICE WAS PULLED OUT WITH THE BROKEN HALF STILL HANGING OUT OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165115 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911412250 15430799

    Patients

    Seq Age Sex Outcome Treatment
    1