BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3030163 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01860
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: AGE AT TIME OF EVENT UPDATE FROM (B)(6). EVENT DATE UPDATE FROM (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE STENT WAS RETURNED SEVERELY DAMAGED (CRUSHED) AND SEPARATE FROM THE SDS SYSTEM. MICROSCOPIC EXAMINATION OF THE BALLOON NOTED THAT THE STENT HAD BEEN CRIMPED ON THE BALLOON, AS INDENTATIONS ON THE PROFILE OF THE BALLOON HAD LEFT A DISTINCT IMPRINT OF THE CRIMPED STENT. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: (B)(4). IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEVERE RIGHT CAD WITH COMPLEX 95% MID LESION, ECCENTRIC 70% DISTAL LESION, DIFFUSE 50% DISTAL LESION, 3 PREVIOUS STENTS WERE PLACED WITH 0% RESIDUAL STENOSIS. ALSO TUBULAR 50% PROXIMAL LAD LESION AND 30% TUBULAR PROXIMAL CIRCUMFLEX LESION.

    Description of Event or Problem · 1

    (B)(4). IT WAS FURTHER REPORTED THAT THE PATIENT HAD SEVERE RIGHT CAD WITH COMPLEX 95% MID LESION, ECCENTRIC 70% DISTAL LESION, DIFFUSE 50% DISTAL LESION, 3 PREVIOUS STENTS WERE PLACED WITH 0% RESIDUAL STENOSIS. ALSO TUBULAR 50% PROXIMAL LAD LESION AND 30% TUBULAR PROXIMAL CIRCUMFLEX LESION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY TREATMENT PROCEDURE,REMOVAL DIFFICULTIES AND STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATION OF THE MID TO DISTAL PORTION OF THE LESION WAS COMPLETED WITH AN UNSPECIFIED BALLOON CATHETER. THIS 3.50X12MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WAS SELECTED; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. DURING REMOVAL RESISTANCE WAS MET. IT WAS NOTED THAT WHEN PULLING THE SDS, THE GUIDE WIRE AND THE GUIDE CATHETER INTO THE BSC-SHEATH THE STENT BECAME STUCK ON THE ONE WAY VALVE INSIDE THE SHEATH AND THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENT. THE SDS WAS NOT REUSED; THE SAME GUIDE WIRE AND GUIDE CATHETER WAS SUCCESSFULLY USED TO CROSS THE LESION AND A 3.0X12MM PROMUS ELEMENT WAS DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134150 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412350 15492300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INTRODUCER SHEATH| GUIDE WIRE| GUIDE CATHETER