BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930992 · Received December 17, 2010

    Report

    Report Number
    2134265-2010-05527
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH STENT DAMAGE. STRUT ROW 6 FROM THE DISTAL END OF THE STENT WAS RAISED SLIGHTLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THERE WAS A KINK IN THE LUMEN 175MM DISTAL TO THE TIP. THERE WERE KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE SYSTEM. SOLIDIFIED CONTRAST MEDIA AND BLOOD WERE PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED AND USED IN VIVO.THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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 MFR# 2134265-2010-05528. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE AND WITHDRAWAL RESISTANCE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5X14MM BALLOON AT 12ATMS. A 3.0X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND DURING ATTEMPTS TO ADVANCE THE SDS, THE STENT BECAME DAMAGED. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED WITHDRAWAL RESISTANCE WHILE TRYING TO REMOVE THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN PREDILATED THE LESION AGAIN AND A NEW 3.0X16MM PROMUS ELEMENT SDS WAS ADVANCED TO THE LESION. HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION AND THE STENT BECAME DAMAGED WHILE ADVANCING. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X18MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2010-05528. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE AND WITHDRAWAL RESISTANCE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.5X14MM BALLOON AT 12ATMS. A 3.0X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED TO THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND DURING ATTEMPTS TO ADVANCE THE SDS, THE STENT BECAME DAMAGED. IT WAS NOTED THAT THE PHYSICIAN EXPERIENCED WITHDRAWAL RESISTANCE WHILE TRYING TO REMOVE THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN PREDILATED THE LESION AGAIN AND A NEW 3.0X16MM PROMUS ELEMENT SDS WAS ADVANCED TO THE LESION. HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION AND THE STENT BECAME DAMAGED WHILE ADVANCING. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X18MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. THIS PRODUCT 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 H7493911316300 13589392

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR BMW GUIDE WIRE| JUTKINS LEFT 4.5 6F GUIDE CATHETER