BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2060179 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02654
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND ON THE DISTAL SHAFT, CONSISTENT WITH PREPARATION AND A LEAK WHILE IN THE PATIENTS ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE OUTER MEMBER WAS STRETCHED 5.5 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH FOR A LENGTH OF 2 MM. THE OUTER MEMBER WAS SEPARATED AT THE PROXIMAL END OF THE STRETCHED AREA. THE MATERIAL WAS JAGGED AT THE SEPARATION WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE INNER MEMBER WAS NOT SEPARATED. THERE WAS A HOLE, 1.5 MM IN LENGTH, IN THE INNER MEMBER AND OUTER MEMBER 8.2 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL. THE OUTER MEMBER WAS SCRAPED 1MM PROXIMAL AND 1.5 MM DISTAL TO THE HOLE. THE DISTAL SHAFT WAS PINCHED AT THAT SAME LOCATION FOR A LENGTH OF 5 MM. THERE IS NO OTHER DAMAGE NOTED TO THE STENT DELIVERY SYSTEM. FACTORS THAT MAY CONTRIBUTE TO A TEAR IN THE SHAFT INCLUDE, BUT ARE NOT LIMITED TO: MANUFACTURING, HANDLING OF THE PRODUCT DURING PREPARATION/USE, AND/OR INTERACTION WITH THE GUIDING CATHETER AND/OR LESION/ANATOMY. TO HELP ENSURE THAT THIS DAMAGE IS NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR DAMAGE, INCLUDING AT THE POINT WHERE THE CATHETER IS INSERTED INTO THE PACKAGING COIL. ADDITIONALLY, ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO PACKAGING AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE CATHETER BODY INTEGRITY PRIOR TO RELEASE. THE PATIENTS ANATOMY WAS MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE SHAFT DAMAGE, AS THERE WAS NO DAMAGE NOTED PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IT IS POSSIBLE THE SHAFT INTERACTED WITH THE MODERATELY CALCIFIED LESION RESULTING IN THE NOTED DAMAGE TO THE SHAFT AND THE DIFFICULTY INFLATING THE BALLOON. FURTHER, IT IS POSSIBLE THE NOTED STRETCHING AND OUTER MEMBER SEPARATION OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS AS IT WAS NOT REPORTED IN THE CASE INFORMATION; HOWEVER THIS COULD NOT BE CONFIRMED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES, SHAFT DAMAGE, OR TEARS IN THE SHAFT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY INFLATING THE BALLOON APPEARS TO BE RELATED TO THE TEAR IN THE SHAFT; HOWEVER A CONCLUSIVE CAUSE FOR THE NOTED STRETCHING, SEPARATED AND DAMAGED SHAFT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, WHICH WAS MILDLY TORTUOUS AND 90% STENOSED. PRE-DILATATION WAS PERFORMED PRIOR TO ADVANCEMENT OF THE 3.0 X 28 PROMUS STENT DELIVERY SYSTEM (SDS). THE SDS WAS PRESSURIZED TWICE TO 6 ATMOSPHERES, BUT THE BALLOON WOULD NOT INFLATE. THE SDS WAS REMOVED AND A NEW SAME SIZE PROMUS STENT WAS DEPLOYED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0102261

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR