BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1872388 · Received October 11, 2010

    Report

    Report Number
    2024168-2010-02138
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE HUB, SHAFT, BALLOON, STENT, AND IN THE GUIDE WIRE LUMEN AND HUB. THE STENT WAS LOOSE ON THE BALLOON. THERE WERE BENT AND TWISTED STRUTS IN THE FIRST ROW OF DISTAL STRUTS AND BENT AND FLARED STRUTS IN THE FIRST THREE ROWS OF PROXIMAL STRUTS. THE SIXTH, SEVENTH, AND EIGHTH ROWS OF DISTAL STRUTS WERE MANGLED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE DISTAL BALLOON TAPER WAS BUNCHED. SEVERAL ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION FROM THE ACCOUNT AS TO WHEN THE NOTED DAMAGE OCCURRED; HOWEVER, NO FURTHER INFO WAS AVAILABLE. IT IS POSSIBLE THE LOOSE STENT, STENT DAMAGE, AND BUNCHED BALLOON MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR. THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED 21.8 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVAL AS IF KINKED PRIOR TO SEPARATION. THE MATERIAL AT THE SEPARATION WAS STRETCHED. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE STENT DELIVERY SYSTEM (SDS) MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MFG DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. THERE WERE MULTIPLE KINKS AND BENDS NOTED TO THE SDS. IN THIS CASE, IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE HIGHLY CALCIFIED AND TORTUOUS LESION MAY HAVE RESULTED IN A KINK IN THE HYPOTUBE. FURTHER HANDLING COULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. A CONCLUSIVE CAUSE FOR THE NOTED LOOSE STENT, BUNCHED BALLOON, AND STENT DAMAGE COULD NOT BE DETERMINED; HOWEVER, THE REPORTED HYPOTUBE SEPARATION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MFG RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO ADVANCE THE PROMUS 2.5 X 18 STENT TO THE HIGHLY CALCIFIED AND TORTUOUS CIRCUMFLEX LESION, THE SHAFT OF THE PROMUS STENT DELIVERY SYSTEM (SDS) KINKED AND THEN FRACTURED. THE PHYSICIAN DECIDED NOT TO TRY TO AGAIN DUE TO THE HIGHLY CALCIFIED NATURE OF THE LESION. REPORTEDLY, THERE WERE NO PT EFFECTS. THOUGH REQUESTED, NO ADD'L EVENT OR PT INFO IS AVAILABLE. ALTHOUGH NOT REPORTED, THE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS LOOSE ON THE BALLOON AND THE STENT STRUTS WERE BENT, FLARED, AND MANGLED. IT COULD NOT BE CONFIRMED WHEN THE STENT BECAME LOOSE ON THE BALLOON. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0053141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR