BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904597 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02492
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN, WHICH IS CONSISTENT WITH THE SDS ADVANCED OVER A GUIDE WIRE INTO THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND MILDLY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE HYPOTUBE AND JACKET WERE SEPARATED 1 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATION. THE JACKET WAS STRETCHED AND JAGGED AT THE SEPARATION. THE HYPOTUBE WAS KINKED AT THE DISTAL END OF THE STRAIN RELIEF TUBING. THERE WERE MULTIPLE KINKS IN THE HYPOTUBE BETWEEN THE SEPARATION AND 7 CM DISTAL TO IT. THERE WAS A KINK IN THE DISTAL SHAFT 1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. 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 SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. AN ATTEMPT WAS MADE TO OBTAIN CLARIFICATION ON WHEN THE HYOTUBE MAY HAVE SEPARATED. FOLLOW UP INFORMATION RECEIVED FROM THE ACCOUNT WAS UNABLE TO DETERMINE WHEN EXACTLY THE HYPOTUBE SEPARATED HOWEVER IT MAY HAVE SEPARATED DURING THE ATTEMPT TO CROSS THE LESION. IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE TORTUOUS AND CALCIFIED LESION MAY HAVE RESULTED IN A KINK IN THE HYPOTUBE. FURTHER HANDLING COULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE AND NOTED HYPOTUBE SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION HAD MILD CALCIFICATION. THE 2.75 X 15 MM PROMUS STENT DELIVERY SYSTEM DID NOT CROSS. A NEW PROMUS WAS PLACED. THE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE AND JACKET WERE SEPARATED 1 CM DISTAL TO THE STRAIN RELIEF TUBING. 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 US.

    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-CLONMEL 9120341

    Patients

    Seq Age Sex Outcome Treatment
    1