BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1818051 · Received August 20, 2010

    Report

    Report Number
    2024168-2010-01712
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED RX VISION STENT DELIVERY SYSTEM (SDS) THAT THE STENT IMPLANT WAS UNDAMAGED AND STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. ADDITIONALLY, MEASUREMENTS OF THE ENTIRE TIP LENGTH AND THE OUTER DIAMETERS OF THE STENT IMPLANT WERE TAKEN AND ALL DIMENSIONS MET MFG CRITERIA. ALTHOUGH, NO SPECIFIC PT ANATOMICAL INFO WAS PROVIDED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE ANALYSIS DID CONFIRM THAT THE HYPOTUBE SHAFT, INCLUDING THE JACKET MATERIAL, WAS SEPARATED 21.7 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES OF THE HYPOTUBE WERE OVALED, INDICATING THAT THE HYPOTUBE HAD BENT OR KINKED PRIOR TO FRACTURING. ADDITIONALLY, BOTH ENDS OF THE SEPARATED JACKET MATERIAL WERE ALSO JAGGED AND STRETCHED WHICH IS USUALLY A RESULT OF TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE ANALYSIS FURTHER NOTED A KINK IN THE HYPOTUBE LOCATED 1.4 CM DISTAL TO THE SEPARATION, A BEND IN THE HYPOTUBE 2 CM PROXIMAL TO THE SEPARATION AND A BEND AT THE DISTAL END OF THE STRAIN RELIEF TUBING. HOWEVER, THE KINK/BENDS MAY HAVE OCCURRED DURING USE OR FROM HANDLING AFTER THE PROCEDURE, AS NO DAMAGE WAS REPORTED TO THE SDS DURING THE INSPECTION PRIOR TO USE. 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. IN THIS CASE, IT IS POSSIBLE THAT AN ATTEMPT TO CROSS THE LESION AS RESISTANCE WAS ENCOUNTERED LIKELY CONTRIBUTED TO THE KINK/BENDS AND REPORTED SHAFT SEPARATION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. FURTHERMORE, FACTORS THAT MAY CONTRIBUTE TO SHAFT SEPARATIONS DURING USE INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MFG, MATERIALS, HANDLING PRIOR TO AND DURING THE PROCEDURE, REMOVAL TECHNIQUE FROM THE PACKAGING, AN INTERACTION WITH THE PT ANATOMY OR ASSOCIATIVE DEVICE INTERACTION. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD 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 MFG CRITERIA. IN THIS INSTANCE, BASED ON THE INFO RECEIVED WITH THIS COMPLAINT AND THE RETURNED PRODUCT ANALYSIS, THE REPORTED FAILURE TO ADVANCE, SHAFT SEPARATION AND KINKS/BENDS APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ONLINE DURING THE MFG PROCESS AT ABBOTT VASCULAR. ADDITIONALLY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED ONLINE FOR KINKS AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY SHAFT INTEGRITY AND TENSILE STRENGTH.

    Description of Event or Problem · 1

    DEVICE ISSUE: SEPARATED PROXIMAL SHAFT. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING AN ATTEMPT TO CROSS A LESION WITH ONE OF THE VISION STENTS (LOT# 0012041), THE SHAFT SEPARATED. NO INTERVENTION OR PT INJURY WAS REPORTED. THE OTHER VISION WAS ATTEMPTED, BUT DURING THE CROSSING ATTEMPT, THE SHAFT BECAME KINKED AND UPON REMOVAL, THE DISTAL END OF THE STENT WAS NOTED TO BE BENT. THERE IS NO ADD'L EVENT OR PT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 0012041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK