BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1904642 · Received November 22, 2010

    Report

    Report Number
    2024168-2010-02459
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. EVALUATION SUMMARY: THE RX VISION STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON, WHICH IS CONSISTENT WITH HANDLING AND/OR USE OF THE DEVICE. THE STENT WAS UNDAMAGED AND STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. ADDITIONALLY, MEASUREMENTS OF THE OUTER DIAMETER OF THE STENT AND THE ENTIRE TIP LENGTH WERE TAKEN AND ALL DIMENSIONS MET MANUFACTURING SPECIFICATION. ALTHOUGH NO PATIENT ANATOMICAL INFORMATION 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 CONFIRMED THAT THE HYPOTUBE SHAFT, INCLUDING THE JACKET MATERIAL, WAS FRACTURED AND SEPARATED 19.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WERE ALSO TWO KINKS NOTED IN THE HYPOTUBE ADJACENT TO THE SEPARATION AND ONE KINK IN THE SUPPORT MANDREL NEAR THE GUIDE WIRE EXIT NOTCH. THE FRACTURE FACES OF THE SEPARATION WERE OVALED, INDICATING THAT THE HYPOTUBE HAD BENT OR KINKED PRIOR TO FRACTURING. FURTHERMORE, BOTH ENDS OF THE SEPARATED JACKET MATERIAL WERE JAGGED AND STRETCHED, WHICH IS USUALLY A RESULT OF TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS PRIOR TO THE PROCEDURE, THIS SUGGESTS THAT THIS DAMAGE LIKELY OCCURRED DURING OR AFTER THE PROCEDURE. KINKS OR BENDS IN THE SHAFT CAN THEN LEAD TO WEAKENING OF THE SHAFT MATERIAL, SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING (KINKING, STRAIGHTENING, KINKING) CAN RESULT IN THE EVENTUAL FRACTURE OF THE HYPOTUBE. IF THE CATHETER INTERACTED WITH THE LESION DURING ATTEMPTED ADVANCEMENT, THIS LIKELY CAUSED THE SHAFT TO BEND/KINK, FRACTURE AND ULTIMATELY SEPARATE AS A RESULT. 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, DEVICE SIZE SELECTION, DAMAGE TO THE SDS OR THE STENT IMPLANT, INTERACTIONS WITH OTHER DEVICES, AND ACCESSORY DEVICE SUPPORT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED DEVICE, THE REPORTED FAILURE TO ADVANCE, SHAFT SEPARATION AND KINK DAMAGE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE AFTER AN RX VISION STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE RIGHT CORONARY ARTERY LESION AND BECAME BENT, AN RX VISION SDS ALSO WAS UNABLE TO CROSS THE LESION AND THE STENT BECAME "FRACTURED". THE DEVICE WAS REMOVED AND THE PROCEDURE WAS ABANDONED. NO INTERVENTION WAS PERFORMED. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED. THE FIRST RX VISION WAS SUBSEQUENTLY RETURNED AND HYPOTUBE SEPARATION WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 0060241

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR