BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1962178 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00361
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE ON THE SHAFT, BALLOON, STENT, AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT. THIS IS CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE THREE STRUTS IN THE FIRST ROW OF PROXIMAL STRUTS THAT WERE STRETCHED AND BEND BACK TOWARDS THE TIP. THERE WERE CLEAR FIBERS WRAPPED AROUND THE BENT STRUTS AND AROUND THE SHAFT AT THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE CLEAR FIBERS MAY HAVE COME IN CONTACT WITH THE SDS DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE DISTAL BALLOON TAPER WAS WRINKLED WHICH LIKELY OCCURRED DURING ADVANCEMENT IN THE LESION. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED 18.7 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED INFORMATION. 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. THERE WERE MULTIPLE KINKS NOTED TO THE HYPOTUBE. 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. IN THIS CASE, THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING RETRACTION IN THE CALCIFIED LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE TO THE STENT, FURTHER CONTRIBUTING TO THE REPORTED RESISTANCE DURING RETRACTION, AND LIKELY CONTRIBUTING TO THE SHAFT KINKING AS RESISTANCE WAS ENCOUNTERED. FURTHER MANIPULATION OF THE SHAFT WOULD HAVE RESULTED IN THE SHAFT ULTIMATELY SEPARATING. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR KINKS. ADDITIONALLY, A SAMPLING OF PRODUCT IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE, HYPOTUBE KINKS, AND SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR DESCENDING ARTERY STENTING PROCEDURE, IN A HEAVILY CALCIFIED ARTERY, AFTER PRE-DILATATION, THE MINI VISION STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION. RESISTANCE WAS FELT DURING REMOVAL AND UPON REMOVAL, THE PROXIMAL SHAFT BROKE IN TWO PIECES. ADDITIONALLY, SEVERAL AREAS ON THE SHAFT WERE KINKED. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0030541

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR