BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2192766 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05532
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) NOTED A KINK IN THE DISTAL SHAFT 6 CM PROXIMAL TO THE PROXIMAL SEAL, CONFIRMING THE REPORTED KINK. THE STENT IMPLANT WAS RETURNED LOOSE ON THE BALLOON WITH THE DISTAL END FACING PROXIMALLY. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. FOLLOW UP INFORMATION RECEIVED FROM THE ACCOUNT NOTED THAT THE LOOSE STENT WAS NOT NOTED DURING THE PROCEDURE; THEREFORE, IT IS LIKELY THAT THE STENT WAS INADVERTENTLY HANDLED DURING PACKING FOR RETURN ANALYSIS RESULTING IN THE STENT DISLODGING FROM THE BALLOON. THE STENT WAS LIKELY PLACED BACKWARDS ON THE BALLOON FOR RETURN ANALYSIS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE DISTAL AND PROXIMAL STENT OUTER DIAMETER DIMENSIONS WERE OUTSIDE OF THE ACCEPTED MANUFACTURING SPECIFICATION, HOWEVER, BECAUSE STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WITHIN THE REQUIRED SPECIFICATION, THIS OVER-SIZING MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON SHOULDERS. THE VERY DISTAL END OF THE SOFT TIP HAD STRETCHED MATERIAL. THERE WAS BALLOON SHREDDING AT THE DISTAL END OF THE BALLOON. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE LESION OR DURING HANDLING OF THE STENT POST PROCEDURE. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. 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. THE PATIENT ANATOMY WAS MILDLY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT THE SHAFT KINKED AS RESISTANCE WAS ENCOUNTERED IN THE LESION AS THERE WAS NO DAMAGE NOTED TO THE SDS DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, DURING MANUFACTURING, ALL SDS ARE 100% CHECKED FOR DAMAGE AND CRIMPED STENT PROFILE. ADDITIONALLY, IT IS LIKELY THAT AN INTERACTION WITH THE CALCIFIED LESION CONTRIBUTED TO THE NOTED TIP DAMAGE. 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 INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR LOOSE OR DISLODGED STENTS OR BALLOON SHREDDING FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION OF THE TARGET LESION IN THE DIAGONAL ARTERY WAS PERFORMED PRIOR TO THE ATTEMPT TO STENT. A MULTI-LINK VISION 3.50 X 15 WAS ADVANCED. DURING THE ATTEMPT TO CROSS THE MILDLY CALCIFIED LESION IN THE LEFT DESCENDING ARTERY, THE SHAFT OF THE DEVICE KINKED. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE STENT IMPLANT WAS LOOSE ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0112441

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR