BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2171695 · Received July 22, 2011

    Report

    Report Number
    2024168-2011-05072
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE OUTER MEMBER, CONSISTENT WITH ADVANCEMENT OF THE STENT DELIVERY SYSTEM (SDS) INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WERE MULTIPLE KINKS AND BENDS NOTED TO THE SDS. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. 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 ARE NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND IS LIKELY RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE WAS BALLOON PEELING ON THE DISTAL AND PROXIMAL ENDS OF THE BALLOON WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFORMATION. THE BALLOON PEELING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE LESION. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. IT IS POSSIBLE THAT THE BALLOON MAY HAVE SCRAPED AGAINST THE LESION, WHICH CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT 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 BALLOON PEELING FOR THIS LOT. THE REPORTED DIFFICULTIES 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 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 THE 3.0 X 18 AND 2.75 X 12 VISION STENTS DID NOT CROSS THE LESION IN THE MID/DISTAL RIGHT CORONARY ARTERY. THE PATIENT WAS TREATED SATISFACTORILY WITH A 3.0 X 8 AND A 2.5 X 8 VISION STENT. THE PATIENT EXPERIENCED NO UNTOWARD EFFECTS AS A RESULT OF THE FAILURE TO CROSS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THAT THE 3.0 X 18 VISION BALLOON WAS PEELING.

    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 0101941

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR