BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2001670 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01204
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: EVALUATION OF THE RETURNED PRODUCT FOUND BLOOD VISIBLE ON THE SHAFT AND CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION AND HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE TIP WAS SEPARATED AT THE DISTAL END OF THE DISTAL SEAL AND WAS NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. THE MATERIAL AT THE SEPARATION WAS JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE INNER DIAMETER OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. FACTORS THAT CAN CONTRIBUTE TO TIP DETACHMENT INCLUDE BUT ARE NOT LIMITED TO MANUFACTURING, REMOVAL FROM PACKAGING AT THE ACCOUNT, HANDLING DURING PREPARATION/USE, OR INSERTION OF THE GUIDE WIRE. TO HELP ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL PRODUCTS ARE SUBJECT TO A 100% VISUAL INSPECTION FOR TIP DAMAGE, INCLUDING THE POINT WHERE THE PROTECTIVE SHEATH IS PLACED OVER THE BALLOON PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY TIP PULL FORCE. RETURN OF THE SEPARATED TIP PORTION MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THE TIP WAS INADVERTENTLY HANDLED DURING PREPARATION; HOWEVER THIS COULD NOT BE CONFIRMED. 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 REPORT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED TIP DETACHMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHILE FLUSHING THE DEVICE, THE TIP OF THE STENT DELIVERY SYSTEM DETACHED AND FELL INTO THE SALINE BUCKET. THE DEVICE WAS NEVER USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER VISION STENT. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0100741

    Patients

    Seq Age Sex Outcome Treatment
    1