BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2162726 · Received July 14, 2011

    Report

    Report Number
    2024168-2011-04966
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 17, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURES/BREAKS OUT OF THE PACKAGE INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, AND HANDLING DURING PREPARATION FOR USE. TO HELP ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, INCLUDING AT THE POINT THAT THE PROTECTIVE SHEATH IS PLACED OVER THE BALLOON. RETURN DEVICE ANALYSIS NOTED BLOOD ON THE BALLOON AND SHAFT, WHICH IS CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON BETWEEN THE MARKERS. THE BROKEN STENT WAS NOT CONFIRMED, AS NO DAMAGE WAS NOTED TO THE STENT. THE ACCOUNT WAS CONTACTED TO DETERMINE IF THE INCORRECT PRODUCT WAS INADVERTENTLY RETURNED. THE RESPONSE INDICATED THAT THE COMPLAINT DEVICE WAS RETURNED. THE PHYSICIAN BELIEVED THE STENT WAS BROKEN, BUT WAS NOT SURE. THERE WAS HOWEVER, A KINK IN THE HYPOTUBE (BAYONET) AT THE PROXIMAL END OF THE GUIDE WIRE EXIT NOTCH. SINCE THIS DAMAGE WAS NOT ORIGINALLY REPORTED IN THE CASE DESCRIPTION, THE SHAFT LIKELY BENT FROM FURTHER HANDLING AFTER THE PROCEDURE AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER INCIDENTS FOR STENT DAMAGE OR KINKS/BENDS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE RX VISION STENT SYSTEM, IT WAS NOTED THAT THE STENT WAS BROKEN. THE STENT SYSTEM WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A MULTI-LINK VISION STENT SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 9011541

    Patients

    Seq Age Sex Outcome Treatment
    1