BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2223653 · Received August 25, 2011

    Report

    Report Number
    2024168-2011-05941
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 30, 2011
    Report Date
    August 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 BALLOON, WHICH IS CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON, CONFIRMING THE REPORTED COMPLAINT. THERE WERE BENT STRUTS IN THE MIDDLE OF THE STENT. HOWEVER, AS THIS DAMAGE WAS NOT ORIGINALLY REPORTED IN THE CASE DESCRIPTION, THE STENT STRUTS MAY HAVE BECOME BENT AT SOME POINT DURING THE PROCEDURE OR FROM HANDLING AS THE DEVICE WAS PACKAGED FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THERE WERE CRIMP MARKS VISIBLE ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. ADDITIONALLY, MEASUREMENTS OF THE OUTER DIAMETER OF THE STENT AT THE DISTAL AND PROXIMAL ENDS WERE TAKEN AND BOTH DIMENSIONS WERE WITHIN MANUFACTURING SPECIFICATION. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS ALSO MEASURED AND MET MANUFACTURING CRITERIA. THE MIDDLE OF THE STENT COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE ATENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IF SIGNIFICANT PRESSURE WAS INADVERTENTLY APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH, THIS MAY HAVE CAUSED THE STENT TO BECOME DAMAGED AND DISRUPTED ON THE BALLOON, THEREBY FACILITATING STENT DISLODGEMENT. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR STENT MOVEMENT TO VERIFY STENT SECURITY AND DISLODGEMENT FORCE. A REVIEW OF THE FINISHED PRODUCT ELECTRONIC LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT, INDICATING THAT ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FOR STENT DISLODGEMENT FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.75 X 12 MM VISION STENT DISLODGED FROM THE BALLOON DURING PREPARATION, UPON REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. 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 1040541

    Patients

    Seq Age Sex Outcome Treatment
    1