BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2001920 · Received February 27, 2011

    Report

    Report Number
    2024168-2011-01232
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 23, 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
    OK, 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE DISTAL SHAFT CONSISTENT WITH HANDLING. THE STENT WAS NOT RETURNED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IT IS POSSIBLE THE STENT WAS INADVERTENTLY HANDLED DURING REMOVAL OF THE PROTECTIVE SHEATH, RESULTING IN THE STENT DISLODGEMENT; 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 AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR MISSING/DISLODGED STENTS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE STENT DISLODGEMENT COULD NOT BE CONFIRMED. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE RX VISION, THE DELIVERY SYSTEM WAS FOUND WITH NO STENT ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT STENT WAS USED INSTEAD. THERE WAS NO ADDITIONAL INFORMATION 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 0040241

    Patients

    Seq Age Sex Outcome Treatment
    1