BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2011856 · Received March 9, 2011

    Report

    Report Number
    2024168-2011-01537
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 15, 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. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE STRUTS AND ORANGE PROTECTIVE SHEATH, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS RETURNED INSIDE THE ORANGE PROTECTIVE SHEATH. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED. 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 SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER DURING THE MANUFACTURING PROCESS. ADDITIONALLY, DURING THE MANUFACTURING PROCESS, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. THE INNER DIAMETER OF THE PROTECTIVE SHEATH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. RETURN OF THE SDS MAY HAVE AIDED IN THE INVESTIGATION. IT IS POSSIBLE THE PROTECTIVE SHEATH WAS INADVERTENTLY HANDLED DURING REMOVAL, RESULTING IN THE STENT DISLODGING. 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. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION, WHEN THE STYLET WAS BEING REMOVED FROM THE CATHETER, THE STENT CAME OFF THE BALLOON ALONG WITH THE STYLET. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED 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 0113041

    Patients

    Seq Age Sex Outcome Treatment
    1