BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2182413 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05346
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 26, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, WHICH MAY SUGGEST THAT THE DEVICE WAS PREPARED FOR USE AND LOADED ONTO A GUIDE WIRE AT SOME POINT. THIS IS INCONSISTENT WITH THE REPORTED INFORMATION THAT THE DISLODGEMENT WAS NOTED OUT OF PACKAGE. THE BALLOON WAS ALSO FOUND TO BE LOOSELY-FOLDED, WHICH MAY INDICATE THAT POSITIVE PRESSURE MAY HAVE BEEN APPLIED TO THE SYSTEM AT SOME POINT. HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT AN INDEFLATOR MAY HAVE BEEN CONNECTED TO THE VISION DURING PREPARATION, BUT IT WAS NOT INFLATED. THEREFORE, THIS LIKELY OCCURRED DURING HANDLING POST-PROCEDURE. THE ANALYSIS CONFIRMED THAT THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON; HOWEVER, THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. FURTHERMORE, MEASUREMENTS OF THE OUTER DIAMETER OF THE STENT WERE TAKEN AND ALL DIMENSIONS MET MANUFACTURING SPECIFICATION. THE PROTECTIVE SHEATH WAS NOT RETURNED FOR ANALYSIS, WHICH MAY HAVE AIDED THE INVESTIGATION. IN THIS CASE, IT IS POSSIBLE THAT SIGNIFICANT PRESSURE WAS INADVERTENTLY APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH, SUCH THAT THE STENT BECAME DISRUPTED ON THE BALLOON AND DISLODGED AS A RESULT, ALTHOUGH THIS COULD NOT BE CONFIRMED. 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 SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING DEFICIENCY, 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 ALSO SUBJECT TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, WHICH WAS MILDLY TORTUOUS, MODERATELY CALCIFIED, AN ECCENTRIC LESION, DE NOVO, WITH A 100% STENOSIS. THE TARGET VESSEL DIAMETER IS 3.5 MM AND THE TARGET VESSEL LENGTH IS 15 MM. THE PATIENT WAS AN ACUTE MYOCARDIAL INFARCTION PATIENT. DURING PREPARATION FOR INTERVENTION, THE PHYSICIAN PULLED THE 3.5 X 18 MM VISION FROM THE DISPENSER, AND FOUND THAT THE STENT IMPLANT WAS MISSING. THE STENT IMPLANT AND THE STYLET WERE FOUND INSIDE THE PROTECTIVE SHEATH. A 3.5 X 18 MM NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USED ON THE PATIENT. 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 1032341

    Patients

    Seq Age Sex Outcome Treatment
    1