BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2153709 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04822
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MINI VISION STENT DELIVERY SYSTEM (SDS) NOTED THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY-FOLDED BALLOON BETWEEN THE MARKERS. THE PROXIMAL END OF THE STENT IMPLANT WAS MANGLED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE GUIDING CATHETER USED DURING THE PROCEDURE WAS NOT RETURNED. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ANALYSIS OF THE RETURNED PRODUCT FOUND THE MIDDLE AND DISTAL CRIMPED STENT OUTER DIAMETERS MET MANUFACTURING SPECIFICATION. THE PROXIMAL OUTER DIAMETER COULD NOT BE MEASURED DUE TO THE NOTED DAMAGE. IN THIS CASE, THE ONLY TIME RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE MINI VISION WAS REPORTEDLY WHEN THE SDS REACHED THE MID SEGMENT OF THE RCA; THEREFORE, THE TORTUOUS AND CALCIFIED ANATOMY LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. AS THERE WAS NO REPORTED STENT DAMAGE PRIOR TO USE, THE STENT DAMAGE LIKELY OCCURRED DURING USE. THE OBSERVED DAMAGE AT THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH RESISTANCE OR INTERACTION WITH THE LESION OR ACCESSORY DEVICES DURING RETRACTION. AS THE GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED, THE RETURNED SDS WAS USED IN ATTEMPT TO ADVANCE THROUGH A NEW 6F GUIDING CATHETER, BUT THE SDS WOULD NOT ADVANCE PAST THE MANGLED STRUTS OF THE PROXIMAL END OF THE STENT IMPLANT. IT IS LIKELY THAT THE STENT WAS NOT ALIGNED COAXIALLY WITH THE GUIDING CATHETER AND INTERACTED WITH DISTAL TIP OF THE GUIDING CATHETER, RESULTING IN THE PROXIMAL STENT DAMAGE AND RESISTANCE DURING REMOVAL. DURING MANUFACTURING, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE AND CHECKED FOR PROPER CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING PROPER GUIDE WIRE LUMEN MOVEMENT AND CRIMPED STENT PROFILE. A REVIEW OF THE FINISHED GOOD LOT HISTORY RECORD REVEALED NO NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT, AND ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FOR STENT DAMAGE OR DIFFICULT TO REMOVE FROM GUIDING CATHETER. THE REPORTED EVENT APPEARS TO RELATED TO OPERATIONAL CONTEXT AND THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINI VISION WAS UNABLE TO CROSS THE MID SEGMENT OF THE PRE-DILATED TARGET LESION IN THE TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY. RESISTANCE WAS FELT DURING REMOVAL OF THE MINI VISION FROM THE NON-ABBOTT GUIDING CATHETER. AFTER REMOVAL OF THE MINI VISION FROM THE PATIENT, THERE WERE FLARED STENT STRUTS NOTED ON THE PROXIMAL END OF THE MINI VISION. THE PHYSICIAN BELIEVES THAT THIS DAMAGE WAS CAUSED BY THE 6 FRENCH NON-ABBOTT GUIDING CATHETER. A NON-ABBOTT STENT WAS ABLE TO CROSS THE LESION TO COMPLETE THE PROCEDURE. AN NC TREK ALSO CROSSED FOR POST-DILATATION OF THE NON-ABBOTT STENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1021041

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR GUIDE CATHETER: MEDTRONIC LAUNCHER 6F JR 4