BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2080772 · Received May 6, 2011

    Report

    Report Number
    2024168-2011-03268
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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 PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN, SUGGESTING THE SDS HAD BEEN ADVANCED ONTO A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETER DIMENSIONS MET MANUFACTURING CRITERIA. ADDITIONALLY, THE DISTAL EDGE OF THE SOFT TIP WAS JAGGED AND THREE KINKS WERE NOTED IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE DAMAGED TIP AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE FIRST TWO ROWS OF THE PROXIMAL END OF THE STENT IMPLANT WERE MANGLED. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. THE LESION CONDITION WAS DESCRIBED AS MODERATELY TORTUOUS AND CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. ADDITIONALLY, DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE PRODUCT. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE STENT IMPLANT PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED STENT DAMAGE. ANALYSIS NOTED THERE WAS THERE WAS PEELING IN THE BALLOON ON THE PROXIMAL AND DISTAL BALLOON TAPERS, WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFORMATION. THE BALLOON PEELING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE FAILED ATTEMPT TO CROSS THE LESION. IT IS POSSIBLE THAT THE BALLOON MAY HAVE SCRAPED AGAINST THE CALCIFIED LESION, WHICH MAY HAVE CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE REPORTED THE FAILURE TO CROSS, STENT DAMAGE, AND SUBSEQUENT DAMAGE NOTED DURING PRODUCT ANALYSIS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS (SDS) ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE AND BALLOON SHREDDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINI VISION 2.5 X 23 MM STENT WOULD NOT CROSS THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY (RCA) LESION BECAUSE OF RESISTANCE WITH THE ANATOMY. THE MINI VISION WAS NOTED TO BE FLARED. ANOTHER MINI VISION STENT CROSSED THE LESION AND THE PROCEDURE WAS SUCCESSFUL. REPORTEDLY, THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS BEING REPORTED BASED ON THE RETURNED DEVICE ANALYSIS WHICH NOTED BALLOON MATERIAL PEELING.

    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 9113041

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE:RUNTHROUGHGUIDE CATH:HEARTRAIL II JR4