BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2231930 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06097
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX VISION STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, CONSISTENT WITH THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THERE WERE MANGLED STRUTS ON THE FIRST THREE ROWS AT THE DISTAL END OF THE STENT IMPLANT, CONFIRMING THE REPORTED STENT DAMAGE. THERE WERE TWO KINKS IN THE HYPOTUBE 16.8 CM AND 85.3 CM DISTAL TO THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE WITH A GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE STENT, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, DURING MANUFACTURING, ALL SDS ARE 100% CHECKED FOR DAMAGE AND CRIMPED STENT PROFILE. THE PROXIMAL AND MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE DISTAL STENT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. THE GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE SDS WAS ADVANCED THROUGH A NEW 6FR GUIDING CATHETER WITH SLIGHT RESISTANCE AT THE MANGLED STRUTS. IT IS LIKELY THE SDS INTERACTED WITH THE OTHER SDS CATHETER THAT WAS ALREADY INSIDE OF THE GUIDING CATHETER, RESULTING IN THE STENT DAMAGE AS THERE WAS NO DAMAGE NOTED TO THE STENT DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. FURTHER INTERACTION WITH GUIDING CATHETER AND THE DAMAGED STENT WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE DURING RETRACTION. THE ANALYSIS OF THE RETURNED DEVICE DID NOT INDICATE ANY EVIDENCE OF A PRODUCT QUALITY DEFICIENCY. A SEARCH OF THE DEVICE LOT HISTORY RECORD INDICATED NO NONCONFORMANCE FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A NON-ABBOTT STENT WAS FIRST PLACED IN THE CIRCUMFLEX ARTERY, AND THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS KEPT IN THE CIRCUMFLEX. THE 3.5 X 15 MM VISION SDS WAS ADVANCED TOWARD THE TARGET LESION; HOWEVER, RESISTANCE INCREASED AS THE SDS WAS BEING ADVANCED INTO THE GUIDING CATHETER. THE VISION SDS WAS REMOVED, AND SOME RESISTANCE WAS NOTED. IT WAS OBSERVED THAT THE STENT STRUTS WERE FLARED. IT WAS NOTED THAT THE VISION MAY HAVE BEEN DAMAGED ON THE GUIDE WIRE EXIT PORT OF THE NON-ABBOTT SDS. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 9072142

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUE