BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2032734 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02109
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. (B)(4) - DISTAL TO STENT/RE-INSERTION. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMICAL CONDITIONS WERE NOT REPORTED WHICH MAY HAVE AIDED IN THE INVESTIGATION; HOWEVER, IT WAS REPORTED THAT TWO STENTS WERE DEPLOYED AND THE STENT DELIVERY SYSTEM (SDS) WAS RE-INSERTED INTO THE PATIENT ANATOMY AFTER THE FAILED ATTEMPT TO CROSS, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE MINI VISION INSTRUCTIONS FOR USE (IFU) STATES, AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. ADDITIONALLY, THE IFU WARNS, WHEN TREATING MULTIPLE LESIONS, STENT THE DISTAL LESION PRIOR TO STENTING THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT, AND REDUCES THE CHANCE OF DISLODGING THE PROXIMAL STENT. AN INTERACTION WITH THE DEPLOYED STENTS DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE TO THE STENT AND SUBSEQUENTLY LEAD TO THE STENT DISLODGEMENT. 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. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.0 X 8 MINI VISION WAS ADVANCED; HOWEVER, DUE TO UNSPECIFIED ANATOMICAL CONDITIONS, THE STENT WOULD NOT CROSS THE LESION. TWO NON-ABBOTT STENTS WERE IMPLANTED IN THE PROXIMAL TO MID RCA TO OPEN THE VESSEL. THE 2.0 X 8 MINI VISION WAS RE-INSERTED IN AN ATTEMPT TO TREAT THE DISTAL RCA; HOWEVER, THE DEVICE BECAME STUCK IN THE SAME AREA, ON ONE OF THE PREVIOUSLY IMPLANTED STENTS. THE MINI VISION WAS REMOVED WITHOUT RESISTANCE, AND NO DAMAGE WAS NOTED TO THE PREVIOUSLY IMPLANTED STENT. AFTER REMOVAL, IT WAS OBSERVED UNDER FLUOROSCOPY, THAT THE STENT DISLODGED IN THE MID RCA. A 1.5 BALLOON WAS USED TO PULL THE STENT BACK PROXIMAL TO THE IMPLANTED STENTS, AND A 2.5 BALLOON WAS USED TO OPPOSE THE STENT INTO THE PROXIMAL RCA. A NON-ABBOTT DRUG-ELUTING STENT (DES) WAS PLACED OVERLAPPING THE 2.0 X 8 MINI VISION, AS THE PHYSICIAN COMMENTED THAT HE WANTED A DES TO COVER THE HEALTHY TISSUE. THE VESSEL WAS LEFT AT STENTING IN THE PROXIMAL TO MID RCA, WITH NO FURTHER TREATMENT. THERE WERE NO 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 0101441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention