BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2113738 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03877
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, CONSISTENT WITH THE STENT DELIVERY SYSTEM (SDS) ADVANCED OVER A GUIDE WIRE. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BUT NOT BETWEEN THE MARKERS, THE INNER MEMBER WAS BUNCHED AND THE DISTAL BALLOON MARKER WAS NOT LOCATED IN ITS ORIGINAL POSITION. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON SEPARATED FROM THE OUTER MEMBER AT THE PROXIMAL BALLOON SEAL. THE MATERIAL AT THE SEPARATION WAS JAGGED WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THE INNER MEMBER SEPARATED IN TWO SECTIONS, CONFIRMING THE REPORTED SEPARATION. THE FIRST SECTION WAS SEPARATED 9.8CM PROXIMAL TO THE PROXIMAL BALLOON SEAL. THE SECOND SECTION SEPARATED 9MM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE MATERIAL AT BOTH SEPARATIONS WAS JAGGED. THE INNER MEMBER WAS BUNCHED 1MM DISTAL TO THE DISTAL BALLOON MARKER AND EXTENDING PROXIMALLY, FOR AN OVERALL LENGTH OF 4.5 MM. THE TIP WAS BUNCHED DISTAL FROM THE CLEAR GAP, FOR A LENGTH OF 1 MM. THERE WERE THREE KINKS IN THE INNER MEMBER 8.2 CM, 9 CM AND 9.5 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/RETRACT THE SDS OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. THE INNER DIAMETER OF THE GUIDE WIRE EXIT NOTCH WAS MEASURED AND MET MANUFACTURING CRITERIA. AN ATTEMPT WAS MADE TO MEASURE THE INNER DIAMETER OF THE TIP; HOWEVER THE PIN GAUGE COULD NOT ADVANCE PAST THE BUNCHED TIP. THE GUIDE WIRE USED IN THE PROCEDURE WAS NOT RETURNED FOR ANALYSIS THEREFORE IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS POSSIBLE THAT THE COAGULATION OF BLOOD ON THE GUIDE WIRE CONTRIBUTED TO THE REPORTED DIFFICULTIES AS THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE AND THERE WAS NO RESISTANCE REPORTED DURING REMOVAL OF THE STYLET, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE NOTED INNER MEMBER AND SHAFT BUNCHING. FURTHER HANDLING IN THE ATTEMPTS TO REMOVE THE GUIDE WIRE AS FORCE WAS APPLIED LIKELY CONTRIBUTED TO THE SHAFT SEPARATING. ADDITIONAL HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE NOTED SHAFT KINKS. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION/REMOVE THE GUIDE WIRE OR SHAFT SEPARATIONS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY ADVANCING THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE DIFFICULTY REMOVING THE GUIDE WIRE, SHAFT SEPARATION AND NOTED DAMAGE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    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 WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF THE MINI VISION OVER A 0.014 GUIDE WIRE, PRIOR TO ENTERING THE PATIENT, THE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE RE-POSITIONED ON THE GUIDE WIRE. RESISTANCE WAS ENCOUNTERED AND IT BECAME STUCK ON THE GUIDE WIRE AND THE SHAFT OF THE SDS SUBSEQUENTLY SEPARATED INTO 3 PIECES, WHILE STILL OUTSIDE THE PATIENT ANATOMY. NO PATIENT EFFECTS WERE 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 9022041

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR GUIDE WIRE: PT 0.014 BOSTON