BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2048937 · Received April 11, 2011

    Report

    Report Number
    2024168-2011-02535
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION. THE STENT IMPLANT WAS DISLODGED FROM THE SDS, CONFIRMING THE REPORTED INFORMATION. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE INNER AND OUTER MEMBERS WERE SEPARATED AT THE PROXIMAL BALLOON SEAL. THE DISTAL PORTION WAS RETURNED FROZEN ON THE PROXIMAL END OF THE GUIDE WIRE USED DURING THE PROCEDURE. THE DISTAL END OF THE SOFT TIP WAS 6CM DISTAL TO THE PROXIMAL END OF THE GUIDE WIRE. THE MIDDLE OF THE OUTER MEMBER WAS BUNCHED FOR A LENGTH OF 3 MM AND 1 CM. THE INNER MEMBER WAS BUNCHED FOR A LENGTH OF 1MM DISTAL TO THE DISTAL MARKER AND 4 MM PROXIMAL TO IT. THE GUIDE WIRE WAS RETURNED WITHOUT ANY BLOOD OR CONTRAST VISIBLE. THERE WAS A BEND IN THE CORE 2.5 CM PROXIMAL TO THE TIPBALL. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE THE SDS OVER THE GUIDE WIRE MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, 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. THE INNER DIAMETER OF THE INNER MEMBER COULD NOT BE TAKEN DUE TO THE DAMAGE NOTED. THE OUTER DIAMETER OF THE CORE OF THE GUIDE WIRE WAS MEASURED AND MET MANUFACTURING CRITERIA. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SEPARATE THE RETURNED SDS AND GUIDE WIRE. THE RETURNED SDS COULD NOT BE USED FOR FUNCTIONAL TESTING DUE TO THE DAMAGE. THE RETURNED GUIDE WIRE WAS FRONT LOADED AND ADVANCED THROUGH A NEW SDS WITH NO RESISTANCE NOTED. THE PROXIMAL STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE MIDDLE AND DISTAL OUTER DIAMETERS WERE OUTSIDE OF THE ACCEPTED MANUFACTURING SPECIFICATION HOWEVER, BECAUSE STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE AND UNITS IN THIS LOT WERE ALL WITHIN THE REQUIRED SPECIFICATION. THIS OVER-SIZING MOST LIKELY OCCURRED AT THE TIME OF DISLODGEMENT AS IT IS EXPECTED THAT THE STENT WOULD EXPAND DURING TRAVEL OVER THE BALLOON SHOULDERS. IT IS LIKELY THAT AS RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE SDS ON THE GUIDE WIRE, EXCESSIVE FORCE WAS APPLIED TO THE CATHETER, RESULTING IN THE SHAFT BUNCHING. FURTHER HANDLING DURING THE ATTEMPT TO REMOVE THE SDS FROM THE GUIDE WIRE LIKELY RESULTED IN FURTHER DAMAGING THE SHAFT, THE STENT DISLODGING, AND THE SHAFT ULTIMATELY SEPARATING. IT SHOULD BE NOTED THE MINI VISION INSTRUCTIONS FOR USE (IFU) STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. HOWEVER, IN THIS CASE, THE INITIAL CAUSE OF THE RESISTANCE WITH THE GUIDE WIRE COULD NOT BE DETERMINED. 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 HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION/REMOVE THE GUIDE WIRE, SHAFT SEPARATION, SHAFT BUNCHING, OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES WITH THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE SHAFT SEPARATION AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE CIRCUMFLEX ARTERY, AN ATTEMPT WAS MADE TO INSERT A 2.5 X 23 MINI VISION STENT SYSTEM OVER A WHISPER MS J GUIDE WIRE OUTSIDE OF THE ANATOMY. THE STENT SYSTEM BECAME STUCK ON THE GUIDE WIRE. AN ATTEMPT WAS MADE TO REMOVE THE STENT SYSTEM FROM THE GUIDE WIRE; HOWEVER, RESISTANCE WAS FELT. FORCE WAS APPLIED, THE BALLOON SEPARATED FROM THE CATHETER, AND THE STENT DISLODGED FROM THE BALLOON. A NEW 2.5 X 23 MINI VISION STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0120941

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GUIDE WIRE: WHISPER MS J