BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2231989 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06101
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. EVALUATION SUMMARY: ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST IN THE BALLOON AND INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED, CONFIRMING THE REPORTED DISLODGEMENT. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE ENTIRE LENGTH OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. 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, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE HEAVILY CALCIFIED LESION WAS NOT PRE-DILATED PRIOR TO ADVANCING THE MINI VISION SDS, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE MINI VISION INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER. ADDITIONALLY, IT WAS REPORTED THE SDS WAS ADVANCED AS RESISTANCE WAS ENCOUNTERED AND FORCE WAS APPLIED, WHICH MAY HAVE CONTRIBUTED TO DAMAGING THE STENT. THE IFU WARNS: 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. IT IS LIKELY THAT THE STENT INTERACTED WITH THE HEAVILY CALCIFIED LESION DURING RETRACTION, CONTRIBUTING TO DAMAGING THE STENT RESULTING IN RESISTANCE DURING RETRACTION AND THE STENT ULTIMATELY DISLODGING. THE DISLODGED STENT WAS UNABLE TO BE LOCATED AND MAY REMAIN IN THE PATIENT ANATOMY AND RESULTED IN A DELAY IN THE PROCEDURE. TO HELP ENSURE THE REPORTED DIFFICULTIES ARE NOT RELATED TO A MANUFACTURING DEFICIENCY, THE BALLOON IS CHECKED FOR PROPER FOLD CONFIGURATION, THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE STENT IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR STENT DAMAGE DURING THE MANUFACTURING PROCESS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR DIFFICULT TO REMOVE OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY, A NON-ABBOTT GUIDE CATHETER WAS INSERTED INTO THE PATIENT ANATOMY. NO PRE-DILATATION WAS PERFORMED BEFORE A 2.0 X 15 MM MINI VISION RX STENT SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY. THE STENT SYSTEM WAS ADVANCED WITH SOME RESISTANCE AND MODERATE FORCE WAS APPLIED; HOWEVER, THE STENT SYSTEM WOULD NOT CROSS THE LESION. DURING WITHDRAWAL AS A SINGLE UNIT, AS THE STENT SYSTEM WAS BEING PULLED THROUGH THE GUIDE CATHETER, RESISTANCE WAS FELT AND THE MINI VISION STENT WAS DISLODGED AND CAME OFF THE BALLOON. COMPUTERIZED TOMOGRAPHY WAS PERFORMED AND THE STENT WAS NOT SEEN IN THE PATIENT'S HEAD OR CHEST; HOWEVER, IT IS UNKNOWN WHERE THE STENT IS AT THIS TIME AND NO FURTHER INTERVENTION WAS PERFORMED TO RETRIEVE THE STENT. A 2.25 X 18 PROMUS STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY AND NO OTHER ADVERSE PATIENT SEQUELAE. 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 1042841

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other GUIDE CATH: MEDTRONIC