BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2120415 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04111
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. DILATATION CATHETER: FIRESTAR; GUIDE WIRE: BALANCE MIDDLEWEIGHT; GUIDE CATH: JR 4.0 THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED MULTI-LINK RX VISION STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, CONSISTENT WITH 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 TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING ADVANCEMENT IN THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. SUBSEQUENT MANIPULATION WITHIN THE LESION/ANATOMY WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. ADDITIONAL TREATMENT WAS USED TO REMOVE THE DISLODGED STENT FROM THE PATIENT ANATOMY. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT 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 HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENTS FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR PROPER STENT PLACEMENT AND DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT SUBMITTED, ADDITIONAL INFORMATION RECEIVED STATED, THAT DURING A PROCEDURE OF THE HEAVILY TORTUOUS AND CALCIFIED RESTENOSED RIGHT CORONARY ARTERY (RCA), RESISTANCE WAS MET WHEN ADVANCING THE PRE-DILATATION BALLOON CATHETER PRIOR TO REACHING THE POSTERIOR DESCENDING ARTERY. AT THE OSTIUM OF THE RCA, DURING ADVANCING OF THE 3.5 X 23 MM RX MULTI-LINK VISION TO TREAT A NATIVE LESION IN THE DISTAL PORTION, THE STENT DISLODGED COMPLETELY FROM THE STENT DELIVERY SYSTEM. THE DISLODGED STENT WAS REMOVED USING A LOOP. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PROCEDURE WAS COMPLETED WITHOUT ANY EFFECT TO THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, IN A HEAVILY TORTUOUS VESSEL AND HEAVILY CALCIFIED LESION, THE 3.5 X 23 MM RX MULTI-LINK VISION STENT DISLODGED FROM THE STENT DELIVERY SYSTEM AT THE OSTIUM OF THE RCA. THE TREATMENT AND PATIENT STATUS WAS NOT PROVIDED, BUT HAS BEEN REQUESTED. THERE WAS NO ADDITIONAL INFORMATION 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 0080441

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other