BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK 8

    MDR report key: 2022721 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01799
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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): NO PRE-DILATATION, AGAINST RESISTANCE. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE IN THE BALLOON AND INFLATION LUMEN, CONSISTENT WITH A SEPARATION WHILE IN THE PATIENT ANATOMY. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED, CONFIRMING THE REPORTED EVENT. 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 SHAFT WAS SEPARATED 4 MM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE MATERIAL AT THE SEPARATION WAS STRETCHED AND JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). THERE WAS A KINK IN THE SHAFT 12.2 CM DISTAL TO THE PROXIMAL BALLOON SEAL. THERE WERE MULTIPLE BENDS THROUGHOUT THE ENTIRE LENGTH OF THE HYPOTUBE. THE TIP LENGTH 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 LESION WAS NOT PRE-DILATED. IT SHOULD BE NOTED THE ML 8 INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE HEAVILY CALCIFIED, NON PRE-DILATED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, IT WAS REPORTED THAT FORCE WAS APPLIED IN THE ATTEMPT TO CROSS THE LESION. THE ML8 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. AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS 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 INTERACTION WITH THE DAMAGED STENT AND THE ANATOMY DURING RETRACTION WOULD HAVE THEN LED TO THE REPORTED RESISTANCE AND CONTRIBUTED TO THE SHAFT SEPARATING AS RESISTANCE WAS ENCOUNTERED. ATTEMPTS WERE MADE TO SNARE THE SEPARATED SHAFT, RESULTING IN THE STENT DISLODGING FROM THE BALLOON. THE SEPARATED SHAFT WAS ABLE TO BE RETRIEVED FROM THE ANATOMY WHICH LIKELY CONTRIBUTED TO THE NOTED KINDS AND BENDS. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL STENT DELIVERY SYSTEMS (SDS) ARE INSPECTED FOR PROPER KINKS, STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE AND LUMEN INTEGRITY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER EVENTS REPORTED FOR THIS LOT. 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 100% 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 DURING THE PROCEDURE IN THE HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA), DIRECT STENTING WAS ATTEMPTED USING A 3.5 X 12 MULTI-LINK 8 STENT SYSTEM VIA RADIAL ARTERY ACCESS. DURING ADVANCEMENT OF THE DELIVERY CATHETER, RESISTANCE WAS FELT DUE TO CALCIFICATION AND FORCE WAS APPLIED. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE CATHETER SO THAT DILATATION COULD BE PERFORMED; HOWEVER, THE DISTAL SHAFT SEPARATED. A LASSO WAS USED TO CAPTURE THE DISTAL SEGMENT OF THE CATHETER. WHILE REMOVING THE DISTAL SEGMENT OF THE CATHETER USING THE LASSO, THE STENT DISLODGED FROM THE BALLOON IN THE VESSEL. THE BALLOON AND THE DISTAL SEGMENT OF THE CATHETER WERE RETRIEVED FROM THE ANATOMY USING THE LASSO. A 3.5 X 18 MULTI-LINK 8 STENT WAS SUCCESSFULLY DEPLOYED IN THE RCA TO EMBED THE DISLODGED STENT TO THE VESSEL WALL. THE LESION IN THE DISTAL RCA WAS NOT TREATED. ALTHOUGH A SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE WAS REPORTED, THE LENGTH OF THE PROCEDURE WAS LESS THAN 30 MINUTES AND THE PATIENT CONDITION IS REPORTED AS GOOD. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0022441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: CORDIS 6F