BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 1890991 · Received October 29, 2010

    Report

    Report Number
    2024168-2010-02285
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). POSSIBLE CAUSES FOR DIFFICULTY IN REMOVING A STENT DELIVERY SYSTEM (SDS) AFTER STENT DEPLOYMENT MAY INCLUDE: INTERACTION OF THE BALLOON WITH A STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED TO THE VESSEL WALL, THE BALLOON NOT BEING FULLY DEFLATED PRIOR TO ATTEMPTING TO REMOVE THE BALLOON FROM THE IMPLANTED STENT, DAMAGE TO THE BALLOON, KINKS, BENDS, OBSTRUCTIONS IN THE GUIDING CATHETER LUMEN, OR DAMAGE TO THE GUIDING CATHETER. RETURN OF THE ML8 SDS AND GUIDING CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE EVALUATION AND DETERMINATION OF CAUSE. IT WAS REPORTED THE SDS MET RESISTANCE DURING RETRACTION AND FORCE WAS APPLIED AND THE SDS WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. IT SHOULD BE NOTED IN THE MULTI LINK 8 INSTRUCTIONS FOR USE (IFU) IT STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. IT WAS REPORTED THE PHYSICIAN COMMENTED THAT THE DIFFICULTY REMOVING THE SDS POST DEPLOYMENT DUE TO AN INTERACTION WITH THE GUIDE CATHETER COULD POSSIBLY LEAD TO A DISSECTION. DISSECTIONS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). HOWEVER DISSECTIONS ARE NOT NECESSARILY ASSOCIATED WITH THE HAZARD OF DIFFICULTY REMOVING THE SDS POST DEPLOYMENT OF THE STENT. ADDITIONALLY, AS THE PHYSICIAN ONLY COMMENTED THAT HE THOUGHT THE REPORTED DIFFICULTIES COULD LEAD TO A DISSECTION, ONE DID NOT OCCUR IN THIS CASE. 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 COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTY REMOVING THE SDS CANNOT BE DETERMINED. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE.

    Additional Manufacturer Narrative · 1

    (B)(4) (AGAINST RESISTANCE). (B)(4). THE STENT REMAINS IN THE PT. THE STENT DELIVERY SYSTEM WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MID LEFT ANTERIOR DESCENDING ARTERY, THE MULTI-LINK 8 STENT WAS SUCCESSFULLY DEPLOYED. AN ATTEMPT WAS MADE TO WITHDRAW THE STENT SYS FROM THE ANATOMY; HOWEVER, RESISTANCE WAS FELT AND IT WAS NOTED THAT THE BALLOON WAS CAUGHT ON THE NON-ABBOTT GUIDING CATHETER IN THE LEFT MAIN ARTERY. FORCE WAS APPLIED AND THE STENT SYS WAS SUCCESSFULLY REMOVED FROM THE ANATOMY. REPORTEDLY, THE BALLOON WAS DEFLATED. THE PHYSICIAN STATED THAT THIS TYPE OF DEVICE ISSUE COULD CAUSE A DISSECTION. A DISSECTION DID NOT OCCUR IN THIS PROCEDURE. THOUGH REQUESTED, ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 0012541

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT UII| GUIDE CATH: EBU 6F LAUNCHER