BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1013294 · Received March 14, 2008

    Report

    Report Number
    2024168-2008-00188
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THERE WAS FLUID VISIBLE IN THE BALLOON. THE STENT IMPLANT WAS RETURNED DISLODGED IN THE PROTECTIVE SHEATH ON THE STYLET. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS LOOSELY FOLDED. THERE WERE SLIGHT CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. A LASER MICROMETER WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS AND THE MEASUREMENTS WERE OVERSIZED. A PIN GAUGE WAS USED TO MEASURE THE INNER DIAMETER OF THE PROTECTIVE SHEATH, AND IT WAS FOUND TO BE WITHIN SPECIFICATION. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND RESULTS OF THE RETURNED DEVICE ANALYSIS. THE ACCOUNT COULD NOT CONFIRM IF THE STENT WAS NOTICED TO BE DISLODGED SOMETIME PRIOR TO USE OR ACTUALLY AT THE MOMENT OF DEPLOYMENT. REPORTEDLY, THE MISSING STENT WAS FOUND DISLODGED IN THE PROTECTIVE SHEATH. ANALYSIS OF THE RETURNED DEVICE DID FIND THE STENT DISLODGED FROM THE BALLOON ON THE STYLET INSIDE THE PROTECTIVE SHEATH, WHICH IS CONSISTENT WITH THE REPORTED DISLODGEMENT OUTSIDE OF THE BODY. HOWEVER, ALTHOUGH NO BLOOD WAS VISIBLE, CONTRAST IN THE INFLATION LUMEN AND FLUID IN THE LOOSELY FOLDED BALLOON SUGGESTS THAT THE DEVICE WAS PREPARED FOR USE AND LIKELY INFLATED OR HAD SOME POSITIVE PRESSURE APPLIED, BUT IT IS ULTIMATELY UNK IF THE SDS ENTERED THE BODY OR IF THE INFLATION/PRESSURIZATION OCCURRED OUTSIDE THE BODY. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE OF THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. ANALYSIS OF THE RETURNED DEVICE INDICATES THE PRESENCE OF SLIGHT CRIMP MARKS ON THE BALLOON THAT WERE BETWEEN THE MARKERS OF THE LOOSELY FOLDED BALLOON. THIS SUGGESTS THAT THE STENT IMPLANT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. THE LOOSELY FOLDED BALLOON COULD BE THE RESULT OF THE PHYSICIAN ATTEMPTING TO DEPLOY THE STENT BEFORE REALIZING THE STENT IMPLANT HAD DISLODGED. BUT IT COULD ALSO INDICATE THAT POSITIVE PRESSURE WAS APPLIED PRIOR TO USE. IF POSITIVE PRESSURE WAS APPLIED TO THE SYSTEM DURING PREPARATION, THIS MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THE INNER DIAMETER OF THE RETURNED PROTECTIVE SHEATH WAS FOUND TO BE WITHIN SPECIFICATION. THE OVER-SIZED OUTER DIAMETERS OF THE STENT IMPLANT NOTED DURING ANALYSIS SUGGEST THAT THE STENT SLIGHTLY EXPANDED DURING TRAVEL OVER THE BALLOON AS IT DISLODGED, AS WOULD BE EXPECTED. BASED ON THE INCIDENT INFO AND RESULTS OF THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED COMPLAINT OF STENT DISLODGEMENT CANNOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST THAT MATERIALS OR WORKMANSHIP MAY HAVE CAUSED OR CONTRIBUTED TO THE ANOMALY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS READY TO DEPLOY THE STENT, IT WAS NOTED THAT THE STENT WAS MISSING. IT IS UNK IF THIS OCCURRED PRIOR TO THE ACTUAL USE OF THE DEVICE OR IF THE DEVICE WAS IN PLACE AT THE TARGET LESION AND READY TO DEPLOY THE STENT. THE DISLODGED STENT WAS LOCATED IN THE PROTECTIVE SHEATH. THERE WERE NO PT EFFECTS REPORTED. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7121231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK