BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1073716 · Received July 1, 2008

    Report

    Report Number
    2024168-2008-00545
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 11, 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
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS -PRODUCT PERFORMANCE GROUP COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS DISLODGED DISTALLY FROM THE BALLOON. THE DISTAL END OF THE STENT IMPLANT WAS .5MM PROXIMAL TO THE DISTAL END OF THE TIP. THERE WERE TWO STRUTS IN THE FIRST ROW OF DISTAL STRUTS THAT WERE BENT BACK TOWARDS THE TIP AND FOUR STRUTS THAT WERE FLARED. THE STENT IMPLANT WAS TIGHTLY CRIMPED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. THE ORANGE PROTECTIVE SHEATH WAS RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE STENT IMPLANT OUTER DIAMETERS, AND THEY DID NOT MEET MANUFACTURING CRITERIA. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH, WHICH MET SPECIFICATION. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS. REPORTEDLY, THERE WAS NO PATIENT INVOLVEMENT. ANALYSIS OF THE RETURNED DEVICE DID FIND THE STENT IMPLANT DISLODGED DISTALLY FROM THE BALLOON WHICH IS CONSISTENT WITH THE REPORTED DISLODGEMENT OUTSIDE THE BODY. SIMILARLY, THERE WAS NO BLOOD OR CONTRAST VISIBLE ON THE RETURNED DEVICE, WHICH CONFIRMS THE REPORTED INFORMATION OF NO PATIENT INVOLVEMENT. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, INCORRECT SHEATH SIZING, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. ANALYSIS OF THE RETURNED DEVICE INDICATES PRESENCE OF CRIMP MARKS ON THE BALLOON THAT WERE BETWEEN THE MARKERS OF THE STILL TIGHTLY FOLDED BALLOON, SUGGESTING THAT THE STENT IMPLANT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. IT WAS REPORTED THAT THE STENT WAS FOUND LOOSE INSIDE THE BOX WHEN THE PACKAGE WAS OPENED. HOWEVER, THE RETURNED STENT IMPLANT WAS FOUND DISLODGED DISTALLY FROM THE BALLOON. IT IS POSSIBLE THAT THE PROTECTIVE SHEATH MAY HAVE BEEN FORCEFULLY REMOVED THEREBY CAUSING/CONTRIBUTING TO THE MOVEMENT OF THE STENT DISTALLY ON THE BALLOON. IT IS ALSO POSSIBLE THAT THE STENT WAS REMOUNTED ON THE BALLOON AFTER THE REPORTED DISLODGEMENT. THE NOTED DAMAGE AT THE DISTAL END OF THE STENT IMPLANT MAY HAVE OCCURRED DURING THE REMOVAL OF THE PROTECTIVE SHEATH OR IT MAY HAVE OCCURRED DURING HANDLING OF THE STENT AFTER THE DISLODGEMENT. THE INNER DIAMETER OF THE RETURNED PROTECTIVE SHEATH WAS FOUND TO BE WITHIN SPECIFICATION. THE OVER-SIZED OUTER DIAMETERS (OD) OF THE STENT IMPLANTED NOTED DURING ANALYSIS SUGGEST THAT THE STENT SLIGHTLY EXPANDED DURING TRAVEL OVER THE BALLOON AS IT DISLODGED, AS WOULD BE EXPECTED. HOWEVER, CRIMPED STENT OD IS CHECKED ON-LINE TO ENSURE PROPER DIMENSIONS AT THE TIME OF MANUFACTURING. BASED ON THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED STENT DISLODGEMENT. HOWEVER, THERE IS NO INDICATION OF A QUALITY ISSUE. THE LOT HISTORY RECORD REVIEW DID NOT INDICATE ANY NON-CONFORMING MATERIAL REPORTS. AS A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED, AND THERE IS NO INDICATION OF A QUALITY ISSUE, NO CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVER 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 TO BE CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED THE STENT WAS LOOSE IN THE BOX. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74 MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8022631

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR