BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1185999 · Received October 2, 2008

    Report

    Report Number
    2024168-2008-00869
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE XIENCE V 2.75 X 28 ( LOT #8021941) IS BEING FILED UNDER MFR # 2024168-2008-00865. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH NO BLOOD OR CONTRAST VISIBLE. THERE WERE CRIMP MARKS ON THE BALLOON AND BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE THREE KINKS IN THE HYPOTUBE, 16 CM, 21 CM, AND 41 CM DISTAL TO THE STRAIN RELIEF TUBING. THE PROTECTIVE SHEATH WAS NOT RETURNED. THERE WAS NO OTHER DAMAGE NOTED TO SDS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE 2.75 X 18 MM XIENCE V STENT IMPLANT DISLODGED IN THE CORONARY AND WAS DEPLOYED AT AN UNINTENDED SITE. ANALYSIS OF THE STENT DELIVERY SYSTEM (SDS) CONFIRMED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT IMPLANT. STENT RETENTION (DISLODGEMENT) CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. IN THIS INSTANCE, CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MFR. THE PT ANATOMY WAS DESCRIBED AS MILDLY TORTUOUS, WHICH MAY HAVE CONTRIBUTED TO THE DISLODGEMENT AND THUS THE CIRCUMSTANCES OF THE PROCEDURE. TO HELP ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A MFG ISSUE, ALL STENT DELIVERY SYSTEM ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES ISSUED FOR THE LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, THERE HAVE BEEN NO OTHER INCIDENTS REGARDING STENT RETENTION REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE. THREE KINKS WERE ALSO NOTED IN THE HYPOTUBE, WHICH WERE NOT OBSERVED DURING THE INSPECTION PRIOR TO USE. THESE KINKS MAY HAVE OCCURRED DURING THE PROCEDURE OR AS A RESULT OF THE HANDLING DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVAL, HOWEVER, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. 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. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS-INJURY PERMANENT DAMAGE. REPORTING RATIONALE: STENT REMAINS IN PT AT AN UNINTENDED SITE. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT AN ATTEMPT WAS BEING MADE TO IMPLANT A XIENCE V 2.75 X 28, HOWEVER, UPON APPROACHING THE LESION, THE STENT DISLODGED. THIS STENT WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. A XIENCE V 2.75 X 18 WAS THEN INSERTED; HOWEVER, IT ALSO MIGRATED (DISLODGED) AND WAS DEPLOYED DISTAL TO THE LESION. FINALLY, A XIENCE V 3.0 X 23 WAS USED AND SUCCESSFULLY CROSSED THE LESION AND WAS IMPLANTED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8030641

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability XIENCE V 2.75 X 28 (LOT # 8021941)| XIENCE V 3.0 X 23