BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1150010 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00727
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE- QUALITY ENGINEERING WAS UNABLE TO UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND STENT IMPLANT. THERE WAS CONTRAST VISIBLE IN THE BALLOON AND INFLATION LUMEN. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE SDS. THE FIRST SEVEN ROWS OF PROXIMAL STRUTS WERE SLIGHTLY SMASHED. THERE WAS A BEND IN THE STENT IMPLANT BETWEEN ROWS NINE AND TEN. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A KINK IN THE HYPOTUBE 5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE MIDDLE AND DISTAL MEASUREMENTS MET MANUFACTURING CRITERIA. THE PROXIMAL MEASUREMENTS COULD NOT BE TAKEN DUE TO THE DAMAGED STRUTS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED DEVICE. STENT RETENTION (DISLODGEMENT) CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION AND/OR ACCESSORY DEVICES. THE PROTECTIVE SHEATH WAS NOT RETURNED FOR EVALUATION, WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. ANALYSIS NOTED EVIDENCE OF DEVICE PREPARATION AND USAGE, AS REPORTED. IT WAS CONFIRMED THAT THE STENT IMPLANT HAD DISLODGED FROM THE BALLOON, ALTHOUGH CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. STENT OUTER DIAMETER IS VERIFIED 100% AT THE TIME OF MANUFACTURE, AND UNITS IN THIS LOT WERE ALL WELL WITHIN THE REQUIRED SPECIFICATION. ALSO, ALL ONLINE TESTING FOR THE LOT IN QUESTION MET STENT IMPLANT SECURITY CRITERIA, WHICH WOULD INDICATE THE UNIT HAD AN ADEQUATE CRIMP. THE DIMENSIONAL ANALYSIS OF THE DEVICE FOUND THAT THE TIP SEAL LENGTH AND THE DISTAL, AND MID OUTER DIAMETERS OF THE STENT IMPLANT MET MANUFACTURING CRITERIA. HOWEVER, THE PROXIMAL END OF THE STENT WAS FOUND TO HAVE SEVERAL ROWS OF DAMAGED STRUTS AND HENCE THE PROXIMAL STENT OUTER DIAMETER DIMENSION WAS UNABLE TO BE MEASURED. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE TIP OF THE GUIDING CATHETER AND/OR RHV DURING RETRACTION OF THE DEVICE. HOWEVER, SINCE THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR USE, IT MAY HAVE OCCURRED FROM HANDLING/ WIPING OF THE DEVICE OR DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION, ALTHOUGH THIS CANNOT BE CONFIRMED. A BEND IN THE STENT IMPLANT AND A KINK IN THE HYPOTUBE WERE ALSO NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE, SUGGESTING THAT THEY ARE A RESULT OF INTERACTIONS WITH OTHER DEVICES, THE PATIENT ANATOMY, OR DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR. IN THIS CASE, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE STENT DISLODGEMENT, HOWEVER, THERE ARE NO INDICATIONS OF A PRODUCT QUALITY ISSUE. 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: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS OCCURRED IN PATIENT ANATOMY AND CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORT THAT THE STENT DISLODGED EITHER DURING THE INITIAL PREP OR WHEN THE PHYSICIAN WIPED DOWN THE DEVICE FOR INSERTION INTO THE PATIENT AGAIN. THE PROCEDURE STARTED WITH THE USE OF A FILTER WIRE AND THE XIENCE WAS ADVANCED OVER THE WIRE, BUT THE WIRE WAS TOO SHORT, SO THE XIENCE WAS REMOVED FROM THE PATIENT AND THE FILTER WIRE WAS REPLACED WITH A PROWATER GUIDE WIRE. IN THE MEANTIME, THE XIENCE DEVICE WAS WIPED DOWN WITH SOME GAUZE FOR INSERTION INTO THE PATIENT AGAIN OVER THE PROWATER GUIDE WIRE. THE XIENCE WAS ADVANCED TO THE LESION AND INFLATED. POSTDILATATION WAS PERFORMED WITH A POWERSAIL BALLOON CATHETER, BUT THE STENT WAS NOT VISIBLE ON FLUORO. AFTER LOOKING AROUND, THE STENT WAS FOUND ON THE PREP TABLE. SO IT IS NOT KNOWN WHEN EXACTLY IT DISLODGED; HOWEVER, IT DID DISLODGE OUTSIDE OF THE PATIENT ANATOMY. THE CASE WAS COMPLETED WITH IMPLANTATION OF THREE XIENCE STENTS, WITH NO FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 7120541

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROWATER| GUIDEWIRE: FILTER WIRE