BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1344238 · Received March 13, 2009

    Report

    Report Number
    2024168-2009-00411
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 18, 2009
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY - QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITHOUT ANY BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON HAD RELAXED FOLDS. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE HYPOTUBE AND JACKET WERE SEPARATED AT THE DISTAL END OF THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED, AS IF THE HYPOTUBE WAS KINKED PRIOR TO SEPARATING. THE MATERIAL WAS JAGGED AND STRETCHED AT THE SEPARATION. THERE WAS A KINK IN THE HYPOTUBE 67 CM DISTAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: PARTIALLY DEPLOYED STENT REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: PARTIAL STENT DEPLOYMENT/DIFFICULT TO REMOVE/SHAFT SEPARATION. IT WAS REPORTED THAT AFTER IMPLANTING THREE XIENCE STENTS IN THE LEFT ANTERIOR DESCENDING (LAD), THE 3.5 X 15 MM XIENCE V WAS SELECTED FOR USE IN THE RIGHT DIAGONAL, USING THE CULOTTE TECHNIQUE. A "LIGHT" DEFORMATION OF THE SHAFT WAS NOTICED, IMMEDIATELY AFTER THE HUB; HOWEVER, IT WAS DECIDED THAT THIS IS NOT REALLY BAD DAMAGE, BECAUSE THIS HAPPENED RELATIVELY OFTEN. SO, THE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND INFLATED TO 14 BAR. BUT THE SDS SHAFT BROKE INTO TWO PIECES AT APPROX 4 ATM, AND THE STENT WAS "A LITTLE BIT" IMPLANTED WITH VERY LOW PRESSURE. THE DECISION WAS MADE TO TRY TO CATCH THE STENT WITH A SNARE INTO THE GUIDING CATHETER, BUT THE STENT WAS CAUGHT IN A PREVIOUSLY PLACED STENT IN THE LAD AND THE 3.5 X 15 MM STENT WAS COMPLETELY DEFORMED FOR A LENGTH OF APPROXIMATELY 4 CM UP TO THE LEFT MAIN/AORTA. THE PT WAS SENT TO SURGERY FOR BOTH CABG AND REMOVAL OF THE STENT. THE SURGEON COULD NOT REMOVE THE STENT COMPLETELY - SO MOST OF THE STENT WAS CUT OUT. SUCCESSFUL OPERATION. PT NOW IN GOOD CONDITION. NO ADDITIONAL EVENT OR PT 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 8091541

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R| S DIL CATH: MAVERICK 2| PILOT 50/150 BMW UNIVERSAL| STENT: 3.5 X 18MM| 3.0 X 23 MM| 2.5 X 18 MM XIENCE| GUIDE CATH: LAUNCHER EBU 3.5