BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2052320 · Received April 12, 2011

    Report

    Report Number
    2024168-2011-02579
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE STENT IMPLANT WAS RETURNED WITH BLOOD ON THE STRUTS AND NO CONTRAST VISIBLE. THE STENT IMPLANT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) AND WAS RETURNED ENTANGLED TO A SNARE DEVICE. THE SDS WAS NOT RETURNED. THE ENTIRE LENGTH OF THE STENT IMPLANT WAS STRETCHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE PROTECTIVE SHEATH WAS NOT RETURNED. A NON-ABBOTT GUIDING CATHETER WAS RETURNED WITH BLOOD IN AND ON THE SHAFT AND NO CONTRAST VISIBLE. THERE WAS NO DAMAGE NOTED TO THE RETURNED NON-ABBOTT GUIDING CATHETER. A MICRO CATHETER WAS RETURNED WITH BLOOD IN AND ON THE SHAFT AND NO CONTRAST VISIBLE. THERE WAS NO DAMAGE NOTED TO THE RETURNED MICRO CATHETER. THIS IS ALL CONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT DISLODGED AND WAS RETRIEVED USING A MICRO CATHETER. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE SDS WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION; HOWEVER, THE ANATOMICAL CONDITIONS REPORTED WERE MILD TORTUOUSITY AND CALCIFICATION WHICH APPEARS TO HAVE CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. DURING REMOVAL OF THE SDS, THERE WAS RESISTANCE (DIFFICULT TO REMOVE) AND SUBSEQUENTLY LED TO THE REPORTED STENT DISLODGED. A MICRO-CATHETER WAS ADVANCED AND SUCCESSFULLY RETRIEVED THE STENT (ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT AND REMOVAL OF FOREIGN BODY). ANALYSIS NOTED THE STENT WAS RETURNED ENTANGLED AND STRETCHED ON THE SNARE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT WAS SUCCESSFULLY RETRIEVED. THE ANATOMICAL CONDITIONS APPEAR TO ALSO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY TO REMOVE WHICH RESULTED IN THE STENT DISLODGEMENT. ADDITIONALLY, IT WAS REPORTED THAT THE LEFT POSTERIOR DESCENDING LESION WAS NOT PRE-DILATED. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. IT DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE INCIDENT AS THE STENT WAS REPORTED TO HAVE BEEN STUCK IN THE DISTAL CIRCUMFLEX (CX) AND THE SDS NEVER MADE IT TO THE LEFT POSTERIOR DESCENDING LESION WHICH IS FURTHER DISTAL. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMRS) ISSUED FOR THIS LOT. THE REPORTED FAILURE TO CROSS, STENT DISLODGEMENT, DIFFICULTY TO REMOVE, FOREIGN BODY REMOVAL AND ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE PRIOR TO RELEASE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT POSTERIOR DESCENDING ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. A 2.75 X 28 XIENCE WAS DEPLOYED IN THE OBTUSE MARGINAL, AND DIRECT-STENTING WAS ATTEMPTED WITH THE 2.5 X 23 XIENCE IN THE LEFT POSTERIOR DESCENDING ARTERY; HOWEVER, DURING ADVANCEMENT, THE STENT DELIVERY SYSTEM (SDS) BECAME STUCK IN THE DISTAL CIRCUMFLEX (CX), AND WOULD NOT ADVANCE FURTHER. AN ATTEMPT WAS MADE TO WITHDRAW THE SDS; HOWEVER, RESISTANCE WAS NOTED, AND THE STENT DISLODGED, REMAINING IN THE PROXIMAL CX TO THE AORTA. IT IS NOT CLEAR WHAT CAUSED THE RESISTANCE. THE STENT WAS RETRIEVED WITH A NON-ABBOTT CATHETER, AND MICRO-CATHETER. THE PROCEDURE WAS CLOSED AS 75% STENOSIS REMAINING, AND THE PATIENT WILL HAVE FURTHER TREATMENT OF THE VESSEL IN THE FUTURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0092341

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention