BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2052200 · Received April 12, 2011

    Report

    Report Number
    2024168-2011-02573
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 18, 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
    NY, US
    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. THE ABILITY TO CROSS A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. HOWEVER, IT WAS REPORTED THAT THE LESION WAS CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. THE REPORTED FAILURE TO CROSS, STENT DISLODGEMENT, DIFFICULTY TO REMOVE, FOREIGN BODY IN PATIENT AND ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 LESION WAS IN THE CALCIFIED RIGHT CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED, THE STENT DELIVERY SYSTEM WOULD NOT CROSS THE LESION, AND DURING REMOVAL OF THE DEVICE FROM THE PATIENT THE DEVICE CAUGHT ON THE EDGE OF THE GUIDING CATHETER AND DISLODGED FROM THE BALLOON INTO THE PATIENTS CORONARY. A 1.5 MM BALLOON CATHETER WAS ADVANCED AND SUCCESSFULLY CAPTURED THE STENT AND PULLED IT DOWN TO THE INTRODUCER SHEATH; HOWEVER, THE STENT IMPLANT COULD NOT BE REMOVED THROUGH THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS REPLACED FROM A 6FR TO AN 8FR; HOWEVER, THE STENT IMPLANT COULD STILL NOT BE REMOVED. THE STENT IMPLANT MIGRATED TO BELOW THE PATIENTS KNEE, AND AS THERE WAS GOOD FLOW IN THE VESSELS THE DECISION WAS MADE TO LEAVE THE STENT IN THE LEG. NO PATIENT EFFECTS WERE 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 1010441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention