BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2951006 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00756
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: PROWATER; CHOICE PT EXTRA GUIDE CATH: 6FR EBU 3.5. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED AND THE CINE IMAGES THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, DISSECTION IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES. THE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LOCATED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE FIRST DIAGONAL. A PROWATER GUIDE WIRE WAS ADVANCED INTO THE DIAGONAL AND THE BALANCE MIDDLEWEIGHT (BMW) ELITE WAS ADVANCED INTO THE LAD; HOWEVER, DURING MANIPULATION OF THE GUIDE WIRE INTO THE LAD, RESISTANCE WAS FELT DISTALLY AND THE TORQUABILITY OF THE GUIDE WIRE BECAME WORSE AND DID NOT FEEL RIGHT, AS IF THE GUIDE WIRE WAS WRAPPED. THE DECISION WAS MADE TO REMOVE THE BMW ELITE GUIDE WIRE. AS GUIDE WIRE WAS PULLED OUT INTO THE GUIDING CATHETER, RESISTANCE WAS FELT AND AS THE DISTAL END OF THE GUIDE WIRE WAS EXITING THE GUIDING CATHETER, THE GUIDE WIRE SEPARATED INTO TWO PIECES. THE DISTAL PORTION WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. THE PROCEDURE CONTINUED ON WITH THE SAME PROWATER GUIDE WIRE AND A NON-ABBOTT GUIDE WIRE, AFTER WHICH TWO XIENCE V STENTS, A 3.0 X 18 MM AND A 2.5 X 12 MM. WERE DEPLOYED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. CINE CD REVIEW REVEALED THAT AFTER DEPLOYMENT OF THE 3.0 X 18 MM XIENCE V STENT, A WAIST REMAINED. AFTER POST-DILATATION OF THE STENT, A DISTAL EDGE DISSECTION WAS OBSERVED, WHICH REQUIRED TREATMENT WITH AN ADDITIONAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54859 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention