BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132611 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04295
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    December 4, 2009
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING A STENT DUE TO STENT RECOIL CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, LESION CHARACTERISTICS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, AND/OR LESION SIZE. TO HELP ENSURE THAT THE REPORTED DIFFICULTIES ARE NOT A RESULT OF A MANUFACTURING DEFICIENCY, STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. ADDITIONALLY, A SAMPLING OF UNITS FROM EVERY LOT IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DEPLOYMENT DIMENSIONS, AS WELL AS STENT UNIFORMITY OF EXPANSION. IN THIS CASE, THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE ASSISTED THE INVESTIGATION. THERE WAS NO NOTE OF ANY DAMAGE TO THE SDS OR STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. ANGINA, ISCHEMIA, AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE PATIENT UNDERWENT A XIENCE V STENTING PROCEDURE IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD) WITH ONE 3.0 X 28 XIENCE V STENT. ON (B)(6) 2009, THE PATIENT UNDERWENT FUNCTIONAL STRESS TEST, FOR RECURRENT ANGINAL SYMPTOMS, WHICH WAS POSITIVE; DEMONSTRATING MYOCARDIAL ISCHEMIA. ON (B)(6) 2009 THE CORONARY ANGIOGRAPHY SHOWED LAD 20-30% IN-STENT RESTENOSIS AND STENT RECOIL. IMMEDIATELY AFTER THE AREA OF STENTING, THERE IS DIFFUSE 20% DISEASE, 30% DISEASE IN THE MID PORTION OF THE CIRCUMFLEX AND FOCAL 80% LESION PRIOR TO BIFURCATION. THEREFORE, THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY REVASCULARIZATION WITH TWO XIENCE V STENTS, ONE 2.5 X 12 IN THE DISTAL CIRCUMFLEX AND ONE 2.75 X 8 IN THE PLAD. THE PATIENT'S CONDITION RESOLVED AND WAS DISCHARGED ONE DAY AFTER THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 8102761

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R