BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031897 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02064
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    September 1, 2009
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). FACTORS THAT MAY CONTRIBUTE TO STENT FRACTURES/ BREAK INCLUDE, BUT ARE NOT LIMITED TO, PROCESSING AND/OR HANDLING IN MANUFACTURING, HANDLING DURING PREPARATION FOR USE, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, PRODUCT SIZE SELECTION, SEVERE TORQUING OR KINKING OF STENT (MATERIAL STRESS/ FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. FATIGUE FROM CARDIAC DYNAMICS AND MOTION MAY CONTRIBUTE TO STENT FRACTURES DURING OR AFTER THE PROCEDURE. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. INFORMATION WAS RECEIVED STATING THAT FLUOROSCOPIC IMAGES REVEALED A GAP IN THE MIDDLE OF THE STENT INDICATING A COMPLETE STENT FRACTURE PROBABLY RELATED TO THE SEVERE CALCIFICATION AND ANGULATIONS OF THE ARTERY. IT IS POSSIBLE THAT THE LESION CHARACTERISTICS OR OVER INFLATION COULD HAVE CONTRIBUTED TO THE REPORTED STENT FRACTURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. ANGINA AND STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED STENT FRACTURE POSSIBLY CONTRIBUTED TO THE REPORTED RESTENOSIS, WHICH SUBSEQUENTLY LED TO THE SECONDARY EFFECTS OF ANGINA, EKG/ ECG CHANGES, ELEVATED CARDIAC ENZYMES AND REQUIRED ADDITIONAL TREATMENT AND HOSPITALIZATION. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED PATIENT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE, IF ANY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE STENT FRACTURE/ BREAK AND THE RELATIONSHIP TO THE REPORTED PATIENT EFFECTS COULD NOT BE DETERMINED, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). STENT FRACTURE CAN BE THE RESULT OF SEVERE TORQUING OR KINKING OF THE STENT IMPLANT SUCH THAT THERE WOULD BE MATERIAL STRESS/FATIGUE THAT WOULD WEAKEN THE MATERIAL AND RESULT IN A BREAKAGE OF THE STENT IMPLANT. TO HELP ENSURE THIS DAMAGE IS NOT THE RESULT OF THE MANUFACTURING PROCESS, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR DAMAGE AT NUMEROUS POINTS IN THE MANUFACTURING PROCESS. IT IS POSSIBLE THAT OVER INFLATION OR ANATOMICAL CONDITIONS COULD HAVE CONTRIBUTED TO THE REPORTED STENT FRACTURE. IN THIS CASE, THE REPORTED STENT FRACTURE COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT FRACTURED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE SUPPLEMENTAL MEDWATCH REPORT, AN ARTICLE ENTITLED: STENT FRACTURE AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION, WAS RECEIVED REPORTING THE FOLLOWING: IN (B)(6) 2009, THE PATIENT EXPERIENCED EXERTIONAL CHEST PAIN AND UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED 90% MID AND 80% DISTAL RIGHT CORONARY ARTERY (RCA) STENOSIS. THE DISTAL LESION WAS TREATED WITH ROTATIONAL ATHERECTOMY FOLLOWED BY DEPLOYMENT OF A 2.25X23 XIENCE V STENT AT 16 ATMOSPHERES (ATMS). A 2.75X28 XIENCE V STENT WAS DEPLOYED AT 16 ATMS IN THE MID-SEGMENT AND POST-DILATED. EXCELLENT RESULTS WERE ACHIEVED AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. FOUR MONTHS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PROLONGED EPISODE OF CHEST PAIN ASSOCIATED WITH T WAVE INVERSION IN THE INFERIOR LEADS AND AN ELEVATED TROPONIN. ANGIOGRAPHY REVEALED IN-STENT RESTENOSIS IN THE MID RCA. FLUOROSCOPIC IMAGES REVEALED A GAP IN THE MIDDLE OF THE STENT INDICATING A COMPLETE STENT FRACTURE PROBABLY RELATED TO THE SEVERE CALCIFICATION AND ANGULATION OF THE ARTERY. PRE-DILATATION WAS PERFORMED AND A NON-ABBOTT STENT WAS DEPLOYED WITH EXCELLENT FINAL RESULTS. THE PATIENT REMAINED FREE OF SYMPTOMS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R