BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2031898 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02065
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    November 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). 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 THE STENT (MATERIAL STRESS/ FATIGUE) OR INTERACTION WITH THE ACCESSORY DEVICES, LESION AND/OR ANATOMY. FATIGUE FROM CARDIAC DYNAMICS AND MOTION MAY ALSO CONTRIBUTE TO STENT FRACTURES DURING OR AFTER THE PROCEDURE. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF THE 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, AS LISTED IN THE INSTRUCTIONS FOR USE (IFU) ARE 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 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. IN THIS CASE, 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). 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). 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 CAN 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

    SUBSEQUENT TO THE SUPPLEMENTAL MEDWATCH REPORT, RECEIVED CASE REPORT ARTICLE REPORTING THAT IN (B)(6) 2009, THE PATIENT DEVELOPED RECURRENT ANGINA AND WAS FOUND TO HAVE IN-STENT RESTENOSIS OF AN UNSPECIFIED BARE METAL STENT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO XIENCE V STENTS (2.5X18 AND 2.5X25) AND A 2.25X 15 PROMUS STENT WERE IMPLANTED FROM THE DISTAL TO PROXIMAL WITH GOOD ANGIOGRAPHIC RESULTS. FIVE MONTHS POST IMPLANT, THE PATIENT PRESENTED WITH PROGRESSIVE ANGINA. REPEAT ANGIOGRAPHY DEMONSTRATED IN-STENT RESTENOSIS IN THE 2.5X18 XIENCE V STENT AND THE 2.25X15 PROMUS. FURTHER ANGIOGRAPHIC EVALUATION REVEALED STENT STRUT SEPARATION IN THE TWO STENTS AT THE FOCAL RESTENOSIS SITE INDICATING A COMPLETE STENT FRACTURE. PRE-DILATATION OF BOTH SITES WAS PERFORMED AND TWO NON-ABBOTT STENT WERE DEPLOYED COVERING THE STENT FRACTURES. POST DILATATION WAS PERFORMED WITH EXCELLENT RESULTS. IN (B)(6) 2009, THE PATIENT PRESENTED AGAIN WITH TROPONIN-NEGATIVE PROGRESSIVE ANGINA. ANGIOGRAPHY REVEALED FRACTURE OF THE NON-ABBOTT STENT AND RESTENOSIS WITHIN THE LAD. PERCUTANEOUS INTERVENTION WAS PERFORMED WITH DEPLOYMENT OF A NON-ABBOTT STENT WITH GOOD RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT FRACTURED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT 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 67 YR Hospitalization| R STENTS: XIENCE V AND PROMUS