BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2935997 · Received January 30, 2013

    Report

    Report Number
    2024168-2013-00479
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2003
    Report Date
    January 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PROCEDURAL SUCCESS WAS DEFINED AS THE ACHIEVEMENT OF RESIDUAL IN-STENT STENOSIS OF LESS THAN 30%, ASSOCIATED WITH THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 2-3 FLOW WITHOUT THE OCCURRENCE OF DEATH, MI, OR REPEAT TARGET LESION REVASCULARIZATION DURING THE INDEX HOSPITALIZATION. POST PROCEDURAL MI WAS DEFINED AS CREATINE KINASE MB FRACTION (CK-MB) INCREASE GREATER THAN 3 TIMES THE UPPER LIMIT OF NORMAL IF BASELINE CK-MB WAS WITHIN NORMAL LIMITS AND 50% INCREASE OVER BASELINE IF BASELINE CK-MB WAS ELEVATED. RESULTS: CORONARY ANGIOGRAMS AND PROCEDURAL OUTCOMES FOR 109 PATIENTS OF THOSE PATIENTS WHO SPECIFICALLY UNDERWENT 113 OSTIAL SAPHENOUS VEIN GRAFT (SVG) PTCI (STENTING) PROCEDURES BETWEEN THE DATES OF JANUARY 2003 AND MAY 2010, WERE REVIEWED, REVEALING THE FOLLOWING DEVICE ISSUE WITH UNSPECIFIED XIENCE V STENTS (ONE OF WHICH WAS A 3.5X15MM UNSPECIFIED XIENCE V STENT: IN 8 PROCEDURES, A RETRIEVAL CATHETER WAS UNABLE TO BE ADVANCED THROUGH EACH UNSPECIFIED STENT (5 STENTS WERE IDENTIFIED AS UNSPECIFIED XIENCE V STENTS) TO RETRIEVE THE UNSPECIFIED NON-ABBOTT EMBOLIC PROTECTION DEVICE FILTERS; REPORTEDLY SUBSEQUENT ATTEMPTS TO ADVANCE A RETRIEVAL CATHETER THROUGH THE STENT MAY BE HINDERED BY THE CATHETER HITTING THE PROTRUDING STENT SEGMENT, AS STENTING OSTIAL LESIONS INVOLVE DEPLOYMENT OF THE STENT 1MM INTO THE AORTA TO ENSURE ADEQUATE OSTIAL COVERAGE. IN ONE OF THE EIGHT PROCEDURES, THE FILTER WAS REPORTEDLY REQUIRED TO BE REMOVED FORCEFULLY THROUGH THE STENT, WITH THE FILTER REMAINING IN ITS OPEN POSITION. IN ANOTHER CASE, THE RETRIEVAL CATHETER WAS ABLE TO BE ADVANCED THROUGH THE STENT AFTER POST-DILATING THE STENT. IN THE REMAINING PROCEDURES, OTHER UNSPECIFIED RETRIEVAL CATHETERS WERE ABLE TO SUCCESSFULLY CROSS THROUGH THE STENTS. THE MAIN FINDING OF THIS STUDY IS THAT EPDS CAN BE UTILIZED IN THE MAJORITY OF OSTIAL SVG LESIONS, BUT IN 11% OF CASES FILTER RETRIEVAL CAN BE CHALLENGING AND MAY RARELY (IN APPROXIMATELY 1%) LEAD TO A SIGNIFICANT COMPLICATION. NO ADDITIONAL INFORMATION WAS NOTED. AGE ESTIMATED. DATE OF IMPLANT ESTIMATED. CONCOMITANT MEDICAL DEVICE: EMBOLIC PROTECTION: BOSTON SCIENTIFIC FILTERWIRE; SPIDER EV3. (B)(4). IT IS INDICATED THAT THE DEVICES ARE NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORDS AND LOTS COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. IT WAS REPORTED THAT THE DEVICES WERE IMPLANTED TO TREAT OSTIAL SAPHENOUS VEIN GRAFT (SVG) LESIONS. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: XIENCE V IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES: SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT IMPLANT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ARTICLE: ROLE OF EMBOLIC PROTECTION DEVICES IN OSTIAL SAPHENOUS VEIN GRAFT LESIONS. IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2012; 80:1120-1126 PUBLICATION (PUBLISHED BY WILEY PERIODICALS, 2012).

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE FOLLOWING ARTICLE: ROLE OF EMBOLIC PROTECTION DEVICES IN OSTIAL SAPHENOUS VEIN GRAFT LESIONS IN CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2012; 80:1120-1126 PUBLICATION (PUBLISHED BY WILEY PERIODICALS, 2012). BACKGROUND: PERCUTANEOUS CORONARY INTERVENTION (PCI) OF SAPHENOUS VEIN GRAFTS (SVGS) CAN BE COMPLICATED BY DISTAL EMBOLIZATION CAUSING SLOW-FLOW OR NO-REFLOW AND PERIPROCEDURAL MYOCARDIAL INFARCTION (MI). USE OF EMBOLIC PROTECTION DEVICES (EPDS) CAN SIGNIFICANTLY DECREASE THE RISK OF MI. THE GOAL OF THIS STUDY WAS TO EXAMINE THE FREQUENCY AND OUTCOMES OF EPD USE IN OSTIAL SVG LESIONS. ALL PATIENTS WERE MEN WITH HIGH PREVALENCE OF CORONARY ARTERY DISEASE RISK FACTORS AND THEY MOST FREQUENTLY PRESENTED WITH AN ACUTE CORONARY SYNDROME. METHODS: BETWEEN JANUARY 2003 AND MAY 2010, 342 CONSECUTIVE PATIENTS UNDERWENT SVG PCI AT THE INSTITUTION. OF THOSE PATIENTS, 109 (32%) UNDERWENT PCI OF 113 OSTIAL SVG LESIONS AND WERE INCLUDED IN THIS STUDY. OSTIAL LESIONS WERE DEFINED AS LESIONS THAT WERE PRESENT WITHIN 5 MM FROM AORTOCORONARY SVG ANASTOMOSIS. THE CORONARY ANGIOGRAMS AND PROCEDURAL REPORTS OF OSTIAL SVG INTERVENTIONS WERE REVIEWED TO DETERMINE THE FEASIBILITY OF EPD UTILIZATION, THE ACTUAL EPD USE AND THE OCCURRENCE OF ANY PERIPROCEDURAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41184 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 Required Intervention