BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 4225846 · Received November 5, 2014

    Report

    Report Number
    9612164-2014-01417
    Event Type
    Death
    Date Received
    November 5, 2014
    Date of Event
    May 28, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS: ROOT CAUSE UNDETERMINED, INHERENT RISK OF PROCEDURE-DEATH. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. NO DEVICE RETURNED. CONCLUSION: INHERENT RISK OF PROCEDURE - DEATH. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. ROOT CAUSE UNDETERMINED. (B)(4) - DATE OF PUBLICATION JOURNAL OF VASCULAR SURGERY VOLUME 60, ISSUE 4, OCTOBER 2014¿¿ PATIENTS CARRYING CYP2C19 LOSS OF FUNCTION ALLELES HAVE A REDUCED RESPONSE TO CLOPIDOGREL THERAPY AND A GREATER RISK OF IN-STENT RESTENOSIS AFTER ENDOVASCULAR TREATMENT OF LOWER EXTREMITY PERIPHERAL ARTERIAL DISEASE¿. AVAILABLE ON LINE AT: HTTP://DX.DOI.ORG/10.1016/J.JVS.2014.03.293.

    Description of Event or Problem · 1

    THIS STUDY EVALUATED THE RELATIONSHIP BETWEEN THE CYTOCHROME P450 (CYP) 2C19 GENOTYPE AND THE ANTIPLATELET EFFECT OF CLOPIDOGREL THERAPY AND INVESTIGATED WHETHER GENOTYPING CAN PREDICT THE RISK OF ISCHEMIC EVENTS AFTER ENDOVASCULAR TREATMENT (ET) OF LOWER EXTREMITY PERIPHERAL ARTERIAL DISEASE. FROM JANUARY 2011 TO JULY 2012, 120 CONSECUTIVE PATIENTS WITH ARTERIOSCLEROSIS OBLITERANS IN THE SUPERFICIAL FEMORAL ARTERY WERE INCLUDED IN A PROSPECTIVELY MAINTAINED DATABASE. PATIENTS RECEIVED 75 MG CLOPIDOGREL AND 100 MG ASPIRIN DAILY FOR AT LEAST 5 DAYS BEFORE TAQMAN OF CYP2C19 SINGLE-NUCLEOTIDE POLYMORPHISMS AND THROMBOELASTOGRAPHY OF THE CLOPIDOGREL RESPONSE. ET WAS SUBSEQUENTLY PERFORMED, ONE OR MORE NITINOL STENTS WERE PLACED INCLUDING MEDTRONIC COMPLETE SE. THE STENT LENGTHS RANGED FROM 5 TO 7 CM; AND THE MEAN NUMBER OF STENTS PLACED WAS 1.54 6 0.59 IN THE THOSE WITHOUT LOF ALLELES AND 1.69 6 0.68 IN THOSE WITH LOF ALLELES (P ¼ .604); THE MEAN LENGTH OF TREATED ARTERIAL SEGMENTS WAS 123.5 6 84 MM IN PATIENTS WITHOUT LOF ALLELES AND 12.84 6 7.6 CM IN PATIENTS WITH LOF ALLELES (P ¼ .725). FOLLOW-UP EVALUATIONS, INCLUDING DUPLEX ULTRASOUND IMAGING AND ANKLE-BRACHIAL INDEX ASSESSMENT, WERE PERFORMED AT 1, 3, 6, AND 12 MONTHS AFTER ET. DURING THE FOLLOW-UP, STENT PATENCY WAS ASSESSED BY ULTRASOUND IMAGING, COMPUTED TOMOGRAPHY ANGIOGRAPHY, OR DIGITAL SUBTRACTION ANGIOGRAPHY. A TOTAL OF 74 ET PROCEDURES WERE PERFORMED. FIFTY OF THE ENROLLED PATIENTS (41.7%) COMPLETED THE FOLLOW-UP EXAMINATIONS AND WERE INCLUDED IN THE ANALYSIS. THE MEAN DURATION OF FOLLOW-UP WAS 9.8 ± 2.1 MONTHS (RANGE, 1-30 MONTHS). CARRIERS OF AT LEAST ONE CYP2C19 LOSS-OF-FUNCTION (LOF) ALLELE HAD A DIMINISHED PHARMACODYNAMIC RESPONSE TO CLOPIDOGREL (51.6 ± 20.1 VS 39.8 ± 15.2 FOR PATIENTS WITHOUT AND WITH LOF ALLELES, RESPECTIVELY; P = .022). CARRIERS OF ONE LOF ALLELE HAD AN INCREASED INCIDENCE OF ISCHEMIC EVENTS COMPARED WITH PATIENTS WITHOUT ANY LOF ALLELES (59.0% VS 20.8%, RESPECTIVELY; P = .008). THIS TREND WAS EVEN MORE EVIDENT IN PATIENTS WITH TWO LOF ALLELES COMPARED WITH PATIENTS WITH NO LOF ALLELES (100% VS 20.8% ISCHEMIC EVENTS; P = .002). THE CUMULATIVE PRIMARY PATENCY RATE AT 12 MONTHS WAS 56.0%, WITH SIGNIFICANT DIFFERENCES BETWEEN GROUPS (73.1% VS 34.6% IN PATIENTS WITHOUT AND WITH LOF ALLELES, RESPECTIVELY; P = .0.006). CYP2C19 LOF CARRIER STATUS WAS ASSOCIATED WITH AN INCREASED RATE OF PRIMARY END POINTS (P = .007). ON THE BASIS OF THEIR ADENOSINE DIPHOSPHATE-INDUCED PLATELET AGGREGATION, PATIENTS WITH HIGH PLATELET REACTIVITY HAD A SIGNIFICANTLY HIGHER RISK OF ISCHEMIC EVENTS (P = .012). CYP2C19 GENOTYPIC CLASSIFICATION (ADJUSTED HAZARD RATIO, 2.688; 95% CONFIDENCE INTERVAL, 1.366-5.288; P = .004) AND HISTORY OF SMOKING (ADJUSTED HAZARD RATIO, 2.430; 95% CONFIDENCE INTERVAL, 1.024-5.765; P = .044) WERE INDEPENDENT RISK FACTORS FOR ISCHEMIC EVENTS. ADVERSE EVENTS REPORTED DURING FOLLOW UP INCLUDED DEATH, ISCHEMIC EVENTS, ISR, THROMBOSIS, OCCLUSION, MYOCARDIAL INFRACTION AND PTA CYP2C19 LOF ALLELES WERE ASSOCIATED WITH A DIMINISHED PLATELET RESPONSE TO CLOPIDOGREL TREATMENT. PATIENTS CARRYING CYP2C19 LOF ALLELES WHO ARE TREATED WITH CLOPIDOGREL MAY TREND TOWARD A POOR PROGNOSIS AFTER ET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710876 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR