BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED GRAFT

    MDR report key: 17681456 · Received September 5, 2023

    Report

    Report Number
    9680654-2023-00127
    Event Type
    Injury
    Date Received
    September 5, 2023
    Report Date
    September 5, 2023
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WANG SK, LEMMON GW, GUPTA AK, ET AL. FENESTRATED ENDOVASCULAR ANEURYSM REPAIR-INDUCED ACUTE KIDNEY INJURY DOES NOT RESULT IN CHRONIC RENAL DYSFUNCTION. J VASC SURG. 2019;69(6):1679-1684. DOI:10.1016/J.JVS.2018.09.044 (B)(4) ARE RELATED. THE EVENTS COVERED IN THIS (B)(4) WERE INITIALLY REPORTED UNDER (B)(4). THIS IS A COMBINED INITIAL/FINAL REPORT THAT COVERS THE 25 CASES OF RENAL FAILURE: THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO IMAGING WAS RECEIVED TO ASSIST WITH THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NO INFORMATION WAS RECEIVED. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBERS ARE UNKNOWN. REVIEW OF THE GENERAL INFORMATION FROM THE INSTRUCTIONS FOR USE (IFU) LIKELY SUPPLIED WITH THE DEVICE FOUND THAT IT CONTAINS INFORMATION RELATING TO THE PATIENT SELECTION AND POTENTIAL ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU. FROM THE INFORMATION RECEIVED IT IS DIFFICULT TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENTS. THE REPORTED EVENTS ARE KNOWN EFFECTS OF FAILURE LISTED IN THE IFU. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION MAY BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUPPLIED.

    Description of Event or Problem · 0

    A RETROSPECTIVE REVIEW WAS PERFORMED OF AN INSTITUTIONAL FEVAR DATABASE CAPTURING PREOPERATIVE, INTRAOPERATIVE, AND POSTOPERATIVE VARIABLES RELATED TO THE IMPLANTATION OF CONSECUTIVE ZENITH FENESTRATED ENDOGRAFTS (ZFEN) BETWEEN (B)(6) 2012 AND (B)(6) 2018. AKI IN THIS STUDY WAS BIMODALLY DEFINED AS QUALIFICATION BY EITHER RISK, INJURY, FAILURE, LOSS OF KIDNEY FUNCTION, AND END-STAGE (RIFLE) CRITERIA OR A POSTOPERATIVE SERUM CREATININE (SCR) CONCENTRATION INCREASE OF 0.5 MG/DL FROM BASELINE. GLOMERULAR FILTRATION RATE (GFR) WAS CALCULATED USING THE VALIDATED MODIFICATION OF DIET IN RENAL DISEASE (MDRD) STUDY EQUATION. THE FIRST GROUP OF AKI PATIENTS CONSISTED OF THOSE WHO DEMONSTRATED A >50% POSTPROCEDURAL SERUM CREATININE (SCR) CONCENTRATION INCREASE FROM BASELINE BEFORE HOSPITAL DISCHARGE. THIS DEFINITION WAS OBTAINED FROM THE RISK, INJURY, FAILURE, LOSS OF KIDNEY FUNCTION, AND END-STAGE (RIFLE) SYSTEM PUBLISHED BY THE ACUTE DIALYSIS QUALITY INITIATIVE TO STRATIFY AKI. TO ACCOUNT FOR PATIENTS WITH BASELINE CHRONIC KIDNEY DISEASE, WE ALSO ESTABLISHED AN ABSOLUTE SCR CONCENTRATION INCREASE OF 0.5 MG/DL IN THE POSTOPERATIVE PERIOD AS AN ADDITIONAL DEFINITION OF AKI. THE SCR CONCENTRATION WAS MEASURED IN ALL PATIENTS PREOPERATIVELY AND COMPARED WITH 1-MONTH, 6-MONTH, 1-YEAR, AND 2-YEAR POSTPROCEDURE MEASUREMENTS. TO DETERMINE GLOMERULAR FILTRATION RATE (GFR), ESTIMATES WERE CALCULATED USING THE FOUR-VARIABLE MODIFICATION OF DIET IN RENAL DISEASE (MDRD) STUDY EQUATION: GFR (ML/MIN/1.73 M2) = 175 X SCR^-1.154 X AGE^-0.203 X 1.212 (IF BLACK) X 0.742 (IF FEMALE). THIS IS A HIGHLY VALIDATED ESTIMATE WIDELY ACCEPTED AS THE PREFERRED METHOD OF PREDICTING GFR IN ELDERLY PATIENTS. PATENCY OF RENAL STENTS DURING SURVEILLANCE WAS DETERMINED BY DUPLEX ULTRASOUND OR COMPUTED TOMOGRAPHY ANGIOGRAPHY AT EACH CLINIC VISIT. TECHNICAL SUCCESS WAS DEFINED AS CASE COMPLETION WITHOUT EVIDENCE OF A TYPE I OR TYPE III ENDOLEAK ON COMPLETION ANGIOGRAPHY IN THE SETTING OF SUCCESSFUL DEPLOYMENT OF THE MAIN BODY, CANNULATION OF THE CONTRALATERAL GATE, AND STENTING OF ALL TARGET FENESTRATIONS. POSTOPERATIVE MYOCARDIAL INFARCTION (MI) WAS DEFINED AS ACUTE CHEST PAIN, ELECTROCARDIOGRAPHIC CHANGES, AND PROGRESSIVE ELEVATION OF CARDIAC ENZYMES ON TWO CONSECUTIVE BLOOD DRAWS. POSTOPERATIVE BOWEL ISCHEMIA WAS LIBERALLY DEFINED AS BLOODY DIARRHEA IN THE PRESENCE OF MUCOSAL CHANGES ON ENDOSCOPY. LAST, RESPIRATORY FAILURE WAS DEFINED IN OUR DATABASE AS PROLONGED POSTOPERATIVE INTUBATION (>72 HOURS) OR AN UNPLANNED POSTOPERATIVE REINTUBATION. PRIMARY OUTCOMES OF INTEREST WERE SCR CONCENTRATION AND GFR AT ALL TIME POINTS AFTER THE PROCEDURE BETWEEN THOSE EXHIBITING POSTOPERATIVE AKI AND THOSE WHO DID NOT. THE AKI COHORT CONSISTED OF 14 PATIENTS WHO MET RIFLE CRITERIA AND 10 WHO MET ABSOLUTE INCREASE IN SCR CONCENTRATION CRITERIA. ON UNIVARIATE ANALYSIS, POSTOPERATIVE AKI WAS ASSOCIATED WITH BASELINE RENAL DYSFUNCTION (24.0% VS 45.8%; P = .04) AND CEREBROVASCULAR DISEASE (10.4% VS 29.2%; P = .04). INTERESTINGLY, DIABETES WAS LESS LIKELY TO BE ASSOCIATED WITH AKI (P = .04). WE OBSERVED INCREASED TECHNICAL DIFFICULTY OF THE PROCEDURES RECEIVED BY THE AKI PATIENTS MANIFESTED BY A COMPOSITE OF OPERATIVE (221.2 VS 292.7 MINUTES; P < .01) AND FLUOROSCOPY TIMES (58.1 VS 80.1 MINUTES; P < .01). ALSO PRESENT WAS A TREND TOWARD AN INCREASED NEED FOR IODINATED CONTRAST MATERIAL (93.3 VS 106.1 ML; P = .12) AND NUMBER OF STENTED VISCERAL ARTERIES (2.1 VS 2.3 ARTERIES; P = .18) IN THE AKI COHORT AS WELL. UNFORTUNATELY, THE TYPE OF IODINATED CONTRAST MATERIAL ADMINISTERED ON AN INDIVIDUAL LEVEL WAS NOT RECORDED, BUT ALL PATIENTS DURING THIS TIME PERIOD RECEIVED EITHER IODIXANOL OR IOPAMIDOL. A LOWER RATE OF TECHNICAL SUCCESS WAS ACHIEVED IN THE AKI GROUP COMPARED WITH THE RENALLY UNCOMPLICATED PATIENTS (100% VS 91.7%; P = .04). BOTH CASES IN WHICH TECHNICAL SUCCESS COULD NOT BE ACHIEVED WERE SECONDARY TO AN INABILITY TO ADEQUATELY CANNULATE A SINGULAR RENAL ARTERY OR TO POSITION OUR RENAL ARTERY SHEATH AFTER CANNULATION. FROM A BASELINE RENAL FUNCTION STANDPOINT, OUR TWO COHORTS WERE NOT EQUAL. PATIENTS WITH FEVAR-INDUCED AKI PRESENTED WITH MORE SEVERE CHRONIC RENAL DYSFUNCTION AT BASELINE (SCR CONCENTRATION, 1.1 VS 1.4 MG/DL; P = .02). AS EXPECTED, MAXIMUM (1.1 6 0.4 MG/DL) AND DISCHARGE (1.0 6 0.3 MG/DL) SCR CONCENTRATIONS WERE NOT DIFFERENT IN THE COHORT OF PATIENTS WHO DID NOT EXPERIENCE A DECLINE IN POSTOPERATIVE RENAL INDICES. PATIENTS WITH AKI DEMONSTRATED A MAXIMUM IN-HOSPITAL SCR CONCENTRATION OF 2.76 1.7MG/DL (P < .01) AND A DISCHARGE SCR CONCENTRATION OF 1.9 6 1.3 MG/DL (P = .2). MEAN FOLLOW-UP WAS 1.8 AND 1.3 YEARS IN THE NON-AKI AND AKI COHORTS, RESPECTIVELY. WE DID NOT OBSERVE A DIFFERENCE IN PROCEDURE RELATED OUTCOMES (RUPTURE, MAIN BODY MIGRATION, LIMB IN OUR PATIENTS WITH POSTPROCEDURE AKI, WE OBSERVED A PERSISTENT 57.1% INCREASE IN SCR CONCENTRATION FROM BASELINE AT 1-MONTH (P = .01) FOLLOW-UP. THIS TRANSIENT ELEVATION QUICKLY RESOLVED, NORMALIZING BY THE 6-MONTH OFFICE VISIT AND MAINTAINED AT BASELINE LEVELS WHEN CHECKED AT 1 YEAR AND 2 YEARS AFTER FEVAR. NOT SURPRISINGLY, GFR FOLLOWED A SIMILAR PATTERN, REACHING 65.8% OF BASELINE FILTRATION AT 1 MONTH (P = .02) AND 78.9% AT 6 MONTHS (P = .60) AFTER THE PROCEDURE. GFR CONTINUED TO SLOWLY RECOVER AT THE 1- AND 2-YEAR VISITS, MAINTAINING STATISTICAL INSIGNIFICANCE FROM PREOPERATIVE VALUES. IN THE COHORT OF PATIENTS WHO DID NOT EXPERIENCE POSTPROCEDURE AKI, SCR CONCENTRATION AND GFR WERE MAINTAINED WITHIN A VARIATION OF 10% OF BASELINE TESTS FOR THE ENTIRETY OF FOLLOW-UP. FOR THIS (B)(4): THIS PR COVERS 25 CASES OF RENAL FAILURE. - DURING THE STUDY PERIOD, 120 FEVARS WERE PERFORMED AT OUR INSTITUTION. TWENTY-FOUR (20%) PATIENTS EXHIBITED POSTOPERATIVE ACUTE KIDNEY INJURY BY OUR ESTABLISHED DEFINITIONS (N = 24). - FOUR PATIENTS IN AKI GROUP REQUIRED PERIOPERATIVE (<30-DAY) RENAL REPLACEMENT THERAPY, THREE OF WHOM WERE SUCCESSFULLY WEANED BEFORE DISCHARGE. FEVARS UNCOMPLICATED BY AKI EXHIBITED NO DIFFERENCES IN SCR CONCENTRATION FROM BASELINE TO 1-MONTH, 6-MONTH, 1-YEAR, AND 2-YEAR FOLLOW-UP (MEAN, 1.8 6 1.4 YEARS). IN CONTRAST, PATIENTS EXHIBITING AKI EXPERIENCED AN SCR CONCENTRATION INCREASE OF 57.1% (P ¼ .01) AT 1 MONTH AFTER THE PROCEDURE. THIS ELEVATION DECREASED TO 14.3% (P ¼ .35) AT 6MONTHS AFTER THE PROCEDURE AND WAS MAINTAINED AT BASELINE VALUES AT 1- AND 2-YEAR OFFICE VISITS (FOLLOW-UP, 1.3 6 1.5 YEARS). A SIMILAR PATTERN OF GRADUAL RECOVERY DURING FOLLOW-UP WAS ALSO OBSERVED WITH RESPECT TO CALCULATED GFR. IN PATIENTS INITIATED ON RRT, CONTINUOUS VENOVENOUS HEMOFILTRATION WAS THE MODALITY OF CHOICE. [3 CASES OF <30 DAY AKI/RRF REPORTED UNDER (B)(4)]. THEREFORE, THE FINAL COUNT IS 1 PATIENT. PATIENT OUTCOME: LONG-TERM OUTCOMES. MEAN FOLLOW-UP WAS 1.8 AND 1.3 YEARS IN THE NON-AKI AND AKI COHORTS, RESPECTIVELY. REINTERVENTION (EARLY). 3 PATIENTS (NON-AKI) AND 3 PATIENTS (AKI) (N = 6). REINTERVENTION (LATE). 23 PATIENTS (NON-AKI) AND 2 PATIENTS (AKI) (N = 25). PLEASE NOTE THAT THERE IS REASONABLE EVIDENCE TO SUGGEST THAT THE FOLLOWING EVENTS MENTIONED IN THIS ARTICLE (2: WANG SK, LEMMON GW, GUPTA AK, ET AL. FENESTRATED ENDOVASCULAR ANEURYSM REPAIR-INDUCED ACUTE KIDNEY INJURY DOES NOT RESULT IN CHRONIC RENAL DYSFUNCTION. J VASC SURG. 2019;69(6):1679-1684. DOI:10.1016/J.JVS.2018.09.044) HAVE BEEN REPORTED IN THE ARTICLE (1: WANG SK, GUTWEIN AR, GUPTA AK, ET AL. INSTITUTIONAL EXPERIENCE WITH THE ZENITH FENESTRATED AORTIC STENT GRAFT. J VASC SURG. 2018;68(2):331-336. DOI:10.1016/J.JVS.2017.11.063) RELATED TO (B)(4): THE AUTHORS ARE THE SAME. THE INSTITUTE IS THE SAME. THE AUTHORS' HAVE USED THE SAME INCLUSION CRITERIA. THE TIME FRAME IS ALMOST IDENTICAL. ARTICLE 1 SPANS FROM OCTOBER 2012 TO MARCH 2017. ARTICLE 2 SPANS FROM OCTOBER 2012 TO APRIL 2018. THE DESCRIPTION OF EVENTS ARE CLOSE TO IDENTICAL. THE EVENTS THAT HAVE NOT BEEN REGISTERED FOR THIS ARTICLE ARE AS FOLLOW: 1) TWO IN-HOSPITAL DEATHS OCCURRED IN THE AKI COHORT COMPARED WITH NONE IN THE REMAINING FEVARS (P = .04). ONE PATIENT DEMONSTRATED FRANK COLONIC ISCHEMIA AND REQUIRED REINTERVENTION ON POSTOPERATIVE DAY 1; SHE WOULD GO ON TO HAVE A NONSURVIVABLE MASSIVE INTRACRANIAL HEMORRHAGE WHEN ANTICOAGULATION WAS RESTARTED FOR CHRONIC ATRIAL FIBRILLATION ON POSTOPERATIVE DAY 11. THE REMAINING DEATH RESULTED FROM MULTIORGAN FAILURE SECONDARY TO CARDIOGENIC SHOCK (POSTOPERATIVE MI). THESE HAVE ALREADY BEEN CAPTURED UNDER (B)(4). 2) LATE (>30 DAYS) MORTALITY IS REPORTED AS A TOTAL OF 5 PATIENTS (4 PATIENTS IN NO AKI GROUP AND 1 PATIENT IN AKI GROUP). FOUR LATE DEATHS ARE ALREADY REPORTED UNDER (B)(4)AND 402532. AS THERE IS NO INDICATION IN THE ARTICLE AS TO THE CAUSE OF THE FIFTH DEATH, THIS HAS NOT BEEN RAISED AS A COMPLAINT DUE TO THE LACK OF CAUSALITY. 3) ADVERSE PHYSIOLOGICAL REACTIONS REPORTED UNDER (B)(4): VISCERAL STENT THROMBOSIS IN AKI GROUP (N = 2). SPINAL CORD ISCHEMIA IN AKI GROUP (N = 1). STROKE IN NO AKI GROUP (N = 1). LIMB OCCLUSION (EARLY) IN NO AKI GROUP (N = 1). LIMB OCCLUSION (LATE) IN NO AKI GROUP (N = 2). WOUND COMPLICATION IN NO AKI GROUP (N = 3). DURING FOLLOW-UP, FIVE RENAL STENTS THROMBOSED IN THE NON-AKI COHORT COMPARED WITH ONE RENAL STENT THROMBOSIS IN THE AKI COHORT FOR AN OVERALL PATENCY RATE EXCEEDING 97% (N = 6). NEW HEMODIALYSIS. 2 PATIENTS IN NO AKI GROUP AND 1 PATIENT IN AKI GROUP (N = 3). 4) ADVERSE PHYSIOLOGICAL REACTIONS REPORTED UNDER (B)(4): BOWEL ISCHEMIA IN AKI GROUP (N = 5) ((B)(4)). ALL CASES OF BOWEL ISCHEMIA WERE UNRELATED TO TARGET VESSEL THROMBOSIS. FOUR OF FIVE PATIENTS EXHIBITED POSTOPERATIVE BLOODTINGED DIARRHEA AND EVIDENCE OF MUCOSAL ISCHEMIA ON SIGMOIDOSCOPY BUT RECOVERED WITHOUT INTERVENTION. MYOCARDIAL INFARCTION IN NON AKI GROUP (N = 1). MYOCARDIAL INFARCTION IN AKI GROUP (N = 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974852 ZENITH FENESTRATED GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other