BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FENESTRATED GRAFT

    MDR report key: 17628993 · Received August 27, 2023

    Report

    Report Number
    9680654-2023-00112
    Event Type
    Death
    Date Received
    August 27, 2023
    Report Date
    August 28, 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

    THIS IS A COMBINED INITIAL/FINAL REPORT TO COVER ONE PATIENT DEATH FROM MULTI SYSTEM ORGAN FAILURE SECONDARY TO RENAL FAILURE. NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS RECEIVED. NO IMAGING WAS RECEIVED TO ASSIST THE INVESTIGATION. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) LIKELY SUPPLIED WITH THE DEVICE (AS THE LOT NUMBER IS UNKNOWN, THE IFU CURRENTLY SUPPLIED WITH ZFEN DEVICES WAS REVIEWED) FOUND TO CONTAIN APPROPRIATE WARNINGS, PRECAUTIONS, AND INSTRUCTIONS TO THE USER, INCLUDING: 5. ADVERSE EVENTS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ORGAN IMPAIRMENT / LOSS DUE TO SIDE-BRANCH VESSEL OCCLUSION (IN PARTICULAR, RENAL AND / OR GASTROINTESTINAL IMPAIRMENT / LOSS) RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E G , ARTERY STENOSIS OR OCCLUSION, CONTRAST TOXICITY, INFARCT, INSUFFICIENCY, FAILURE) 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP THE USE OF THIS DEVICE REQUIRES ADMINISTRATION OF RADIOGRAPHIC AGENTS. PATIENTS WITH PRE-EXISTING RENAL INSUFFICIENCY MAY HAVE AN INCREASED RISK OF POST-OPERATIVE RENAL FAILURE 4.3 IMPLANT PROCEDURE RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS IT IS RECOMMENDED THAT ALL VESSELS ACCOMMODATED BY A SMALL FENESTRATION BE STENTED IN ORDER TO SECURE POSITIVE ALIGNMENT OF THE GRAFT FENESTRATION WITH THE VESSEL ORIGIN 4. WARNINGS AND PRECAUTIONS 4.1 GENERAL USE INFORMATION THE LONG-TERM PERFORMANCE OF FENESTRATED ENDOVASCULAR GRAFTS, INCLUDING THE STENTS PLACED IN FENESTRATIONS/SCALLOPS, HAS NOT YET BEEN ESTABLISHED ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E G , ENDOLEAKS, ENLARGING ANEURYSMS, CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT, OR STENOSIS / OCCLUSION OF VESSELS ACCOMMODATED BY FENESTRATIONS) SHOULD RECEIVE ENHANCED FOLLOW-UP. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION RECEIVED A DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THIS IS A KNOWN EFFECT OF FAILURE, AND IT IS LISTED IN THE RISK DOCUMENT AND 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. EVENT INFORMATION TAKEN FROM REVIEW OF A LITERATURE ARTICLE: WANG, S, K. ET AL 2017: ¿INSTITUTIONAL EXPERIENCE WITH THE ZENITH FENESTRATED AORTIC STENT GRAFT¿. DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2017.11.063.

    Description of Event or Problem · 0

    WANG, S.K., ET AL., INSTITUTIONAL EXPERIENCE WITH THE ZENITH FENESTRATED AORTIC STENT GRAFT. J VASC SURG, 2018. 68(2): P. 331-336. TOTAL PATIENT NUMBER: 100 SHORT-NECK INFRARENAL AAA AND JAAA. MEN: 86% (86/100). AGE: 72.6±7.8 YEARS. PROCEDURES WERE PERFORMED FROM OCTOBER 2012 TO MARCH 2017. ALL PATIENTS WERE TREATED WITH ZFEN. FOLLOW-UP: 1.7±1.4 YEARS. ALL BUT ONE OF THE PROCEDURES WERE ELECTIVE IN NATURE. OVERALL INTRAOPERATIVE CHARACTERISTICS INCLUDED A MEAN BLOOD LOSS (ESTIMATED BLOOD LOSS) OF 388 6 385 ML, FLUOROSCOPY TIME OF 63 6 30 MINUTES, RADIATION DOSE OF 437 6 272 RAD, CONTRAST MATERIAL VOLUME OF 99 6 36 ML, AND OPERATIVE TIME OF 236 6 87 MINUTES. AVERAGE NUMBER OF VISCERAL ARTERIES STENTED WAS 2.1 6 0.5. TECHNICAL SUCCESS WAS ACHIEVED IN 98% OF THE PATIENTS. STATISTICALLY SIGNIFICANT (P < .05) IMPROVEMENT IN ESTIMATED BLOOD LOSS (2.1-FOLD) WAS OBSERVED IN THE SECOND HALF OF OUR SERIES. INTERESTINGLY, NO IMPROVEMENTS WERE MADE IN TERMS OF FLUOROSCOPY TIME, RADIATION EXPOSURE, CONTRAST MATERIAL USE, OR OPERATIVE TIME. HOWEVER, PROCEDURAL DIFFICULTY INCREASED IN THE LAST HALF BY NUMBER OF VISCERAL ARTERIES STENTED AS A SURROGATE (1.9 VS 2.2; P < .05). MEAN LENGTH OF STAY WAS 3.6 6 4.3 DAYS. PERIOPERATIVE MORTALITY AT 30 DAYS WAS 2%. PERIOPERATIVE MORBIDITY INCLUDED A 5% INCIDENCE OF ANY BOWEL ISCHEMIA, 1% OF SPINAL CORD ISCHEMIA, 3% OF RENAL FAILURE REQUIRING HEMODIALYSIS, 1% OF STROKE, AND 4% OF MYOCARDIAL INFARCTION. AVERAGE FOLLOW-UP WAS 1.7 6 1.4 YEARS. REINTERVENTION DURING THE FOLLOW-UP PHASE WAS 20%. OF THE 209 VISCERAL ARTERIES STENTED, WE NOTED 6 INSTANCES OF STENT THROMBOSIS, 6 OF KINKING OR STENOSIS, AND 1 OF STENT FRACTURE IN FOLLOW-UP. ENDOLEAK, MOST COMMONLY TYPE II, WAS PRESENT OR COULD NOT BE EXCLUDED IN 15% OF ALL FEVARS AT LAST AVAILABLE COMPUTED TOMOGRAPHY ANGIOGRAPHY. ALL CASES WERE CONDUCTED BY ONE OR A COMBINATION OF THREE TOTAL ATTENDING VASCULAR SURGEONS. AFTER THE FIRST THIRD OF OUR EXPERIENCE, WHEN TWO FACULTY MEMBERS PERFORMED THE PROCEDURE JOINTLY, ZFENS WERE IMPLANTED BY A SINGLE ATTENDING SURGEON WITH ASSISTANCE FROM A FELLOW. DURING THE OPERATION, ALL PATIENTS WERE MAINTAINED UNDER GENERAL ANESTHESIA. AS OUR EXPERIENCE MATURED, WE TRANSITIONED TO PERFORMING OUR ACCESSES BY A PERCUTANEOUS TECHNIQUE WITH THE ASSISTANCE OF A PERCLOSE DEVICE (ABBOTT VASCULAR, SANTA CLARA, CALIF). GROIN CUTDOWN WAS MADE IF THERE WAS A SIGNIFICANTLY CALCIFIED ANTERIOR COMMON FEMORAL ARTERY OR IF IT WAS A REOPERATIVE GROIN DISSECTION. IF BRACHIAL ACCESS WAS REQUIRED DURING THE CASE, OPEN EXPOSURE OF THE ARM WAS PERFORMED. ALL PROCEDURES OCCURRED IN A HYBRID OPERATING ROOM WITH A FLOOR-MOUNTED MOBILE C-ARM (ARTIS ZEEGO; SIEMENS MEDICAL SOLUTIONS USA, MALVERN, PA). AFTER BILATERAL FEMORAL ARTERY ACCESS WAS OBTAINED, PATIENTS WERE ANTICOAGULATED WITH 100 UNITS/KG OF HEPARIN ADMINISTERED INTRAVENOUSLY. ACTIVATED CLOTTING TIMES WERE MAINTAINED IN EXCESS OF 250 SECONDS FOR THE DURATION OF THE CASE. THE CUSTOM PROXIMAL MAIN BODY WAS POSITIONED AND PARTIALLY DEPLOYED OVER A STIFF WIRE. FENESTRATIONS OF THE TARGET VESSELS WERE CANNULATED, AND ICAST (ATRIUM MEDICAL, HUDSON, NH) COVERED STENTS WERE DEPLOYED WITH APPROXIMATELY 6 MM OF THE BALLOON EXPANDABLE STENT IN THE AORTA AND THE REMAINDER IN THE TARGET VESSEL. THE COVERED STENTS WERE THEN FLARED WITH A MYNX FLASH OSTIAL BALLOON (CORDIS, FREMONT, CALIF) TO CREATE A SEAL BETWEEN THE VISCERAL STENT AND MAIN BODY FENESTRATION. IF THE DISTAL PORTION OF THE VISCERAL STENT LANDED IN TORTUOUS ANATOMY, WE EXTENDED THE DISTAL LANDING ZONE WITH A BARE-METAL STENT TO A MORE SUITABLE LOCATION. SUPERIOR MESENTERIC ARTERY (SMA) AND CELIAC ARTERY SCALLOPS OR LARGE NONREINFORCED FENESTRATIONS WERE NOT ROUTINELY STENTED. THE DISTAL MAIN BODY WAS SUBSEQUENTLY DEPLOYED, AND THE REMAINING PORTIONS OF THE PROCEDURE PROCEEDED IN THE SAME MANNER AS THAT OF ENDOVASCULAR ANEURYSM REPAIR. AT CASE CONCLUSION, ALL PATIENTS WERE TRANSFERRED TO A DEDICATED CARDIOVASCULAR INTENSIVE CARE UNIT WITH STRICT SUPINE PRECAUTIONS FOR THE FIRST 6 HOURS. PATIENTS WERE IMMEDIATELY INITIATED ON ASPIRIN (81 MG DAILY) AND CLOPIDOGREL (75 MG DAILY) FOR THE FIRST 3 MONTHS, AT WHICH POINT CLOPIDOGREL WAS DISCONTINUED. DISCHARGE WAS CONSIDERED STARTING THE FIRST POSTOPERATIVE DAY IF THE PATIENTS WERE AMBULATING, EATING, AND MAKING URINE WITHOUT SIGNS OF RENAL INJURY. AFTER DISCHARGE FROM THE HOSPITAL, PATIENTS WERE SEEN IN THE CLINIC AT 1 MONTH, 6 MONTHS, AND 12 MONTHS POSTOPERATIVELY FOLLOWED BY ANNUAL VISITS. AT EVERY CLINIC VISIT, A CT ANGIOGRAM AND A SERUM CREATININE CONCENTRATION WERE OBTAINED IF FEASIBLE. IF RENAL STENOSIS WAS SUGGESTED ON CTA, A CONFIRMATORY RENAL DUPLEX ULTRASOUND SCAN WAS OBTAINED. IF THE PATIENT HAD RENAL DYSFUNCTION PRECLUDING REGIMENTED CTA, LOWER EXTREMITY ARTERIAL DOPPLER ULTRASOUND, NON-CONTRASTED CT OF THE ABDOMEN AND PELVIS, AND DUPLEX ULTRASOUND EXAMINATION OF THE AORTA AND VISCERAL ARTERIES WERE SUBSTITUTED. IN 12 PATIENTS, FEVAR WAS PERFORMED AS A REOPERATION AFTER PREVIOUS OPEN OR ENDOVASCULAR REPAIR. THESE PROCEDURES INCLUDED SIX OPEN AND SIX ENDOVASCULAR AORTIC RECONSTRUCTIONS. TWENTY-ONE PERCENT OF OUR POPULATION HAD A HOSTILE ABDOMEN FROM PREVIOUS LAPAROTOMIES, WHEREAS 14% OF THE COHORT HAD A PREVIOUS NONCORONARY ENDOVASCULAR INTERVENTION. ALL PROCEDURES, EXCEPT FOR ONE, WERE PERFORMED ELECTIVELY. THIS EXCEPTION WAS A PATIENT SCHEDULED FOR FEVAR WHO PRESENTED TO THE EMERGENCY DEPARTMENT WITH ACUTE ABDOMINAL AND BACK PAIN ALONG WITH CTA CONCERNING FOR IMPENDING RUPTURE WHILE WAITING FOR HER OPERATIVE DATE. THE DEVICE WAS ALREADY AVAILABLE, AND AN EMERGENT PROCEDURE WAS PERFORMED. PATIENTS WERE EXCLUDED FROM ZFEN IF THERE WAS PRESENCE OF SEVERE AORTOILIAC OCCLUSIVE DISEASE THAT WOULD PRECLUDE THE SAFE PASSAGE OF THE DEVICE, CIRCUMFERENTIAL THROMBUS OR ATHEROMA IN THE SEALING REGIONS, SMALL TARGET VISCERAL VESSELS <4 MM, OR THREE OR MORE RENAL ARTERIES TO A SINGLE, FUNCTIONAL KIDNEY. OVERALL, 35% OF FEMORAL ARTERIES WERE ACCESSED USING A PERCUTANEOUS TECHNIQUE, AND 10% OF THE PATIENTS REQUIRED CONCOMITANT BRACHIAL ACCESS. AVERAGE NUMBER OF VISCERAL ARTERIES STENTED WAS 2.1 6 0.5: 94% OF ALL RENAL ARTERIES WERE STENTED, OF WHICH 17% REQUIRED EXTENSION TO A NONTORTUOUS LANDING ZONE WITH A BARE-METAL STENT. ALL RENAL ARTERIES PERFUSING A FUNCTIONAL KIDNEY WERE STENTED TO PROVIDE A MINIMUM OF 25 MM OF PROXIMAL SEAL ZONE. IF THE RENAL ARTERIES WERE OFFSET SO THAT ONLY ONE REQUIRED STENTING TO PROVIDE THE ADEQUATE SEAL ZONE, A MINIMUM NUMBER OF VISCERAL VESSELS WERE STENTED. OF THE SMAS AND CELIAC ARTERIES, 15% AND 6% WERE STENTED, RESPECTIVELY. OF THE SIX CELIAC ARTERIES STENTED, TWO WERE PERFORMED THROUGH A FENESTRATION IN THE SETTING OF A PREVIOUSLY OCCLUDED SMA AND THE REMAINDER WERE SNORKELED THROUGH A BRACHIAL APPROACH. TECHNICAL SUCCESS, DEFINED AS CASE COMPLETION WITH SUCCESSFUL VISCERAL STENTING, WAS ACHIEVED IN 98% OF OUR PATIENTS. BOTH TECHNICAL FAILURES WERE SECONDARY TO AN INABILITY TO CANNULATE A SINGULAR RENAL ARTERY THROUGH THE MAIN BODY FENESTRATIONS. PERIOPERATIVE (30-DAY) OUTCOMES. MEAN LENGTH OF STAY WAS 3.6 6 4.3 DAYS. MORTALITY AT 30 DAYS WAS 2% IN OUR POPULATION. THE CAUSES OF DEATH IN THESE TWO PATIENTS WERE MYOCARDIAL INFARCTION (MI) AND RENAL FAILURE LEADING TO MULTISYSTEM FAILURE IN ONE PATIENT AND COLONIC ISCHEMIA AND MASSIVE INTRACRANIAL HEMORRHAGE IN AN ANTICOAGULATED PATIENT. THE REINTERVENTION RATE, REGARDLESS OF DISCHARGE DATE, IN THE FIRST 30 DAYS WAS 4%. IN THESE PATIENTS, TWO REQUIRED INTERVENTIONS FOR SUSPECTED MESENTERIC ISCHEMIA; ONE DEVELOPED LIMB ISCHEMIA, AND ANOTHER REQUIRED GROIN DÉBRIDEMENT FOR WOUND BREAKDOWN. IN TERMS OF MORBIDITY, 1% DEVELOPED LIMB OCCLUSION, 2% DEVELOPED VISCERAL STENT THROMBOSIS, AND 3% HAD WOUND COMPLICATIONS, OF WHICH HEMATOMA WAS MOST COMMON. FIVE PATIENTS DEVELOPED MESENTERIC ISCHEMIA IN THE PERIOPERATIVE PERIOD AS DEFINED BY BLOODY DIARRHEA WITH MUCOSAL CHANGES ON SIGMOIDOSCOPY OR COLONOSCOPY. HOWEVER, ONLY TWO PATIENTS REQUIRED SURGICAL INTERVENTION AS THE REMAINING CASES WERE SELF-LIMITED. ONE WAS THE AFOREMENTIONED PATIENT WHO REQUIRED A COLONIC RESECTION AND EVENTUALLY DIED WHEN ANTICOAGULATION RESULTED IN MASSIVE INTRACRANIAL HEMORRHAGE. THE OTHER PATIENT REQUIRED AN SMA STENT FOR A SCALLOP THAT MAY HAVE BEEN ENCROACHING ON THE SMA OSTIA. THERE WAS A 4% MI RATE (ALL NON-ST-SEGMENT ELEVATION MIS) AND 1% STROKE RATE FOR A COMBINED 5% OVERALL INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS. ONE PATIENT DEVELOPED TRANSIENT SPINAL CORD ISCHEMIA THAT RESOLVED BY THE TIME OF THE LATEST FOLLOW-UP. RENAL OUTCOMES: WE FOUND NO DIFFERENCE IN SERUM CREATININE CONCENTRATION BETWEEN THE PREOPERATIVE AND DISCHARGE MEASUREMENTS (1.21 VS 1.20 MG/DL; P ¼ .96). HOWEVER, PATIENTS TENDED TO SEE A PERIOPERATIVE CREATININE BUMP IMMEDIATELY POSTOPERATIVELY AS MAXIMUM CREATININE CONCENTRATION DURING THE INDEX HOSPITALIZATION WAS A MEAN OF 1.47 MG/DL (P < .05). IN ADDITION, THREE PATIENTS REQUIRED HEMODIALYSIS TRANSIENTLY DURING THE FIRST 30 DAYS POSTOPERATIVELY. OVER TIME, WE ALSO NOTED A PROGRESSIVE WORSENING OF RENAL FUNCTION FROM 12 TO 48 MONTHS. IN FACT, FIVE PATIENTS EXPERIENCED RENAL FAILURE REQUIRING HEMODIALYSIS ON FOLLOW-UP; TWO PATIENTS RECOVERED RENAL FUNCTION ENOUGH TO DISCONTINUE RENAL REPLACEMENT THERAPY. AVERAGE DURATION OF FOLLOW-UP WAS 1.7 6 1.4 YEARS. FOURTEEN PATIENTS DIED DURING THE FOLLOW-UP PHASE. AN AVERAGE OF 2.5 CT ANGIOGRAMS OF THE ABDOMEN AND PELVIS WERE PERFORMED ON OUR FEVAR PATIENTS DURING THIS PERIOD. ENDOLEAK WAS PRESENT OR COULD NOT BE EXCLUDED AT THE TIME OF THE LATEST IMAGING MODALITY IN 15% OF THE PATIENTS; TYPE II (60%) WAS THE MOST COMMONLY SUSPECTED TYPE. OF THE 209 IMPLANTED VISCERAL STENTS, THERE WAS A 98% PATENCY RATE AT THE LATEST CLINIC VISIT. TWENTY PATIENTS REQUIRED 29 REINTERVENTIONS DURING THE FOLLOW-UP PHASE, MOST OFTEN FOR ENDOLEAK PERSISTENCE (N ¼ 11), VISCERAL FENESTRATION STENOSIS OR THROMBOSIS (N ¼ 7), OR ACCESS-RELATED COMPLICATIONS (N ¼ 3). OF THOSE WHO REQUIRED REINTERVENTION, EIGHT PATIENTS REQUIRED TWO OR MORE PROCEDURES. WE OBSERVED TWO CASES OF DEATH SECONDARY TO UNDETECTED, ACUTE TYPE III ENDOLEAK BETWEEN THE DISTAL MAIN BODY AND THE PROXIMAL BIFURCATED PIECE LEADING TO RESIDUAL SAC PRESSURIZATION AND RUPTURE. WE BELIEVE THIS WAS SECONDARY TO THE INABILITY TO OVERSIZE THE PROXIMAL END OF THE DISTAL BIFURCATED PIECE IN COMPARISON TO THE DISTAL MAIN BODY. BOTH SECTIONS ARE AVAILABLE ONLY IN A 24-MM PROFILE. FOR THIS REASON, WE ADVOCATE FOR INCREASED SIZE OF THE PROXIMAL DISTAL BIFURCATED PIECE TO MINIMIZE THIS COMPLICATION IN THE FUTURE. IN ADDITION, 29 TOTAL REINTERVENTIONS IN 20 PATIENTS WERE PERFORMED FOR OUR POPULATION, HIGHLIGHTING THE NEED FOR CAREFUL, REGIMENTED FOLLOW-UP OF ALL PATIENTS WHO RECEIVE ZFEN. MORTALITY AT 30 DAYS WAS 2% IN OUR POPULATION. THE CAUSES OF DEATH IN THESE TWO PATIENTS WERE MYOCARDIAL INFARCTION (MI) AND RENAL FAILURE LEADING TO MULTISYSTEM FAILURE IN ONE PATIENT AND COLONIC ISCHEMIA AND MASSIVE INTRACRANIAL HEMORRHAGE IN AN ANTICOAGULATED PATIENT. FROM TABLE V IN ARTICLE: 1 OCCURRENCE OF MESENTERIC ISCHEMIA AND MASSIVE INTRACRANIAL HEMORRHAGE (11 DAYS POST PROCEDURE). 1 OCCURRENCE OF MULTISYSTEM ORGAN FAILURE SECONDARY TO RENAL FAILURE (6 DAYS POST PROCEDURE). THIS (B)(4).: 1 OCCURRENCE OF MULTISYSTEM ORGAN FAILURE SECONDARY TO RENAL FAILURE (6 DAYS POST PROCEDURE). SEE (B)(4) FOR: 1 OCCURRENCE OF MESENTERIC ISCHEMIA AND MASSIVE INTRACRANIAL HEMORRHAGE (11 DAYS POST PROCEDURE). ALL RELATED PR¿S (B)(4): EARLY (THIRTY-DAY) MORTALITY - MESENTERIC ISCHEMIA AND MASSIVE INTRACRANIAL HEMORRHAGE. (B)(4): MORTALITY RELATED TYPE III ENDOLEAK. (B)(4): LATE (PAST 30 DAYS) MORTALITY. (B)(4): ADVERSE PHYSIOLOGICAL RESPONSE. (B)(4): UNKNOWN ENDOLEAK. (B)(4): EARLY (THIRTY-DAY) MORTALITY - MULTISYSTEM ORGAN FAILURE SECONDARY TO RENAL FAILURE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703684 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 Death