ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2023-00060
- Event Type
- Injury
- Date Received
- July 3, 2023
- Report Date
- September 1, 2023
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SHAHVERDYAN R, MAJD MP, THUL R, BRAUN N, GAWENDA M, BRUNKWALL J. F-EVAR DOES NOT IMPAIR RENAL FUNCTION MORE THAN OPEN SURGERY FOR JUXTARENAL AORTIC ANEURYSMS: SINGLE CENTRE RESULTS. EUR J VASC ENDOVASC SURG. 2015;50(4):432-441. DOI:10.1016/J.EJVS.2015.04.028 (B)(4) ARE RELATED.
THE INITIAL SUBMISSION COVERED 6 CASES OF ADVERSE EVENTS. THIS HAS BEEN UPDATED AS INVESTIGATION REQUIRED SOME EVENTS TO BE INVESTIGATED SEPARATELY. THE EVENTS THAT HAVE BEEN INVESTIGATED SEPARATELY ARE REPORTED UNDER THE FOLLOWING PRS: - (B)(4): THREE PATIENTS HAD A PERSISTENT LONG-TERM RENAL INSUFFICIENCY; ONE OF WHOM WITH PRE-EXISTING CHRONIC RENAL INSUFFICIENCY AND PRE-OPERATIVE CREATININE LEVEL OF 335.9 MMOL/L REQUIRED HAEMODIALYSIS 1.5 YEARS LATER. THE MEDIAN EGFR WAS 70 ML/MIN (RANGE 16-116). THIS IS A FINAL REPORT THAT COVERS 3 CASES OF LATE LIMB OCCLUSIONS: 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. POSSIBLE ROOT CAUSES INCLUDE: - ROUGH SURFACE PRONE TO THROMBUS FORMATION - INADEQUATE MEDICATION OF PATIENT WITH ANTICOAGULANTS - PATIENT FACTORS SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION MAY BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUPPLIED.
PROSPECTIVELY COLLECTED DATA OF PATIENTS UNDERGOING ELECTIVE OPEN (OSR) OR FENESTRATED ENDOVASCULAR REPAIR (F-EVAR) OF JUXTARENAL AORTIC ANEURYSM (JAA) BETWEEN APRIL 1999 AND JULY 2014 WERE ANALYSED RETROSPECTIVELY. ALL SYMPTOMATIC, MYCOTIC, INFLAMMATORY, AND RUPTURED ANEURYSMS WERE EXCLUDED. THE DEFINITION OF JAA WAS BASED ON THE SHORT NECKED AAA, IF THE CROSS CLAMPING (CC) WAS NEEDED ABOVE ONE OR BOTH RENAL ARTERIES IN THE OSR GROUP. THE CHOICE FOR F-EVAR WAS BASED ON A SHORT INFRARENAL ANEURYSM NECK OF LESS THAN OR EQUAL TO 10 MM. PRE-OPERATIVE IMAGING WAS PERFORMED USING CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CTA) WITH LESS THAN OR EQUAL TO 1.5 MM SLICES FROM THE NECK TO THE GROINS. ALL PATIENTS UNDERWENT ECHOCARDIOGRAPHY, LUNG FUNCTION SPIROMETRY, OR CORONARY ANGIOGRAM WHEN NECESSARY. INDIVIDUAL RISK FACTORS AND COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION (PATIENTS TAKING ONE OR MORE ANTIHYPERTENSIVE MEDICATIONS), HISTORY OF MYOCARDIAL INFARCTION, CORONARY HEART DISEASE (CURRENT ANGINA AND/OR HISTORY OF PREVIOUS CORONARY INTERVENTIONS SUCH AS ANGIOPLASTY OR CORONARY ARTERY BYPASS GRAFT), CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PERIPHERAL ARTERIAL DISEASE (HISTORY OF PREVIOUS INTERVENTIONS SUCH AS ANGIOPLASTY OR BYPASS-SURGERY; CURRENT FONTAINE STAGES I-IV AND/OR REDUCTION OF ANKLE BRACHIAL INDEX <0.8), DIABETES MELLITUS, HEART INSUFFICIENCY (LIMITATIONS OF ACTIVITY ACCORDING TO NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION AND/OR REDUCTION OF EJECTION FRACTION <30%), AND RENAL INSUFFICIENCY (CURRENT CREATININE LEVEL >141 MMOL/L WITH OR WITHOUT THE NEED OF DIALYSIS). THE PATIENTS WERE OFFERED EITHER OSR OR F-EVAR AND MADE THEIR CHOICE AFTER THEY WERE INFORMED ABOUT THE RISKS AND HAD COMPLETED A WRITTEN CONSENT FORM FOR THE SELECTED PROCEDURE. EARLY IN THE SERIES, RENAL ARTERY STENOSIS WAS AN EXCLUSION CRITERION FOR PATIENTS IN THE F-EVAR GROUP BECAUSE OF EXPECTED DIFFICULTIES WITH CANNULATION; HOWEVER, THIS IS NO LONGER CONSIDERED TO BE A CONTRAINDICATION. F-EVAR. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANAESTHESIA IN THE HYBRID OPERATING ROOM WITH A CEILING MOUNTED ANGIOGRAPHIC C-ARM SYSTEM BY THE SAME SURGEONS (J.B./M.G.). INITIALLY, THE ZENITH STENT GRAFT WAS IMPLANTED BECAUSE IT WAS THE ONLY COMMERCIALLY AVAILABLE PRODUCT. WHEN THE ANACONDA STENT GRAFT BECAME AVAILABLE IT WAS ALSO USED, WITH GOOD RESULTS AND OFFERING THE POSSIBILITY OF REPOSITIONING AND GOOD CLARITY OF THE ORIFICES OF THE FENESTRATIONS. AFTER THAT, THE DECISION ON WHICH STENT GRAFT WAS IMPLANTED WAS MADE BY THE MAIN SURGEON. AFTER 70-100 U/KG OF HEPARIN WERE ADMINISTERED, THE CFAS WERE PUNCTURED AND CANNULATED EITHER PERCUTANEOUSLY OR BY OPEN FEMORAL ACCESS, DEPENDING ON THE SURGEON¿S PREFERENCE AND PATIENT¿S HABITUS. AFTER THE MAIN BODY WAS INSERTED AND THE FENESTRATIONS WERE CANNULATED AND STENTED THROUGH A 20F SHEATH FROM BELOW, THE ADVANTA V12 STENT GRAFTS (ATRIUM, HUDSON, NH, USA) WERE FLARED IN THE PROXIMAL THIRD BY A 10 MM BALLOON TO GIVE A SAFE SEAL. THE ILIAC EXTENSIONS WERE PLACED IN A STANDARD FASHION. FOR PATIENTS WITH AORTO-ILIAC ANEURYSM (AIAA) AND A DISTAL LANDING ZONE IN THE EXTERNAL ILIAC ARTERY (EIA), THE BODY OF THE COOK ZENITH ILIAC SIDEBRANCHED GRAFT (ISBG) (COOK INC., BLOOMINGTON, IN, USA) WAS PLACED IN THE CIA AND EIA PRIOR TO THE BRIDGING AND CONTRALATERAL ILIAC LEG AS PREVIOUSLY DESCRIBED. A COMPLETION ANGIOGRAM WAS DONE TO CONFIRM PATENCY AND NO ENDOLEAK. AFTER WITHDRAWAL OF THE DEVICES, THE INCISIONS WERE CLOSED IN ANATOMICAL LAYERS. IF A PERCUTANEOUS APPROACH WAS PERFORMED, THE FASCIA CLOSURE TECHNIQUE WAS APPLIED AS DESCRIBED. CEREBROSPINAL FLUID DRAINAGE (CSFD) WAS NOT USED ROUTINELY. THE PRIMARY ENDPOINT WAS ANEURYSM OR PROCEDURE RELATED MORTALITY, AND THE SECONDARY ENDPOINT WAS PERI-OPERATIVE RENAL INSUFFICIENCY (CHANGE IN BASELINE SERUM CREATININE LEVEL AS WELL AS ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) ACCORDING TO THE COCKCROFT-GAULT EQUATION13 BETWEEN BEFORE SURGERY, ON THE FIRST POST-OPERATIVE DAY, PREDISCHARGE, AND LAST ACQUIRED VALUE). A POST-OPERATIVE RISE OF BASELINE CREATININE BY >50% AND/OR DETERIORATION OF EGFR BY 25% WITHIN 1 WEEK WERE DEFINED AS RENAL FAILURE. TECHNICAL SUCCESS FOR F-EVAR WAS DEFINED AS A COMPLETELY EXCLUDED ANEURYSM WITHOUT ABANDONMENT/CONVERSION OF THE PROCEDURE OR INTRA-OPERATIVE MORTALITY, WITH SUCCESSFUL GRAFTS TO OR CANNULATION OF TARGET VESSELS AS WELL AS THEIR PATENCY, AND NO SIGNS OF TYPE I OR III ENDOLEAK. THE PRE-DISCHARGE POST-OPERATIVE FOLLOW UP INCLUDED CTA AND/OR DUPLEX ULTRASOUND, DEPENDING ON RENAL FUNCTION, AND FOLLOW UPS WERE THEN AT 6 AND 12 MONTHS, AND ANNUALLY THEREAFTER. INTERMEDIATE TERM RESULTS WERE ANALYSED, COMPARED, AND REPORTED FOR UP TO 2 YEARS FOR BOTH GROUPS. OF THE 35 PATIENTS WHO UNDERWENT F-EVAR, THERE WERE NINE PATIENTS HAD THE ZENITH FENESTRATED GRAFT IMPLANTED AND 26 PATIENTS HAD THE ANACONDA CMD GRAFT IMPLANTED. F-EVAR. FOUR PATIENTS HAD AN AIAA, ONE OF WHOM WAS TREATED WITH COILING AND OVERSTENTING OF THE RIGHT IIA WHILE THE OTHER THREE WERE GIVEN A COOK ISBG. ONE PATIENT WITH A DIAMETER OF INFRARENAL AORTA OF 36 MM HAD AN AORTO-ILIAC ANEURYSM, WHERE THE MAIN INDICATION WAS AN ANEURYSM OF THE LEFT CIA OF 32 MM. CSF-D WAS USED IN FIVE PATIENTS WITH HIGHER RISK OF SPINAL CORD ISCHEMIA (SCI), BASED ON THE PATIENTS¿ INDIVIDUAL CHARACTERISTICS, SUCH AS SPINAL COLUMN ANATOMY, PATENT VERTEBRAL AND/OR IIA OR ANTICOAGULATION TAKEN, AS WELL AS NUMBER OF FENESTRATIONS NEEDED. THIRTY-ONE PATIENTS WERE TAKING ANTIPLATELET DRUGS, EITHER ASPIRIN 100 MG/D OR CLOPIDOGREL 75 MG/D, THREE WERE TAKING PHENPROCOUMON, AND ONE WAS TAKING THE FACTOR XA INHIBITOR RIVAROXABAN. F-EVAR. THERE WERE NO CONVERSIONS, AORTIC DISSECTIONS, OR PERIPHERAL EMBOLIZATIONS. THE PRIMARY TECHNICAL SUCCESS WAS 94.3% (33/35). F-EVAR. IN 30 CASES THE MAIN BODY ACCESS SITE WAS THE RIGHT GROIN, AND IN FIVE CASES THE LEFT GROIN. THIRTY-ONE PROCEDURES WERE PERFORMED BY FEMORAL CUTDOWN, AND FOUR PERCUTANEOUSLY. THREE PATIENTS HAD FOUR FENESTRATIONS, 11 PATIENTS HAD THREE, 19 PATIENTS HAD TWO, AND THE FINAL TWO PATIENTS HAD ONE FENESTRATION EACH. ALL PATIENTS WERE MONITORED OVERNIGHT POST-OPERATIVELY IN THE INTENSIVE/INTERMEDIATE CARE UNIT. THIS (B)(4) : THIS PR COVERS 6 CASES OF LATE ADVERSE PHYSIOLOGICAL RESPONSES. - THREE PATIENTS HAD LIMB OCCLUSION AT 3, 9, AND 20 MONTHS, RESPECTIVELY, TREATED SUCCESSFULLY WITH OPEN SURGERY. - THREE PATIENTS HAD A PERSISTENT LONG-TERM RENAL INSUFFICIENCY; ONE OF WHOM WITH PRE-EXISTING CHRONIC RENAL INSUFFICIENCY AND PRE-OPERATIVE CREATININE LEVEL OF 335.9 MMOL/L REQUIRED HAEMODIALYSIS 1.5 YEARS LATER. THE MEDIAN EGFR WAS 70 ML/MIN (RANGE 16-116). NB! OF THE 35 PATIENTS WHO UNDERWENT F-EVAR, THERE WERE NINE PATIENTS HAD THE ZENITH FENESTRATED GRAFT IMPLANTED AND 26 PATIENTS HAD THE ANACONDA CMD GRAFT IMPLANTED. ALTHOUGH NOT ALL PATIENTS WILL HAVE HAD THE ZENITH FENESTRATED GRAFT IMPLANTED, A RECORD HAS BEEN OPENED AS IT CANNOT BE DETERMINED WHICH ADVERSE EVENTS OF THE ONES REPORTED, THAT THEY EXPERIENCED WITH A ZFEN.
PROSPECTIVELY COLLECTED DATA OF PATIENTS UNDERGOING ELECTIVE OPEN (OSR) OR FENESTRATED ENDOVASCULAR REPAIR (F-EVAR) OF JUXTARENAL AORTIC ANEURYSM (JAA) BETWEEN APRIL 1999 AND JULY 2014 WERE ANALYSED RETROSPECTIVELY. ALL SYMPTOMATIC, MYCOTIC, INFLAMMATORY, AND RUPTURED ANEURYSMS WERE EXCLUDED. THE DEFINITION OF JAA WAS BASED ON THE SHORT NECKED AAA, IF THE CROSS CLAMPING (CC) WAS NEEDED ABOVE ONE OR BOTH RENAL ARTERIES IN THE OSR GROUP. THE CHOICE FOR F-EVAR WAS BASED ON A SHORT INFRARENAL ANEURYSM NECK OF LESS THAN OR EQUAL TO 10 MM. PRE-OPERATIVE IMAGING WAS PERFORMED USING CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CTA) WITH LESS THAN OR EQUAL TO 1.5 MM SLICES FROM THE NECK TO THE GROINS. ALL PATIENTS UNDERWENT ECHOCARDIOGRAPHY, LUNG FUNCTION SPIROMETRY, OR CORONARY ANGIOGRAM WHEN NECESSARY. INDIVIDUAL RISK FACTORS AND COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION (PATIENTS TAKING ONE OR MORE ANTIHYPERTENSIVE MEDICATIONS), HISTORY OF MYOCARDIAL INFARCTION, CORONARY HEART DISEASE (CURRENT ANGINA AND/OR HISTORY OF PREVIOUS CORONARY INTERVENTIONS SUCH AS ANGIOPLASTY OR CORONARY ARTERY BYPASS GRAFT), CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PERIPHERAL ARTERIAL DISEASE (HISTORY OF PREVIOUS INTERVENTIONS SUCH AS ANGIOPLASTY OR BYPASS-SURGERY; CURRENT FONTAINE STAGES I-IV AND/OR REDUCTION OF ANKLE BRACHIAL INDEX <0.8), DIABETES MELLITUS, HEART INSUFFICIENCY (LIMITATIONS OF ACTIVITY ACCORDING TO NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION AND/OR REDUCTION OF EJECTION FRACTION <30%), AND RENAL INSUFFICIENCY (CURRENT CREATININE LEVEL >141 MMOL/L WITH OR WITHOUT THE NEED OF DIALYSIS). THE PATIENTS WERE OFFERED EITHER OSR OR F-EVAR AND MADE THEIR CHOICE AFTER THEY WERE INFORMED ABOUT THE RISKS AND HAD COMPLETED A WRITTEN CONSENT FORM FOR THE SELECTED PROCEDURE. EARLY IN THE SERIES, RENAL ARTERY STENOSIS WAS AN EXCLUSION CRITERION FOR PATIENTS IN THE F-EVAR GROUP BECAUSE OF EXPECTED DIFFICULTIES WITH CANNULATION; HOWEVER, THIS IS NO LONGER CONSIDERED TO BE A CONTRAINDICATION. F-EVAR. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANAESTHESIA IN THE HYBRID OPERATING ROOM WITH A CEILING MOUNTED ANGIOGRAPHIC C-ARM SYSTEM BY THE SAME SURGEONS (J.B./M.G.). INITIALLY, THE ZENITH STENT GRAFT WAS IMPLANTED BECAUSE IT WAS THE ONLY COMMERCIALLY AVAILABLE PRODUCT. WHEN THE ANACONDA STENT GRAFT BECAME AVAILABLE IT WAS ALSO USED, WITH GOOD RESULTS AND OFFERING THE POSSIBILITY OF REPOSITIONING AND GOOD CLARITY OF THE ORIFICES OF THE FENESTRATIONS. AFTER THAT, THE DECISION ON WHICH STENT GRAFT WAS IMPLANTED WAS MADE BY THE MAIN SURGEON. AFTER 70-100 U/KG OF HEPARIN WERE ADMINISTERED, THE CFAS WERE PUNCTURED AND CANNULATED EITHER PERCUTANEOUSLY OR BY OPEN FEMORAL ACCESS, DEPENDING ON THE SURGEON¿S PREFERENCE AND PATIENT¿S HABITUS. AFTER THE MAIN BODY WAS INSERTED AND THE FENESTRATIONS WERE CANNULATED AND STENTED THROUGH A 20F SHEATH FROM BELOW, THE ADVANTA V12 STENT GRAFTS (ATRIUM, HUDSON, NH, USA) WERE FLARED IN THE PROXIMAL THIRD BY A 10 MM BALLOON TO GIVE A SAFE SEAL. THE ILIAC EXTENSIONS WERE PLACED IN A STANDARD FASHION. FOR PATIENTS WITH AORTO-ILIAC ANEURYSM (AIAA) AND A DISTAL LANDING ZONE IN THE EXTERNAL ILIAC ARTERY (EIA), THE BODY OF THE COOK ZENITH ILIAC SIDEBRANCHED GRAFT (ISBG) (COOK INC., BLOOMINGTON, IN, USA) WAS PLACED IN THE CIA AND EIA PRIOR TO THE BRIDGING AND CONTRALATERAL ILIAC LEG AS PREVIOUSLY DESCRIBED. A COMPLETION ANGIOGRAM WAS DONE TO CONFIRM PATENCY AND NO ENDOLEAK. AFTER WITHDRAWAL OF THE DEVICES, THE INCISIONS WERE CLOSED IN ANATOMICAL LAYERS. IF A PERCUTANEOUS APPROACH WAS PERFORMED, THE FASCIA CLOSURE TECHNIQUE WAS APPLIED AS DESCRIBED. CEREBROSPINAL FLUID DRAINAGE (CSFD) WAS NOT USED ROUTINELY. THE PRIMARY ENDPOINT WAS ANEURYSM OR PROCEDURE RELATED MORTALITY, AND THE SECONDARY ENDPOINT WAS PERI-OPERATIVE RENAL INSUFFICIENCY (CHANGE IN BASELINE SERUM CREATININE LEVEL AS WELL AS ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) ACCORDING TO THE COCKCROFT-GAULT EQUATION13 BETWEEN BEFORE SURGERY, ON THE FIRST POST-OPERATIVE DAY, PREDISCHARGE, AND LAST ACQUIRED VALUE). A POST-OPERATIVE RISE OF BASELINE CREATININE BY >50% AND/OR DETERIORATION OF EGFR BY 25% WITHIN 1 WEEK WERE DEFINED AS RENAL FAILURE. TECHNICAL SUCCESS FOR F-EVAR WAS DEFINED AS A COMPLETELY EXCLUDED ANEURYSM WITHOUT ABANDONMENT/CONVERSION OF THE PROCEDURE OR INTRA-OPERATIVE MORTALITY, WITH SUCCESSFUL GRAFTS TO OR CANNULATION OF TARGET VESSELS AS WELL AS THEIR PATENCY, AND NO SIGNS OF TYPE I OR III ENDOLEAK. THE PRE-DISCHARGE POST-OPERATIVE FOLLOW UP INCLUDED CTA AND/OR DUPLEX ULTRASOUND, DEPENDING ON RENAL FUNCTION, AND FOLLOW UPS WERE THEN AT 6 AND 12 MONTHS, AND ANNUALLY THEREAFTER. INTERMEDIATE TERM RESULTS WERE ANALYSED, COMPARED, AND REPORTED FOR UP TO 2 YEARS FOR BOTH GROUPS. OF THE 35 PATIENTS WHO UNDERWENT F-EVAR, THERE WERE NINE PATIENTS HAD THE ZENITH FENESTRATED GRAFT IMPLANTED AND 26 PATIENTS HAD THE ANACONDA CMD GRAFT IMPLANTED. F-EVAR. FOUR PATIENTS HAD AN AIAA, ONE OF WHOM WAS TREATED WITH COILING AND OVERSTENTING OF THE RIGHT IIA WHILE THE OTHER THREE WERE GIVEN A COOK ISBG. ONE PATIENT WITH A DIAMETER OF INFRARENAL AORTA OF 36 MM HAD AN AORTO-ILIAC ANEURYSM, WHERE THE MAIN INDICATION WAS AN ANEURYSM OF THE LEFT CIA OF 32 MM. CSF-D WAS USED IN FIVE PATIENTS WITH HIGHER RISK OF SPINAL CORD ISCHEMIA (SCI), BASED ON THE PATIENTS¿ INDIVIDUAL CHARACTERISTICS, SUCH AS SPINAL COLUMN ANATOMY, PATENT VERTEBRAL AND/OR IIA OR ANTICOAGULATION TAKEN, AS WELL AS NUMBER OF FENESTRATIONS NEEDED. THIRTY-ONE PATIENTS WERE TAKING ANTIPLATELET DRUGS, EITHER ASPIRIN 100 MG/D OR CLOPIDOGREL 75 MG/D, THREE WERE TAKING PHENPROCOUMON, AND ONE WAS TAKING THE FACTOR XA INHIBITOR RIVAROXABAN. F-EVAR. THERE WERE NO CONVERSIONS, AORTIC DISSECTIONS, OR PERIPHERAL EMBOLIZATIONS. THE PRIMARY TECHNICAL SUCCESS WAS 94.3% (33/35). F-EVAR. IN 30 CASES THE MAIN BODY ACCESS SITE WAS THE RIGHT GROIN, AND IN FIVE CASES THE LEFT GROIN. THIRTY-ONE PROCEDURES WERE PERFORMED BY FEMORAL CUTDOWN, AND FOUR PERCUTANEOUSLY. THREE PATIENTS HAD FOUR FENESTRATIONS, 11 PATIENTS HAD THREE, 19 PATIENTS HAD TWO, AND THE FINAL TWO PATIENTS HAD ONE FENESTRATION EACH. ALL PATIENTS WERE MONITORED OVERNIGHT POST-OPERATIVELY IN THE INTENSIVE/INTERMEDIATE CARE UNIT. THIS (B)(4): THIS PR COVERS 3 CASES OF LATE ADVERSE PHYSIOLOGICAL RESPONSES. - THREE PATIENTS HAD LIMB OCCLUSION AT 3, 9, AND 20 MONTHS, RESPECTIVELY, TREATED SUCCESSFULLY WITH OPEN SURGERY. NB! OF THE 35 PATIENTS WHO UNDERWENT F-EVAR, THERE WERE NINE PATIENTS HAD THE ZENITH FENESTRATED GRAFT IMPLANTED AND 26 PATIENTS HAD THE ANACONDA CMD GRAFT IMPLANTED. ALTHOUGH NOT ALL PATIENTS WILL HAVE HAD THE ZENITH FENESTRATED GRAFT IMPLANTED, A RECORD HAS BEEN OPENED AS IT CANNOT BE DETERMINED WHICH ADVERSE EVENTS OF THE ONES REPORTED, THAT THEY EXPERIENCED WITH A ZFEN. PATIENT OUTCOME: FOLLOW UPS WERE AT 6 AND 12 MONTHS, AND ANNUALLY THEREAFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612824 | 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 | Required Intervention |