ZENITH FENESTRATED GRAFT
Report
- Report Number
- 9680654-2023-00140
- Event Type
- Injury
- Date Received
- November 20, 2023
- Report Date
- December 13, 2023
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT INFORMATION TAKEN FROM: CHONG LI ET AL 2023: "ABDOMINAL AORTIC ANEURYSM NECK DILATATION AND SAC REMODELING IN FENESTRATED COMPARED TO STANDARD ENDOVASCULAR AORTIC REPAIR". DOI: 10.1177/17085381211052802. NO INFORMATION REGARDING THE DETAILS OF RE INTERVENTION WERE SUPPLIED.
NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. NO IMAGING WAS RECEIVED TO ASSIST THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, DESPITE MAKING 3 REQUESTS; NO ADDITIONAL INFORMATION WAS PROVIDED. REVIEW OF DEVICE HISTORY RECORD WAS NOT ABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN, THEREFORE MANUFACTURING RECORDS COULD NOT BE REVIEWED. 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 IT 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: - ANESTHETIC COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ASPIRATION) - ANEURYSM ENLARGEMENT - ANEURYSM RUPTURE AND DEATH - AORTIC DAMAGE, INCLUDING PERFORATION, DISSECTION, BLEEDING, RUPTURE AND DEATH - ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDOANEURYSM - ENDOLEAK - PULMONARY/RESPIRATORY COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., PNEUMONIA, RESPIRATORY FAILURE, PROLONGED INTUBATION) - RENAL COMPLICATIONS AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., ARTERY STENOSIS OR OCCLUSION, CONTRAST TOXICITY, INFARCT, INSUFFICIENCY, FAILURE) - EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION 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. BASED ON THE INFORMATION RECEIVED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. THERE ARE MANY POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION 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 WAS TAKEN FROM REVIEW OF A JOURNAL ARTICLE: CHONG LI ET AL: ABDOMINAL AORTIC ANEURYSM NECK DILATATION AND SAC REMODELING IN FENESTRATED COMPARED TO STANDARD ENDOVASCULAR AORTIC REPAIR. DOI: 2023;31(1):3-9. DOI:10.1177/17085381211052802 NOTE: GIVEN THAT MULTIPLE PAPERS CAN BE ADDRESSING THE SAME COHORT OF PATIENTS, DUPLICATES OF THE DATA MAY BE REPORTED AND THEREFORE THESE NUMBERS CAN BE OVERESTIMATING THE EVENTS.
CHONG LI ET AL: ABDOMINAL AORTIC ANEURYSM NECK DILATATION AND SAC REMODELING IN FENESTRATED COMPARED TO STANDARD ENDOVASCULAR AORTIC REPAIR. A RETROSPECTIVE REVIEW OF PROSPECTIVELY COLLECTED DATA ON 20 CONSECUTIVE FEVAR PATIENTS (COOK ZENITH® FENESTRATED) AND 20 SEVAR (COOK ZENITH®) PATIENTS WAS PERFORMED. DEMOGRAPHIC DATA, ANATOMIC CHARACTERISTICS, PROCEDURAL DETAILS, AND CLINICAL OUTCOME WERE ANALYZED. PRE-OPERATIVE, POST-OPERATIVE (1 MONTH), AND LONGEST FOLLOW-UP CT SCAN AT AN AVERAGE OF 29.3 MONTHS FOR FEVAR AND 29.8 MONTHS FOR SEVAR WERE ANALYZED USING A DEDICATED 3D WORKSTATION (INTUITION, TERARECON INC, FOSTER CITY, CALIFORNIA). ABDOMINAL AORTIC ANEURYSM NECK DIAMETER WAS MEASURED IN 5 MM INCREMENTS, RANGING FROM 20 MM ABOVE TO 20 MM BELOW THE LOWEST RENAL ARTERY. SUB-ANALYSIS COMPARING THE FEVAR TO THE SEVAR GROUP AT 12 MONTHS AND AT GREATER THAN 30 MONTHS WAS PERFORMED. STANDARD STATISTICAL ANALYSIS WAS DONE. DEMOGRAPHIC CHARACTERISTICS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO COHORTS. THE FEVAR GROUP HAD A LARGER MEAN AORTIC DIAMETER AT THE LOWEST RENAL ARTERY, SHORTER INFRARENAL AORTIC NECK LENGTH, INCREASED PREVALENCE OF NONPARALLEL NECK SHAPE, AND LONGER AAA LENGTH. ON FOLLOW-UP IMAGING, THE SUPRARENAL AORTIC SEGMENT DILATED SIGNIFICANTLY MORE AT ALL LOCATIONS IN THE FEVAR COHORT, WHEREAS THE INFRARENAL AORTIC NECK SEGMENT DILATED SIGNIFICANTLY LESS COMPARED TO THE SEVAR GROUP. COMPARED TO THE SEVAR COHORT, THE FEVAR PATIENTS DEMONSTRATED SIGNIFICANTLY GREATER POSITIVE SAC REMODELING AS EVIDENT BY MORE SAC DIAMETER REGRESSION, AND ELONGATION OF DISTANCE MEASURED FROM THE CELIAC AXIS TO THE MOST CEPHALAD MARGIN OF THE SAC. DEVICE MIGRATION, ENDOLEAK OCCURRENCE, RE-INTERVENTION RATE, AND MORTALITIES WERE SIMILAR IN BOTH GROUPS. FROM 2013 TO 2019, 76 PATIENTS WITH AAA WERE TREATED WITH FEVAR AND 213 PATIENTS WERE TREATED WITH SEVAR. INDICATIONS FOR REPAIR SUCH AS DIAMETER, GROWTH RATE >5 MM OVER 6 MONTHS, SYMPTOMATIC STATUS, AND CONCURRENT ILIAC ANEURYSM WERE BASED ON DISCRETION OF THE TREATING PHYSICIAN. INSTRUCTIONS FOR USE FROM THE MANUFACTURER WERE FOLLOWED, SPECIFICALLY WITH FEVAR USED FOR PATIENTS WITH SHORT INFRARENAL AORTIC NECK OF AT LEAST 4 MM, AND SEVAR FOR THOSE WITH NECK 15 MM OR GREATER. PARALLEL BRANCH EVAR OR PHYSICAN-MODIFIED EVAR CASES WERE EXCLUDED. ONLY PATIENTS WITH AVAILABLE PREOPERATIVE, 1-MONTH POST-OPERATIVE, AND MINIMUM 1-YEAR FOLLOW-UP COMPUTER TOMOGRAPHY ANGIOGRAM (CTA) WERE INCLUDED IN THIS STUDY. TWENTY CONSECUTIVE PATIENTS MEETING THE ABOVE INCLUSION CRITERIA TREATED USING FEVAR (ZENITH® FENESTRATED ENDOGRAFT, COOK, BLOOMINGTON, INDIANA) WERE COMPARED TO 20 CONSECUTIVE PATIENTS TREATED USING SEVAR (ZENITH® ENDOGRAFT, COOK, BLOOMINGTON, INDIANA). PRE-OPERATIVE, 1-MONTH POST-OPERATIVE, AND THE LONGEST AVAILABLE FOLLOW-UP CTA AT AN AVERAGE OF 29.3 MONTHS FOR FEVAR AND 29.8 MONTHS FOR SEVAR WERE ANALYZED USING A DEDICATED 3D WORKSTATION (INTUITION, TERARECON INC, FOSTER CITY, CALIFORNIA). BASELINE DEMOGRAPHIC AND RADIOGRAPHIC CHARACTERISTICS, PROCEDURAL DETAILS, AND CLINICAL OUTCOMES WERE ABSTRACTED AND ANALYZED. THE PRIMARY OUTCOME WAS CHANGED IN SUPRARENAL AND INFRARENAL AORTIC NECK DILATATION, AS WELL AS THE CHANGE IN THE MAXIMUM SAC DIAMETER IN THE FEVAR GROUP AND THE SEVAR GROUP OVER TIME. SECONDARY RADIOGRAPHIC OUTCOMES INCLUDED CHANGES OVER TIME IN THE DISTANCE BETWEEN CELIAC ARTERY TO THE PROXIMAL EXTENT OF THE ANEURYSM, A SURROGATE FOR SAC REMODELING, AS WELL AS CELIAC ARTERY TO THE TOP OF GRAFT FABRIC, AN ESTIMATE FOR GRAFT MIGRATION. SECONDARY CLINICAL OUTCOMES INCLUDED TYPE 2 ENDOLEAK, DEVICE-RELATED RE-INTERVENTION AND ALL-CAUSE MORTALITY. INFRARENAL AORTIC NECK LENGTH, MORPHOLOGY, DEGREE OF THROMBUS, AND CALCIFICATION WERE ASSESSED BASED ON THE PREOPERATIVE CTA. NONPARALLEL NECK SHAPE WAS DEFINED AS CHANGE IN NECK DIAMETER >10% IN PROXIMAL LANDING ZONE. SEVERE NECK THROMBUS WAS DEFINED AS CIRCUMFERENTIAL THROMBUS OR GREATEST THICKNESS OF 5 MM OR GREATER. SEVERE NECK CALCIFICATION WAS DEFINED AS CIRCUMFERENTIAL CALCIFICATION OR GREATEST THICKNESS OF 3 MM OR GREATER. MEAN DEVICE OVERSIZING WAS CALCULATED FROM (DEVICE DIAMETER ¿ AVERAGE PROXIMAL LANDING ZONE DIAMETER) AVERAGE PROXIMAL LANDING ZONE DIAMETER, USING THE PRE-OPERATIVE CTA. ALL DIAMETERS AND LENGTHS WERE PRESENTED AS PERCENT CHANGE OVER TIME; THIS WAS CALCULATED BY TAKING THE ABSOLUTE DIFFERENCE BETWEEN THE FOLLOW-UP CTA MEASUREMENT AND THE 1-MONTH (BASELINE) POST-OPERATIVE CTA MEASUREMENT, AND DIVIDING THIS BY THE 1-MONTH POST-OPERATIVE CTA MEASUREMENT. THE AVERAGE ABSOLUTE CHANGES IN DIAMETER OR DISTANCE WERE ALSO MEASURED. THE DIFFERENCE IN CATEGORICAL VARIABLES AND FREQUENCIES BETWEEN THE FEVAR AND SEVAR GROUPS WAS ANALYZED USING FISHER¿S EXACT TEST. DIFFERENCE IN CONTINUOUS VARIABLES BETWEEN THE TWO GROUPS WAS ANALYZED USING STUDENT¿S T TEST. DIFFERENCE WAS CONSIDERED AS STATISTICALLY SIGNIFICANT FOR P VALUES < 0.05 (TWO SIDED). STATISTICAL ANALYSES WERE PERFORMED BY USING SPSS SOFTWARE (VERSION 25.0, IBM CORP, ARMONK, NY). NEARLY ALL OF THE SUPRARENAL AORTIC SEGMENTS DILATED SIGNIFICANTLY MORE IN THE FEVAR GROUP COMPARED TO THE SEVAR GROUP (P < 0.05). ON THE CONTRARY, THE INFRARENAL AORTIC NECK SEGMENTS DILATED SIGNIFICANTLY LESS IN THE FEVAR GROUP COMPARED TO THE SEVAR GROUP. THE FEVAR GROUP DEMONSTRATED GREATER SAC REGRESSION AND REMODELING, AS EVIDENT BY THE DECREASE IN MAXIMUM SAC DIAMETER (-15.7% VS -4.9%, P = 0.04), AND THE INCREASE IN THE DISTANCE FROM THE CELIAC AXIS TO THE MOST CEPHALAD MARGIN OF THE SAC (29.9% VS 3.4%, P = 0.017). THE DISTANCE FROM CELIAC ARTERY TO THE TOP OF GRAFT FABRIC, A SURROGATE FOR DEVICE MIGRATION, DID NOT DIFFER BETWEEN THE TWO GROUPS. 30% OF THE SEVAR GROUP HAD TWO CONSECUTIVE SEGMENTS THAT DILATED BEYOND THE STENT GRAFT DIAMETER, WHEREAS THIS WAS FOUND IN 50% OF THE FEVAR COHORT. CLINICAL OUTCOMES SUCH AS TYPE 1A OR TYPE 2 ENDOLEAK OCCURRENCE, DEVICE-RELATED RE-INTERVENTION, AND MORTALITY WERE SIMILAR IN BOTH GROUPS, AT AN AVERAGE OF 29.3 AND 29.8 MONTHS OF FOLLOW-UP, RESPECTIVELY. THIS (B)(4): DEVICE-RELATED RE-INTERVENTION RATE OF 10% IN FEVAR GROUP (N = 2). RELATED PR: (B)(4): ALL CAUSE MORTALITY RATE OF 10% IN FEVAR GROUP.
CHONG LI ET AL: ABDOMINAL AORTIC ANEURYSM NECK DILATATION AND SAC REMODELING IN FENESTRATED COMPARED TO STANDARD ENDOVASCULAR AORTIC REPAIR. A RETROSPECTIVE REVIEW OF PROSPECTIVELY COLLECTED DATA ON 20 CONSECUTIVE FEVAR PATIENTS (COOK ZENITH® FENESTRATED) AND 20 SEVAR (COOK ZENITH®) PATIENTS WAS PERFORMED. DEMOGRAPHIC DATA, ANATOMIC CHARACTERISTICS, PROCEDURAL DETAILS, AND CLINICAL OUTCOME WERE ANALYZED. PRE-OPERATIVE, POST-OPERATIVE (1 MONTH), AND LONGEST FOLLOW-UP CT SCAN AT AN AVERAGE OF 29.3 MONTHS FOR FEVAR AND 29.8 MONTHS FOR SEVAR WERE ANALYZED USING A DEDICATED 3D WORKSTATION (INTUITION, TERARECON INC, FOSTER CITY, CALIFORNIA). ABDOMINAL AORTIC ANEURYSM NECK DIAMETER WAS MEASURED IN 5 MM INCREMENTS, RANGING FROM 20 MM ABOVE TO 20 MM BELOW THE LOWEST RENAL ARTERY. SUB-ANALYSIS COMPARING THE FEVAR TO THE SEVAR GROUP AT 12 MONTHS AND AT GREATER THAN 30 MONTHS WAS PERFORMED. STANDARD STATISTICAL ANALYSIS WAS DONE. DEMOGRAPHIC CHARACTERISTICS DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO COHORTS. THE FEVAR GROUP HAD A LARGER MEAN AORTIC DIAMETER AT THE LOWEST RENAL ARTERY, SHORTER INFRARENAL AORTIC NECK LENGTH, INCREASED PREVALENCE OF NONPARALLEL NECK SHAPE, AND LONGER AAA LENGTH. ON FOLLOW-UP IMAGING, THE SUPRARENAL AORTIC SEGMENT DILATED SIGNIFICANTLY MORE AT ALL LOCATIONS IN THE FEVAR COHORT, WHEREAS THE INFRARENAL AORTIC NECK SEGMENT DILATED SIGNIFICANTLY LESS COMPARED TO THE SEVAR GROUP. COMPARED TO THE SEVAR COHORT, THE FEVAR PATIENTS DEMONSTRATED SIGNIFICANTLY GREATER POSITIVE SAC REMODELING AS EVIDENT BY MORE SAC DIAMETER REGRESSION, AND ELONGATION OF DISTANCE MEASURED FROM THE CELIAC AXIS TO THE MOST CEPHALAD MARGIN OF THE SAC. DEVICE MIGRATION, ENDOLEAK OCCURRENCE, RE-INTERVENTION RATE, AND MORTALITIES WERE SIMILAR IN BOTH GROUPS. FROM 2013 TO 2019, 76 PATIENTS WITH AAA WERE TREATED WITH FEVAR AND 213 PATIENTS WERE TREATED WITH SEVAR. INDICATIONS FOR REPAIR SUCH AS DIAMETER, GROWTH RATE >5 MM OVER 6 MONTHS, SYMPTOMATIC STATUS, AND CONCURRENT ILIAC ANEURYSM WERE BASED ON DISCRETION OF THE TREATING PHYSICIAN. INSTRUCTIONS FOR USE FROM THE MANUFACTURER WERE FOLLOWED, SPECIFICALLY WITH FEVAR USED FOR PATIENTS WITH SHORT INFRARENAL AORTIC NECK OF AT LEAST 4 MM, AND SEVAR FOR THOSE WITH NECK 15 MM OR GREATER. PARALLEL BRANCH EVAR OR PHYSICAN-MODIFIED EVAR CASES WERE EXCLUDED. ONLY PATIENTS WITH AVAILABLE PREOPERATIVE, 1-MONTH POST-OPERATIVE, AND MINIMUM 1-YEAR FOLLOW-UP COMPUTER TOMOGRAPHY ANGIOGRAM (CTA) WERE INCLUDED IN THIS STUDY. TWENTY CONSECUTIVE PATIENTS MEETING THE ABOVE INCLUSION CRITERIA TREATED USING FEVAR (ZENITH® FENESTRATED ENDOGRAFT, COOK, BLOOMINGTON, INDIANA) WERE COMPARED TO 20 CONSECUTIVE PATIENTS TREATED USING SEVAR (ZENITH® ENDOGRAFT, COOK, BLOOMINGTON, INDIANA). PRE-OPERATIVE, 1-MONTH POST-OPERATIVE, AND THE LONGEST AVAILABLE FOLLOW-UP CTA AT AN AVERAGE OF 29.3 MONTHS FOR FEVAR AND 29.8 MONTHS FOR SEVAR WERE ANALYZED USING A DEDICATED 3D WORKSTATION (INTUITION, TERARECON INC, FOSTER CITY, CALIFORNIA). BASELINE DEMOGRAPHIC AND RADIOGRAPHIC CHARACTERISTICS, PROCEDURAL DETAILS, AND CLINICAL OUTCOMES WERE ABSTRACTED AND ANALYZED. THE PRIMARY OUTCOME WAS CHANGED IN SUPRARENAL AND INFRARENAL AORTIC NECK DILATATION, AS WELL AS THE CHANGE IN THE MAXIMUM SAC DIAMETER IN THE FEVAR GROUP AND THE SEVAR GROUP OVER TIME. SECONDARY RADIOGRAPHIC OUTCOMES INCLUDED CHANGES OVER TIME IN THE DISTANCE BETWEEN CELIAC ARTERY TO THE PROXIMAL EXTENT OF THE ANEURYSM, A SURROGATE FOR SAC REMODELING, AS WELL AS CELIAC ARTERY TO THE TOP OF GRAFT FABRIC, AN ESTIMATE FOR GRAFT MIGRATION. SECONDARY CLINICAL OUTCOMES INCLUDED TYPE 2 ENDOLEAK, DEVICE-RELATED RE-INTERVENTION AND ALL-CAUSE MORTALITY. INFRARENAL AORTIC NECK LENGTH, MORPHOLOGY, DEGREE OF THROMBUS, AND CALCIFICATION WERE ASSESSED BASED ON THE PREOPERATIVE CTA. NONPARALLEL NECK SHAPE WAS DEFINED AS CHANGE IN NECK DIAMETER >10% IN PROXIMAL LANDING ZONE. SEVERE NECK THROMBUS WAS DEFINED AS CIRCUMFERENTIAL THROMBUS OR GREATEST THICKNESS OF 5 MM OR GREATER. SEVERE NECK CALCIFICATION WAS DEFINED AS CIRCUMFERENTIAL CALCIFICATION OR GREATEST THICKNESS OF 3 MM OR GREATER. MEAN DEVICE OVERSIZING WAS CALCULATED FROM (DEVICE DIAMETER ¿ AVERAGE PROXIMAL LANDING ZONE DIAMETER) AVERAGE PROXIMAL LANDING ZONE DIAMETER, USING THE PRE-OPERATIVE CTA. ALL DIAMETERS AND LENGTHS WERE PRESENTED AS PERCENT CHANGE OVER TIME; THIS WAS CALCULATED BY TAKING THE ABSOLUTE DIFFERENCE BETWEEN THE FOLLOW-UP CTA MEASUREMENT AND THE 1-MONTH (BASELINE) POST-OPERATIVE CTA MEASUREMENT, AND DIVIDING THIS BY THE 1-MONTH POST-OPERATIVE CTA MEASUREMENT. THE AVERAGE ABSOLUTE CHANGES IN DIAMETER OR DISTANCE WERE ALSO MEASURED. THE DIFFERENCE IN CATEGORICAL VARIABLES AND FREQUENCIES BETWEEN THE FEVAR AND SEVAR GROUPS WAS ANALYZED USING FISHER¿S EXACT TEST. DIFFERENCE IN CONTINUOUS VARIABLES BETWEEN THE TWO GROUPS WAS ANALYZED USING STUDENT¿S T TEST. DIFFERENCE WAS CONSIDERED AS STATISTICALLY SIGNIFICANT FOR P VALUES < 0.05 (TWO SIDED). STATISTICAL ANALYSES WERE PERFORMED BY USING SPSS SOFTWARE (VERSION 25.0, IBM CORP, ARMONK, NY). NEARLY ALL OF THE SUPRARENAL AORTIC SEGMENTS DILATED SIGNIFICANTLY MORE IN THE FEVAR GROUP COMPARED TO THE SEVAR GROUP (P < 0.05). ON THE CONTRARY, THE INFRARENAL AORTIC NECK SEGMENTS DILATED SIGNIFICANTLY LESS IN THE FEVAR GROUP COMPARED TO THE SEVAR GROUP. THE FEVAR GROUP DEMONSTRATED GREATER SAC REGRESSION AND REMODELING, AS EVIDENT BY THE DECREASE IN MAXIMUM SAC DIAMETER (-15.7% VS -4.9%, P = 0.04), AND THE INCREASE IN THE DISTANCE FROM THE CELIAC AXIS TO THE MOST CEPHALAD MARGIN OF THE SAC (29.9% VS 3.4%, P = 0.017). THE DISTANCE FROM CELIAC ARTERY TO THE TOP OF GRAFT FABRIC, A SURROGATE FOR DEVICE MIGRATION, DID NOT DIFFER BETWEEN THE TWO GROUPS. 30% OF THE SEVAR GROUP HAD TWO CONSECUTIVE SEGMENTS THAT DILATED BEYOND THE STENT GRAFT DIAMETER, WHEREAS THIS WAS FOUND IN 50% OF THE FEVAR COHORT. CLINICAL OUTCOMES SUCH AS TYPE 1A OR TYPE 2 ENDOLEAK OCCURRENCE, DEVICE-RELATED RE-INTERVENTION, AND MORTALITY WERE SIMILAR IN BOTH GROUPS, AT AN AVERAGE OF 29.3 AND 29.8 MONTHS OF FOLLOW-UP, RESPECTIVELY. THIS PR413670: DEVICE-RELATED RE-INTERVENTION RATE OF 10% IN FEVAR GROUP (N = 2). RELATED PR: PR413673: ALL CAUSE MORTALITY RATE OF 10% IN FEVAR GROUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 553427 | 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 |