Zenith TX2 Pro-FormRecalls & reported problems across all models
William Cook Europe ApS · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 5
- Injuries reported
- 19
- Recalls
- 0
We found 15 models of Zenith TX2 Pro-Form by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2015 and Mar 21, 2022 — classified as 5 deaths, 19 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Zenith TX2 Pro-Form problems
Device problems
- Device Dislodged or Dislocated6
- Leak/Splash6
- Appropriate Device Problem Term/Code Not Available5
- Off-Label Use5
- Migration4
- Migration or Expulsion of Device4
- Difficult or Delayed Positioning2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Death4
- No Consequences Or Impact To Patient4
- Hemorrhage/Blood Loss/Bleeding3
- No Clinical Signs, Symptoms or Conditions3
- No Information3
- Paraplegia3
Zenith TX2 Pro-Form models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zenith TX2 Pro-Form G53428SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith TX2 Pro-Form G53451SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death4 reports
- Zenith TX2 Pro-Form G53432SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death3 reports
- Zenith TX2 Pro-Form G53435SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death3 reports
- Zenith TX2 Pro-Form G53450SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith TX2 Pro-Form G53431SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith TX2 Pro-Form G53447SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith TX2 Pro-Form G53452SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith TX2 Pro-Form G53480SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death2 reports
- Zenith TX2 Pro-Form G53422SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith TX2 Pro-Form G53424SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith TX2 Pro-Form G53437SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith TX2 Pro-Form G53449SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith TX2 Pro-Form G53459SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith TX2 Pro-Form G53479SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death1 report
Recent Zenith TX2 Pro-Form adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathMar 21, 2022Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6)-YEAR-OLD FEMALE WITH AN EXTENSIVE ANEURYSMAL DISEASE ALONG WITH A CHRONICALLY OCCLUDED CELIAC ARTERY AND A VERY TORTUOUS AORTA WITH A HISTORY OF FIRST STAGE ELEPHANT TRUNK REPAIR UNDERWENT A SUCCESSFUL STAGED ENDOVASCULAR TAAA REPAIR: THORACIC STENT AND ILIOFEMORAL BYPASS PLACED ON (B)(6) 2013 FOLLOWED BY CUSTOM 3-VESSEL BRANCHED STENT GRAFT AND THORACIC EXTENSION ON (B)(6) 2013. ON (B)(6) 2014, SUBJECT WAS SEEN WITH A LARGE TYPE III ENDOLEAK BETWEEN THE THORACIC EXTENSION AND THE MAIN BODY STENT GRAFTS. THIS WAS SUCCESSFULLY TREATED ON (B)(6) 2014 BY PLACING A TX2 ZTEG 36-202 AS A BRIDGE STENT GRAFT. THE SUBJECT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2014 THE ZTEG-2P-34-152-PF-US AND (B)(4) THORACO ABDOMINAL GRAFT HAD SEPARATED. BY REPORT, THE SEPARATION WAS BRIDGED WITH A ZTEG-36-202 FIVE DAYS LATER. IMPLANTATION IMAGING OR SHORT TERM FOLLOW UP WAS NOT PROVIDED. THE PATIENT REPORTEDLY PRESENTED THREE MONTHS LATER ((B)(6) 2014) WITH ABDOMINAL PAIN AND WAS FOUND TO HAVE A TYPE IIIA ENDOLEAK FROM ZTEG-36-202 AND (B)(4) THORACO ABDOMINAL GRAFT SEPARATION. THE SEPARATIONS WERE THE RESULT OF DISTAL THORACIC SUPRARENAL ABDOMINA
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13838826 ↗InjuryMar 7, 2022Off-Label Use; Off-Label Use
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER IMAGING FINDINGS UNDER (B)(4) (MANUFACTURE REF# 3002808486-2021-01887) ADDITIONAL COMPLAINT LOGGED TO COVER FOR KINK IN PROXIMAL END OF TX2: THE PHYSICIAN WAS TRYING TO DEDUCE THIS FROM THE PRE-OP IMAGING WHICH WAS DONE ON (B)(6) 2015, THE PATIENT APPEARS TO HAVE HAD A PRIOR SURGICAL ARCH RECONSTRUCTION, INCLUDING AN AORTIC VALVE REPLACEMENT. THERE HAS BEEN DEBRANCHING OF THE ARCH BRANCHES, SO THAT THEY ALL ARISE FROM A SINGLE TRUNK, THE DISTAL END OF THE SURGICAL GRAFT LOOKS TO HAVE AN ANGULATION OF ABOUT 90 DEGREES, AND INCLUDES A MARKED KINK ON THE INNER CURVE OF THAT ANGULATION. IMMEDIATELY DISTAL TO THE SURGICAL GRAFT IS A LARGE THORACOABDOMINAL ANEURYSM OF JUST OVER 60MM DIAMETER.¿ NEXT IMAGES ARE FROM (B)(6) 2016 ¿ 1 WEEK POST-PROCEDURE ¿ AND SHOW THE OVERALL SITUATION, WITH A 2-STENT OVERLAP BETWEEN THE TX2 AND THE ALPHA GRAFT IN THE DESCENDING AORTA, AND JUST OVER A 2-STENT OVERLAP BETWEEN THE ALPHA GRAFT AND THE TOP OF THE CMD. IMAGING FROM (B)(6) 2017 ¿ ABOUT 14 MONTHS POST-PROCEDURE ¿ SHOWS THE OVERLAPS ARE STILL IN PLACE, THE KINK IS STILL PRESENT IN THE TX2 GRAFT WHERE IT ¿TURNS THE CORNER¿ INTO THE PREVIOUS SURG
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13684521 ↗InjuryFeb 23, 2022Off-Label Use; Off-Label Use
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER IMAGING FINDINGS UNDER (B)(4) (MANUFACTURER REF# 3002808486-2021-01887) ADDITIONAL COMPLAINT LOGGED TO COVER FOR KINK IN PROXIMAL END OF TX2: THE PHYSICIAN WAS TRYING TO DEDUCE THIS FROM THE PRE-OP IMAGING WHICH WAS DONE ON (B)(6) 2015, THE PATIENT APPEARS TO HAVE HAD A PRIOR SURGICAL ARCH RECONSTRUCTION, INCLUDING AN AORTIC VALVE REPLACEMENT. THERE HAS BEEN DEBRANCHING OF THE ARCH BRANCHES, SO THAT THEY ALL ARISE FROM A SINGLE TRUNK, THE DISTAL END OF THE SURGICAL GRAFT LOOKS TO HAVE AN ANGULATION OF ABOUT 90 DEGREES, AND INCLUDES A MARKED KINK ON THE INNER CURVE OF THAT ANGULATION. IMMEDIATELY DISTAL TO THE SURGICAL GRAFT IS A LARGE THORACOABDOMINAL ANEURYSM OF JUST OVER 60MM DIAMETER.¿ NEXT IMAGES ARE FROM (B)(6) 2016 ¿ 1 WEEK POST-PROCEDURE ¿ AND SHOW THE OVERALL SITUATION, WITH A 2-STENT OVERLAP BETWEEN THE TX2 AND THE ALPHA GRAFT IN THE DESCENDING AORTA, AND JUST OVER A 2-STENT OVERLAP BETWEEN THE ALPHA GRAFT AND THE TOP OF THE CMD. IMAGING FROM (B)(6) 2017 ¿ ABOUT 14 MONTHS POST-PROCEDURE ¿ SHOWS THE OVERLAPS ARE STILL IN PLACE, THE KINK IS STILL PRESENT IN THE TX2 GRAFT WHERE IT ¿TURNS THE CORNER¿ INTO THE PREVIOUS SUR
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13583907 ↗InjuryJan 14, 2022Device Dislodged or Dislocated; No Apparent Adverse Event; Device Dislodged or Dislocated; No Apparent Adverse Event
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COMPONENT SEPARATION BETWEEN ZTEG 2PT 38 TO 34 (THE SECOND SPREADSHEET SAYS ¿ZTEG 2PT 38-202¿ AND MAIN BODY (34 PROXIMAL). A.(¿COMPONENT SEPARATION¿ LISTED AS DEVICE RELATED IN THE FINAL FDA REPORT). PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 13256972 ↗InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. ON (B)(6) 2016: INDEX PROCEDURE: COOK 4-VESSEL CUSTOM BRANCHED ENDOGRAFT WITH TAA PROXIMAL EXTENSION (ZTEG, ESBE AND TBE) ON (B)(6) 2020: COMPONENT SEPARATION BETWEEN THE CUSTOM ENDOGRAFT AND TAA EXTENSION -> REPAIRED WITH ALPHA ((B)(4)) ON (B)(6) 2021: PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH SYMPTOMATIC TAAA/SEPARATION OF ALPHA GRAFT FROM CUSTOM ENDOGRAFT -> DUE TO OTHER COMORBIDITIES, NO INTERVENTION WAS PERFORMED ((B)(4)).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12680727 ↗InjuryOct 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. SECONDARY PROCEDURE DONE, ALPHA 38 X 167 IMPLANTED. ON (B)(6) 2017: THORACIC ENDOGRAFT (ALPHA 38X167). RIGHT GROIN CUTDOWN. ULTRASOUND-GUIDED ACCESS OF LEFT COMMON FEMORAL ARTERY. ((B)(4)). ON (B)(6) 2018: TEVAR RE-LINING DISTAL DTA BETWEEN PREVIOUS TEVAR AND FENESTRATED ENDOGRAFTS WITH 40X150MM GORE CTAG. ((B)(4)). PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12666567 ↗InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12645648 ↗InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated
DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION BETWEEN ZTEG 2PT (42 TO 38) AND MAIN BODY (36 PROX). IMPLANT PROCEDURE DATE (B)(6) 2015. COMPONENT SEPARATION (B)(6) 2016. (B)(6) 2017: THORACIC ENDOGRAFT (ALPHA 38X167). RIGHT GROIN CUTDOWN. ULTRASOUND-GUIDED ACCESS OF LEFT COMMON FEMORAL ARTERY. (B)(4) (B)(6) 2018: TEVAR RE-LINING DISTAL DTA BETWEEN PREVIOUS TEVAR AND FENESTRATED ENDOGRAFTS WITH 40X150MM GORE CTAG. (B)(4) PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12645617 ↗MalfunctionApr 16, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
DESCRIPTION OF EVENT ACCORDING TO STUDY: GRAFT KINK. ON (B)(6) 2015, THE PATIENT RECEIVED A ZTEG-2PT-40-208-PF-US. THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS NOT USED. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE AND ANALYSIS, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (THREE DAYS POST-PROCEDURE). (B)(6) 2015 CT SCAN (40 DAYS POST-PROCEDURE): ANALYSIS: GRAFT PATENT AND INTACT WITH NO KINK OR ENDOLEAK. ANEURYSM DIAMETER = 77.7 MM. (B)(6) 2015 CT SCAN (185 DAYS POST-PROCEDURE): ANALYSIS: GRAFT PATENT AND INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. ANEURYSM DIAMETER = 67.9 MM. ANALYSIS ALSO NOTED < 1 CM DISTAL SEAL ZONE. (B)(6) 2016 CT SCAN (381 DAYS POST-PROCEDURE): CRANIAL MIGRATION AND UNKNOWN ENDOLEAK ((B)(4)). (B)(6) 2020 ANALYSIS REVIEW OF A CT PERFORMED ON (B)(6) 2019 REVEALED A PATENT AND INTACT GRAFT WITH NO ENDOLEAK PRESENT. A KINK WAS IDENTIFIED AND THE LOCATION WAS NOTED AS, ¿DISTAL AORTIC ARCH/PROXIMAL DESCENDING THORACIC AORTA.¿ ANALYSIS ALSO NOTED THE FOLLOWING, ¿AT 48 MONTHS, THERE WAS VERY EARLY NARROWING OF THE DE
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient
MAUDE report 9966547 ↗MalfunctionDec 3, 2019Fracture; Migration; Fracture; Migration
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTEG-2P-38-202-PF-US (LOT# E3187738) AND A ZTEG-2P-38-152-PF-US (LOT# E31849901). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON FROM ANOTHER MANUFACTURER WAS USED WITHOUT DIFFICULTY. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. ANALYSIS NOTED A PATENT GRAFT WITH NO KINK. A POSSIBLE ENDOLEAK WAS NOTED AT THE OVERLAP OF THE TWO DEVICES AND AT THE MID/DISTAL ASPECT OF THE DISTAL COMPONENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (FOUR DAYS POST-PROCEDURE). (B)(6) 2014 NON-CONTRAST CT SCAN (65 DAYS POST-PROCEDURE): ANALYSIS: NO KINK NOTED. ANEURYSM DIAMETER = 67.1 MM. NO OTHER ASSESSMENTS WERE MADE DUE TO NON-CONTRAST EXAM OF POOR QUALITY. (B)(6) 2015 CT SCAN (198 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO KINK. A SMALL DISTAL ENDOLEAK OF UNKNOWN ORIGIN WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 59.5 MM. (B)(6) 2015 CT SCAN (366 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO MIGRATION OR KINK. AN ENDOLEAK OF UNKNOWN TYPE WAS NOT
Patient problems: No Information
MAUDE report 9400637 ↗InjuryOct 18, 2019Migration; Migration
DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED ZTEG-2PT-36-197-PF-US (LOT # E3219029) UNDER GENERAL ANESTHESIA. A CODA-2-10.0-35-120-40 (LOT # 4931829) MOLDING BALLOON WAS USED WITHOUT DIFFICULTY OR COMPLICATION. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE IMPLANT PROCEDURE. THE PATIENT HAS BEEN FOLLOWED BY A SERIES OF CTS (DATES: (B)(6) 2014, (B)(6) 2015, (B)(6) 2017, (B)(6) 2018) WITH NO DEVICE RELATED ISSUES REPORTED. A (B)(6) 2019 CT REVEALED CAUDAD MIGRATION. CORE LAB NOTED, ¿CAUDAD (AT THE PROXIMAL END). L2 HAS INCREASED MORE THAN 10MM, AND THE 3D RECONSTRUCTIONS SHOW A CHANGE IN THE RELATIONSHIP OF THE DEVICE TO CALCIFICATION IN THE AORTIC WALL.¿ CORE LAB ALSO NOTED, ¿L2 HAS INCREASED MORE THAN 10MM, AND THE 3D RECONSTRUCTIONS SHOW A CHANGE IN THE RELATIONSHIP OF THE DEVICE TO CALCIFICATION IN THE AORTIC WALL. THE DEVICE HAS PARTIALLY OVERLAPPED THE 3RD AND 4TH STENTS OVER TIME AS ANGULATION DEVELOPED, WHICH APPEARS TO HAVE PULLED THE PROXIMAL ASPECT OF THE DEVICE IN A CAUDAD DIRECTION. L6 IS NOW ALSO >10MM INCREASED OVER THE 1 MONTH TIME POINT. IT IS NOT CLEAR THAT THIS IS DUE TO MIGRATION, AS NO DEFINITE ANATOMIC MARKERS ARE IDENTIFIED FOR
Patient problems: No Information
MAUDE report 9209153 ↗InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
PROTOCOL 08-005: PATIENT (B)(6) ¿ ENDOLEAK (TYPE UNKNOWN) ON (B)(6) 2015, THE PATIENT RECEIVED A ZTEG-2P-36-152-PF-US (LOT # E2977967). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE AND CORE LAB, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (ONE DAY POST-PROCEDURE). (B)(6) 2015 (81 DAYS POST-PROCEDURE) FOLLOW-UP CT SCAN: SITE REVIEW: PATENT, INTACT GRAFT WITH NO ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 61 MM. CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK OR ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 62.8 MM AND THE ANEURYSM LENGTH MEASURED 75.2 MM. (B)(6) 2015 (289 DAYS POST-PROCEDURE) SIX-MONTH FOLLOW-UP CT SCAN: SITE REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF MIGRATION OR ENDOLEAK. THE MAXIMUM ANEURYSM DIAMETER MEASURED 45 MM. CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK, ENDOLEAK, OR MIGRATION. THE MAXIMUM ANEURYSM DIAMETER MEASURED 51.6 MM AND THE ANEURYSM LENGTH MEASURED 69.6 MM. (B)(6) 2016 (548 DAYS POST-PROCEDURE) 12-MONTH FOLLOW-UP CT SCAN: SITE REV
Patient problems: No Code Available
MAUDE report 9209080 ↗MalfunctionOct 9, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 9171307 ↗MalfunctionOct 9, 2019Migration; Migration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Information
MAUDE report 9171303 ↗InjuryOct 9, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 9171214 ↗
Other William Cook Europe ApS products
All William Cook Europe ApS devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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