Zenith AlphaRecalls & reported problems across all models
William Cook Europe ApS · 67 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Zenith Alpha model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 128
- Deaths reported
- 15
- Injuries reported
- 71
- Recalls
- 1
We found 67 models of Zenith Alpha by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 128 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and Aug 7, 2026 — classified as 15 deaths, 71 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Off-Label Use” (27 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Zenith Alpha recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 18, 2025Open, Classified
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Z-0043-2026 · Root cause: Process design · names 20 of these models · Recall details · FDA record ↗
Most reported Zenith Alpha problems
Device problems
- Off-Label Use27
- Device Dislodged or Dislocated13
- Activation, Positioning or Separation Problem11
- Malposition of Device10
- Appropriate Device Problem Term/Code Not Available7
- Device Tipped Over7
- Difficult to Advance7
- Mechanical Jam7
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient18
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
- No Code Available15
- No Known Impact Or Consequence To Patient11
- Death10
- Vascular Dissection7
- Insufficient Information5
Zenith Alpha models
67 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zenith Alpha G59926SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall1 report
- Zenith Alpha G59910SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59912SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59915SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59921SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59923SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59932SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59935SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59938SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59944SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59947SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G59950SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60064SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60067SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60070SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60073SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60076SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60079SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60082SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G60084SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall0 reports
- Zenith Alpha G35359SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths14 reports
- Zenith Alpha G35375SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT8 reports
- Zenith Alpha G38190SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 deaths8 reports
- Zenith Alpha G38180SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT6 reports
- Zenith Alpha G35333SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Alpha G35335SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Alpha G35341SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Alpha G35349SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death4 reports
- Zenith Alpha G35351SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Alpha G35355SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- Zenith Alpha G35337SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 deaths3 reports
- Zenith Alpha G35357SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G35367SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G35369SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G35373SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G35395SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G38075SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G38172SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death3 reports
- Zenith Alpha G38178SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G38191SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- Zenith Alpha G35344SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G35348SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths2 reports
- Zenith Alpha G35356SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G35361SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G35391SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G35396SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G35523SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G38179SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G38204SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G38220SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- Zenith Alpha G60023SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35329SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35339SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35347SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35353SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35360SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death1 report
- Zenith Alpha G35365SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death1 report
- Zenith Alpha G35376SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35398SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35400SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35401SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35404SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G35519SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G38173SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G38203SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G38208SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- Zenith Alpha G38236SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
Recent Zenith Alpha adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Activation Problem
Description of event according to initial reporter: The bare stent did not land parallel in the aorta. They ballooned it because of the tortuosity of the stent. The patient had chest pain. There was a focal dissection in that area so there was a second stent placed successfully although there is still a small leak. Images are available.
Patient problems: Chest Pain; Vascular Dissection
MAUDE report 50172509 ↗MalfunctionJan 20, 2026No Apparent Adverse Event
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24113687 ↗MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DEPLOYED THE DEVICE WITH NO PROBLEM. WHEN REMOVING THE DELIVERY SYSTEM FORM THE SHEATH, THE PATIENT STARTED BLEEDING. IT STOPPED WHEN THE SHEATH VALVE WAS TURNED TO A CLOSED POSITION, BUT ABNORMAL AMOUNT OF BLEEDING THROUGH VALVE WHEN OPEN. PATIENT OUTCOME: THE BLOOD LOSS WAS APPROXIMAL 50ML. THE PATIENT DID NOT REQUIRE ANY TREATMENT OR BLOOD TRANSFUSION FOR THE BLOOD LOSS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21166068 ↗MalfunctionDec 4, 2024Mechanical Jam; Mechanical Jam
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ALPHA GRAFT ADVANCED INTO INTENDED POSITION WITHIN THE THORACIC AORTA. DEPLOYED PER INSTRUCTIONS FOR USE (IFU). WHEN THE PHYSICIAN STARTED TO TURN THE BLACK SAFETY, KNOB IT APPEARED TO TURN FREELY. THE BLUE ROTATION HANDLE ALSO TURNED FREELY AND THE GRAFT WAS NOT RELEASING. THE PHYSICIAN IMMEDIATELY RELEASED THE GRAFT USING THE DOCUMENTED RELEASE TROUBLESHOOTING IFU STEPS PULLED TAB, AND DISASSEMBLED THE HANDLE, WHICH RELEASED THE TRIGGER WIRES. THE DELIVERY SYSTEM WAS SAVED FOR INSPECTION. PATIENT OUTCOME: GRAFT WAS IN GOOD POSITION, AND THE AORTIC REPAIR CONTINUED. PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20841227 ↗MalfunctionOct 22, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) DESCENDING THORACIC AORTA PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38180, WAS USED. AFTER UNSHEATHING GRAFT AND DISTAL TRIGGER WIRE RELEASE FROM GRAFT, DISTAL END OF GRAFT DID NOT OPEN COMPLETELY. BALLOON WAS PLACED IN DISTAL PART OF GRAFT AND INFLATED TO OPEN GRAFT COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20503523 ↗MalfunctionSep 17, 2024Failure to Advance; Failure to Advance
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON BEGINNING A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE WE HAD DIFFICULTY TRACKING A ZTA-P-34-113-W THROUGH THE PATIENTS COMMON ILIAC. A FLEX DEVICE HAD BEEN PREVIOUSLY IMPLANTED 15 YEARS AGO, BUT IT WAS NOT BELIEVED THAT TRACKING THROUGH THE EXISTING DEVICE WAS THE ISSUE. ANGIO BALLOONS WERE UTILIZED AS WELL AS A 18FR DRY SEAL WHICH TRACKED UP POTENTIALLY DUE TO SOME MORE RIGIDITY IN THE SHEATHE. WE CONCLUDED THAT THE ALPHA ITSELF MIGHT HAVE BEEN THE ISSUE. WE DID INSPECT THE DEVICE TO CONFIRM THAT THERE WAS NO SEPARATION BETWEEN THE DILATOR AND SHEATHE AND WE DID ATTEMPT TO INSERT THE DEVICE SEVERAL TIMES UNTIL WE FELT IT WAS NECESSARY TO TRY A BACK UP DEVICE THAT WAS BROUGHT IN THE SAME SIZE. THERE WAS NO ISSUE TRACKING THE NEW DEVICE UP AND A TOTAL OF 3 DEVICES WERE IMPLANTED INTO THE PATIENT, 3 ALPHAS ( ZTA-P-34-113-W, ZTA-36-113-W, ZTA-38-167-W) AND THE INITIAL DEVICE (ZTA-P-34-113-W) WAS NOT USED. ADDITIONAL INFORMATION RECEIVED 22AUG2024: A PREVIOUS EVAR (ENDOVASCULAR AORTIC REPAIR) REPAIR WAS DONE ON THE PATIENT WITH A COOK ZENITH FLEX AAA DEVICE, NO OTHER INFORMATION WAS PROVIDED REGARDING THE SPECIFIC DEV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20234396 ↗MalfunctionJun 7, 2024Off-Label Use; Off-Label Use
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ATTACHED DEVICE WAS USED IN A CASE TODAY. HAD PATIENT CONTACT. WAS ABLE TO REMOVED IT SUCCESSFULLY AND NO HARM CAUSED TO PATIENT. THE DOCTOR WAS SPINNING THE BLUE HANDLE AND THE TRIGGER WIRES WERE DISASSOCIATED WITH THE DEVICE. WE HAD TO BREAK BACK HANDLE AND MANUALLY RELEASE THE TRIGGER WIRES. ADDITIONAL INFORMATION RECEIVED 07FEB2024: WAS THE GRAFT ALTERED IN ANY WAY PRIOR TO IMPLANT? YES ADDITIONAL INFORMATION RECEIVED 07FEB2024: IT IS NOTED THAT ¿THE DOCTOR WAS SPINNING THE BLUE HANDLE AND THE TRIGGER WIRES WERE DISASSOCIATED WITH THE DEVICE¿. DOES THIS MEAN THAT IT WAS NOT POSSIBLE TO ROTATE THE HANDLE TO STOP AND THEREFORE KEPT TURNING? CORRECT IN THE PHYSICIAN¿S OPINION, WERE THE TRIGGER WIRES DISASSOCIATED PRIOR TO SPINNING THE BLUE HANDLE OR DID IT OCCUR DURING THE ROTATION? BEFORE WAS RELEASE TROUBLESHOOTING UTILIZED AS PER THE IFU? YES WAS THE PHYSICIAN ABLE TO LAND THE DEVICE IN THE PLANNED TARGET ZONE? YES PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19482794 ↗MalfunctionApr 2, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "UPON DEPLOYMENT OF THE DEVICE, IT WAS MOVING BACKWARDS AND THEN UPON SURGEON MANIPULATING IT JUMPED FORWARD AND ENCROACHED ON THE ARCH VESSELS (INNOMINATE & LEFT COMMON CAROTID ARTERY)LCCA)). THE LEFT SUBCLAVIAN ARTERY (LSA) WAS PLANNED FOR COVERAGE AS A LCCA-LSA BYPASS WAS DONE PRIOR. UPON AN ANGIO THE LCCA HAD A FAIR AMOUNT OF COVERAGE THAT REQUIRED STENTING TO ENSURE THE VESSEL REMAINS OPEN. FINAL RESULT OF THE CASE WAS AS PLANNED WITH NO ENDOLEAK AND ALL VESSELS PRESERVED. NO PREEXISTING CONDITIONS OR COMORBIDITIES PRESENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19018944 ↗MalfunctionMar 14, 2024Mechanical Jam; Mechanical Jam
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ATTACHED GRAFT HAD ISSUES WITH DEPLOYMENT. WE MOST DEPLOYED THIS GRAFT FIRST AND THE HANDLE DID NOT CLICK WHEN TURNING (HAN SAID THE HANDLE WAS DISASSOCIATED). SO HE HAD TO POP THE BACK OF THE HANDLE OFF AND PULL THE TRIGGER WIRES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18901617 ↗InjuryFeb 2, 2024Activation Failure; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER. A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, WAS USED. WHEN THE GRAFT WAS UNSHEATHED IN THE PATIENT THE THIRD STENT FROM THE TOP WOULD NOT OPEN FULLY. IT WAS CONSTRAINED ABOUT FIFTY PERCENT. THE SURGEON USED A CODA BALLOON TO OPEN THE STENT SUCCESSFULLY. IT WAS A DISSECTION, PATIENT HAD SOME TEARS IN THEIR AORTA PATIENT OUTCOME: DISTRICT MANAGER CONTACTED THE SURGEON ONE DAY POST-OP AND SURGEON CONFIRMED THE PATIENT WAS DOING WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630473 ↗InjuryJan 30, 2024Off-Label Use; Activation Failure; Off-Label Use; Activation Failure
NO ADDITIONAL INFORMATION, REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED, SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18605230 ↗MalfunctionMar 6, 2023Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
PER THE MEDWATCH REPORT MW5117719 RECEIVED ON (B)(6) 2023: UPON INTRODUCING COOK ZENITH APHA DEVICE FOR POSITIONING AND DEPLOYMENT, THE OUTER SHEATH BROKE OFF AND SEPARATED FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16483998 ↗InjuryDec 16, 2022Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF THE DEVICE, THE PROXIMAL EDGE OF THE GRAFT WAS TIPPED SIDEWAYS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE BY REMOVING THE DELIVERY SYSTEM AND BALLOONING THE PROXIMAL EDGE OF THE GRAFT TO GET IT TO OPPOSE THE AORTIC WALL. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15996529 ↗InjuryDec 7, 2022Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF THE DEVICE, THE PROXIMAL EDGE OF THE GRAFT WAS TIPPED SIDEWAYS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE BY REMOVING THE DELIVERY SYSTEM AND BALLOONING THE PROXIMAL EDGE OF THE GRAFT TO GET IT TO OPPOSE THE AORTIC WALL. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15930105 ↗InjuryOct 14, 2022Loss of or Failure to Bond; Patient Device Interaction Problem; Loss of or Failure to Bond; Patient Device Interaction Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WITH PREVIOUS REPAIR HAD A GRAFT (UNKNOWN MANUFACTURER) 12 MONTHS AGO. AN ENDOLEAK WAS NOTED (B)(4) AND A G35391-ZTA-D-34-142-W WAS USED IN ATTEMPT TO REPAIR THE ENDOLEAK. FOUR, POSSIBLY FIVE STENTS APPEARED TO NOT OPEN. ALL BUT ONE WAS ABLE TO BE RESHEATHED; THE LAST STENT WAS ABLE TO BE REMOVED BY SLOWLY REMOVING THE WHOLE DELIVERY SYSTEM. ((B)(4)- FDA MFG REPORT# 3002808486-2022-00815) THE PROCEDURE WAS COMPLETED USING A G35351-ZTA-P-34-161-W, E4239129. INFORMATION CONCERNING THE UNKNOWN GRAFT (USED IN THE FIRST PROCEDURE, 12 MONTHS AGO): (B)(6) 2017: RIGHT TO LEFT CAROTID TO CAROTID BYPASS 7MM (DEVICE FROM ANOTHER MANUFACTURER), LEFT CAROTID TO SUBCLAVIAN ARTERY BYPASS 7MM (DEVICE FROM ANOTHER MANUFACTURER), TEVAR WITH 36-32MM AND 32MM COOK ALPHA STENT GRAFTS WITH INNOMINATE SNORKEL WITH 13MM STENT GRAFT (DEVICE FROM ANOTHER MANUFACTURER), STENT (DEVICE FROM ANOTHER MANUFACTURER) PLACEMENT IN THE DISTAL AORTIC ARCH. (B)(6) 2017: OPEN REPAIR OF AAA WITH AORTOBIILIAC GRAFT 22MM X 11MM WITH VISCERAL ARTERY DEBRANCHING WITH TWO 14MM X 7MM BIFURCATED GRAFTS OFF AORTOILIAC RECONSTRUCTION. (B)(6) 2017: REDO STENTING OF RIGHT
Patient problems: Clinical Endoleak
MAUDE report 15603169 ↗
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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