ZenithRecalls & reported problems across all models

We found 32 models of Zenith by William A. Cook Australia Pty. Ltd. in the FDA's device registry (GUDID). Together they are named in 228 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2015 and May 7, 2026 — classified as 35 deaths, 154 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (37 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 problems

Zenith models

32 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zenith G32551

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths44 reports
• Zenith G32543

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths18 reports
• Zenith G32554

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths17 reports
• Zenith G32542

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death15 reports
• Zenith G32539

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Zenith G32537

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death13 reports
• Zenith G32538

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths13 reports
• Zenith G32544

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• Zenith G32533

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death8 reports
• Zenith G32532

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• Zenith G32550

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• Zenith G32534

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Zenith G32547

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Zenith G32549

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Zenith G32561

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 reports
• Zenith G32546

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Zenith G32562

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Zenith G32548

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths4 reports
• Zenith G32592

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths4 reports
• Zenith G32536

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith G32545

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith G32500

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith G32501

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith G32535

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith G32541

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths2 reports
• Zenith G32530

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith G32531

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith G32540

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith G32563

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• Zenith G32577

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith G32578

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith G32582

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent Zenith adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Fluid/Blood Leak

  BOTH COMPONENTS WERE PLACED, THEN THERE WAS A PERSISTENT LEAK AT THE DISTAL END, THAT WOULD NOT STOP. THEY TRIED TO RE-BALLOON BUT THIS DID NOT RESOLVE THE ISSUE. THEY RESOLVED THE ISSUE BY RELINING THE FENESTRATED GRAFT USING A 28MM (ANOTHER MANUFACTURER) GRAFT INSTEAD. (ANOTHER MANUFACTURER) GRAFT PLACEMENT WAS AN ADDITIONAL PROCEDURE, AND THEY PLACED TWO ADDITIONAL LIMBS WITH THE GRAFT AS WELL.) THE PLAN FOR FOLLOW UP IS TO DO A CTA.

  Patient problems: Clinical Endoleak

  MAUDE report 25115919 ↗
• InjuryApr 24, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  BOTH COMPONENTS WERE PLACED, THEN THERE WAS A PERSISTENT LEAK AT THE DISTAL END, THAT WOULD NOT STOP. THEY TRIED TO RE-BALLOON BUT THIS DID NOT RESOLVE THE ISSUE. THEY RESOLVED THE ISSUE BY RELINING THE FENESTRATED GRAFT USING A 28MM GORE GRAFT INSTEAD. (GORE GRAFT PLACEMENT WAS AN ADDITIONAL PROCEDURE, AND THEY PLACED TWO ADDITIONAL LIMBS WITH THE GRAFT AS WELL.) THE PLAN FOR FOLLOW UP IS TO DO A CTA.

  Patient problems: Clinical Endoleak

  MAUDE report 24991104 ↗
• MalfunctionMar 15, 2026Material Twisted/Bent; Patient Device Interaction Problem

  AN 81-YEAR-OLD FEMALE PATIENT UNDERWENT A ZFEN FOR AAA PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32536, WAS USED. THE GRAFT WAS INSERTED INTO TORTUOUS ANATOMY AND WAS ROTATED (ROTATING THE GRAY POSITIONER AND SHEATH IN UNISON) TO CORRECT POSITION. THE GRAFT WAS UNSHEATHED AND CANDY-WRAPPING WAS NOTICED. THE GRAFT WAS THEN ROTATED IN THE OPPOSITE DIRECTION TO "UNWRAP". RENAL ARTERIES WERE CANNULATED AND ANSEL SHEATHS WERE ADVANCED INTO POSITION. WHEN THE GOLD TRIGGER WIRE WAS PULLED AND RELEASED, THE PHYSICIAN NOTICED SOME TENSION. THE BLACK TRIGGER WIRE WAS RELEASED AND PULLED WITH SOME TENSION AS WELL. THE PIN VISE WAS LOOSENED, THE TOP CAP WAS ADVANCED, AND THE PIN VISE TIGHTENED. THE WHITE TRIGGER WIRE WAS PULLED, AND THE WIRE BROKE OFF, FLUSH WITH THE TRIGGER MECHANISM. ADVANCED TROUBLE SHOOTING TECHNIQUES WERE FOLLOWED TO EXPOSE THE TRIGGER WIRE. THE TRIGGER WIRE WAS PULLED AND EXTREMELY TIGHT. EVENTUALLY, THE WIRE WAS REMOVED AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS TWISTED DUE TO THE TORTUOUS ILIAC OF THE PATIENT. THERE WAS SOME EVIDENCE TO SUGGEST THE GRAFT MAY HAVE BEEN TWISTED PRIOR TO INSERTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24602063 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  TYPE 3 ENDOLEAK WAS REPORTED. THE IMAGING RECEIVED CONFIRMED A TYPE 4 ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 24554822 ↗
• MalfunctionMar 8, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  ENDOLEAK BELIEVE TO BE A CROTCH TEAR. RELINED WITH A COMPETITORS GRAFT THE SAME DAY AND THE PROBLEM WAS FIXED. ADDITIONAL INFORMATION RECEIVED: THE TEAR WAS DISCOVERED DURING THE COMPLETION ANGIO. NO DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT. AFTER RELINING WITH ANOTHER GRAFT TO TRY TO ELIMINATE THE LEAK, THE PATIENT IS COMPLETELY FINE AND NO LEAK. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE ISSUE: EITHER BALLOONING THE BIFURCATION (WITH A 32 CODA - THE BALLOONING TECHNIQUE USED WAS BALLOONING EACH LEG SEPARATELY WITH THE CODA) OR A MANUFACTURING DEFECT.

  Patient problems: Clinical Endoleak

  MAUDE report 24541691 ↗
• InjuryFeb 13, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  ACCORDING TO THE INITIAL REPORTER: DURING THE ORIGINAL IMPLANT ON (B)(6) 2025, AN ENDOLEAK WAS OBSERVED, BUT ITS CAUSE HAD NOT BEEN CONFIRMED AT THE TIME. A FOLLOW-UP CT SCAN ON (B)(6) 2025, SHOWED THAT THE ANEURYSM HAD GROWN BY 0.5 CM. ANOTHER CT SCAN ON (B)(6) 2025, REVEALED AN ADDITIONAL 1.0 CM OF GROWTH. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOGRAM AND BILATERAL LIMB COMPONENT BALLOONING, BUT THE PROCEDURE DID NOT RESOLVE THE ANEURYSM, AND NO FURTHER INTERVENTIONS WERE PERFORMED AT THAT TIME. A SUBSEQUENT CT SCAN ON (B)(6) 2026, SHOWED AN ADDITIONAL 0.5 CM OF GROWTH. ON (B)(6) 2026, THE PATIENT HAD AN INTERVENTION IN WHICH A GORE EXCLUDER WAS IMPLANTED TO RESOLVE THE ISSUE. DURING THE IMPLANT PROCEDURE, THE DEVICE IFU WAS FOLLOWED, AND THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE IFU. THE ENDOLEAK WAS DISCOVERED ON THE FINAL ANGIOGRAM DURING THE DEPLOYMENT PROCEDURE. THERE WERE NO ADVERSE EVENTS, BUT THE PATIENT WAS AT RISK FOR PENDING RUPTURE. THE PATIENT OUTCOME WAS A SUCCESSFUL RE-INTERVENTION. NO PART OF THE PROCEDURE WAS PERFORMED OFF-LABEL OR OUTSIDE THE PATIENT SELECTION CRITERIA. THERE WERE NO DIFFICULTIES EXPERIENCED DURING DEPLOYMENT. THE PATIENT¿S ANAT

  Patient problems: Clinical Endoleak

  MAUDE report 24335292 ↗
• InjuryFeb 10, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  SUSPECTED FABRIC TEAR AT CROTCH OF GRAFT:DURING ORIGINAL IMPLANT ((b)(6) 2025), AN ENDOLOEAK WAS OBSERVED BUT THE CAUSE HAD NOT BEEN CONFIRMED.(b)(6) 2025 - A FOLLOW UP CT SHOWED THAT THE ANEURYSM GREW 0.5 CM.(b)(6) 2025 - AN ADDITIONAL FOLLOW UP CT SHOWED THAT THE ANEURYSM GREW AN ADDITIONAL 1.0 CM.(b)(6) 2025 - THE PATIENT WAS TAKEN IN FOR AN ANGIOGRAM AND BILATERAL LIMB COMPONENT BALLOONING. IT DID NOT RESOLVE THE ANEURYSM. THEY DID NOT DO ANYTHING ELSE.(b)(6) 2026 - ANOTHER CT SHOWED AN ADDITIONAL 0.5 CM OF GROWTH.(b)(6) 2026 - THE PATIENT HAD AN INTERVENTION THAT PUT IN A GORE EXCLUDER TO RESOLVE THE ISSUE.ADDITIONAL INFORMATION RECEIVED:DURING THE IMPLANT PROCEDURE, THE DEVICE IFU WAS FOLLOWED, AND THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE IFU. ENDOLEAK WAS DISCOVRED ON THE FINAL ANGIOGRAM DURING DEPLOYMENT PROCEDURE.THERE WERE NO ADVERSE EVENTS, BUT THE PATIENT WAS AT RISK FOR PENDING RUPTURE.THE PATIENT OUTCOME WAS SUCCESSFUL RE-INTERVENTION.NO PART OF THE PROCEDURE WAS PERFORMED OFF-LABEL OR OUT OF THE PATIENT SELECTION CRITERIA.NO DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT.THE PATIENT'S ANATOMY WAS A LITTLE TORTUOUS, BUT NOT BAD.THE PHYSICIAN THINKS A FABRIC

  Patient problems: Clinical Endoleak

  MAUDE report 24310803 ↗
• InjuryFeb 2, 2026Leak/Splash; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32543, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, G32551, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55226, AND ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55243, WERE USED. AT COMPLETION OF THE PROCEDURE THERE APPEARS TO BE NUMEROUS TYPE 3 ENDOLEAKS IN THE ZFEN-P AND THE ZSLE LIMBS. THE MEDICAL DIRECTOR PERFORMED A PRELIMINARY REVIEW OF THE IMAGING PROVIDED AND CONFIRMED THE PRESENCE OF A TYPE IIIA ENDOLEAK THAT APPEARS TO BE SMALL ENOUGH TO SETTLE SPONTANEOUSLY ONCE THE HEPARIN IS REVERSED OR WEAR OFF.

  Patient problems: Clinical Endoleak

  MAUDE report 24231087 ↗
• InjuryJan 20, 2026Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32543, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, G32551, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55226, AND ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55243, WERE USED. AT COMPLETION OF THE PROCEDURE THERE APPEARS TO BE NUMEROUS TYPE 3 ENDOLEAKS IN THE ZFEN-P AND THE ZSLE LIMBS. THE MEDICAL DIRECTOR PERFORMED A PRELIMINARY REVIEW OF THE IMAGING PROVIDED AND CONFIRMED THE PRESENCE OF A TYPE IIIA ENDOLEAK THAT APPEARS TO BE SMALL ENOUGH TO SETTLE SPONTANEOUSLY ONCE THE HEPARIN IS REVERSED OR WEAR OFF.

  Patient problems: Clinical Endoleak

  MAUDE report 24116299 ↗
• InjuryJan 20, 2026Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WHERE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32543, ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, G32551, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55226, AND ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55243, WERE USED. AT COMPLETION OF THE PROCEDURE THERE APPEARS TO BE NUMEROUS TYPE 3 ENDOLEAKS IN THE ZFEN-P AND THE ZSLE LIMBS. THE MEDICAL DIRECTOR PERFORMED A PRELIMINARY REVIEW OF THE IMAGING PROVIDED AND CONFIRMED THE PRESENCE OF A TYPE IIIA ENDOLEAK THAT APPEARS TO BE SMALL ENOUGH TO SETTLE SPONTANEOUSLY ONCE THE HEPARIN IS REVERSED OR WEAR OFF.

  Patient problems: Clinical Endoleak

  MAUDE report 24115742 ↗
• InjuryJan 9, 2026Material Integrity Problem

  A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY WAS IMPLANTED ON (B)(6) 2025. ON AN UNKNOWN DATE AN ANGIOGRAM WAS PERFORMED AND A TYPE 3 ENDOLEAK (TEAR OF FABRIC OF THE DEVICE) WAS DISCOVERED. THE TYPE 3 ENDOLEAK WAS REPORTED TO THE DISTRICT MANAGER ON (B)(6) 2025. THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Clinical Endoleak

  MAUDE report 24020890 ↗
• InjuryDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AT THE CONCLUSION OF THE IMPLANT PROCEDURE, THERE WAS A LEAK SEEN IN-BETWEEN THE TWO COMPONENTS. THE DEVICE WAS IMPLANTED; AT THE FINAL IMAGING RUN THERE WAS A BIG RUSH OF A LEAK SEEN. IT WAS THOUGHT TO BE EITHER A TYPE 3 OR A TYPE 4 ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 23933522 ↗
• InjuryDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AT THE CONCLUSION OF THE IMPLANT PROCEDURE, THERE WAS A LEAK SEEN IN-BETWEEN THE TWO COMPONENTS. THE DEVICE WAS IMPLANTED, AT THE FINAL IMAGING RUN THERE WAS A BIG RUSH OF A LEAK SEEN. IT WAS THOUGHT TO BE EITHER A TYPE 3 OR A TYPE 4 ENDOLEAK. ADDITIONAL INFORMATION RECEIVED: WHAT KIND OF ANTI-PLATELET OR ANTI-COAGULATION THERAPY WAS THE PATIENT ON? -THE PATIENT WAS FULLY HEPARINIZED DURING THE CASE. WILL THERE BE ANY ADDITIONAL PROCEDURES REQUIRED TO FIX THE REPORTED ENDOLEAK? -HE WILL GET ANOTHER SCAN IN A FEW MONTHS TO SEE IF LEAK IS STILL PRESENT. CONSIDERING A PALMAZ STENT IF LEAK IS STILL PRESENT IN FUTURE SCAN. WAS ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT? -NO DIFFICULTY DURING DEPLOYMENT. WHAT DOES THE PHYSICIAN THINK CAUSED THE ENDOLEAK? -HE THINKS THE GRAFT IS NOT FULLY APPOSED AND WAS QUESTIONING THE DIAMETERS OF DEVICE AND IF IT WAS 24 IN A 24. HE WAS CONCERNED HE WAS GIVEN A SMALLER DIAMETER. HOW MUCH OVERLAP WAS BETWEEN DISTAL AND PROXIMAL DEVICE? THE DISTAL BOFY WAS BROUGHT UP THE CROSS HAIRS -3 STENTS. WHAT IS THE CURRENT PATIENT CONDITION -PATIENT IS STABLE WITH PERSISTENT TYPE 3 LEAK. WAITING FOR RESCAN TO SEE HOW HE DOES AND IF REINTERVENTION IS NEEDED THEN.

  Patient problems: Clinical Endoleak

  MAUDE report 23861684 ↗
• InjuryDec 22, 2025Material Split, Cut or Torn; Device Endoleak; Material Split, Cut or Torn; Device Endoleak

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GRAFT IMPLANT PROCEDURE IN WHICH THE ZENITH BIFURCATED BODY GRAFT WAS USED. IT WAS STATED THERE WAS A POSSIBLE TEAR IN THE BIFURCATION OF THE DEVICE. THE FOLLOWING FURTHER INFORMATION WAS PROVIDED: THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE TO THE IFU; BALLOONING OF THE PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON. PLACEMENT OF THE DISTAL GRAFT WAS IN ACCORDANCE TO THE IFU. PLACEMENT OF A ZSLE 16 LIMB IN THE PATIENT¿S LEFT ILIAC. PLACEMENT OF A ZSLE 16 IN THE PATIENT¿S RIGHT ILIAC. BALLOONING OF BOTH THE PROXIMAL AND DISTAL BODY USING A 32 CODA BALLOON. BALLOONING OF PROXIMAL OVERLAP OF THE ZSLES WITH DISTAL BODY AND ILIACS USING A 32 CODA BALLOON. PLACEMENT OF A 26 ESBE AT PROXIMAL AND DISTAL BODY OVERLAP WHEN ENDOLEAK APPEARED ON ANGIOGRAM. RE-BALLOON OF THE PROXIMAL AND DISTAL BODY OVERLAP WHERE THE ESBE WAS PLACED.

  Patient problems: Clinical Endoleak

  MAUDE report 23861677 ↗
• InjuryDec 22, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  DURING A GRAFT IMPLANT PROCEDURE, A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATION BODY, G32551 WAS USED. IT WAS REPORTED THAT THE CASE WENT AS NORMAL. DURING ANGIOGRAM TAKEN AT THE END OF THE PROCEDURE, THE PHYSICIAN CONFIRMED THE GRAFT LOOKED GOOD IN PLACE, AND THE OVERLAP WAS GOOD. WHEN THE PHYSICIAN DID A FINAL RUN, THE PHYSICIAN FELT LIKE THERE WAS A LEAK. THE PHYSICIAN BALLOONED AGAIN AND STILL FELT THERE WAS A LEAK. THE PHYSICIAN TROUBLESHOT AND FELT THE LEAK WAS WITH THE GRAFT ITSELF. THE GRAFT REMAINS IMPLANTED; THE PHYSICIAN DID NOT REINTERVENE AND WILL DO A FOLLOW-UP IN THIRTY DAYS. FURTHER DETAILS OF THE PROCEDURE REVEALED THAT THE PROXIMAL GRAFT WAS PLACED IN ACCORDANCE WITH THE IFU; BALLOONING OF PROXIMAL GRAFT WITH A 32 CODA BALLOON, BILATERAL RENAL STENTING WITH GORE VIABAHN VBX STENTS, BALLOONING OF RENAL STENTS WITH A MUSTANG 10X2 BALLOON. PLACEMENT OF THE DISTAL GRAFT WAS IN ACCORDANCE TO IFU. PLACEMENT OF A ZSLE 13 LIMB TO EXTEND AND BRIDGE ZSLE 24 IN PATIENT¿S LEFT ILIAC. PLACEMENT OF A ZSLE 20 IN PATIENT¿S RIGHT ILIAC. BALLOONING OF BOTH PROXIMAL AND DISTAL BODY

  Patient problems: Clinical Endoleak

  MAUDE report 23861670 ↗

Other William A. Cook Australia Pty. Ltd. products

• Cook11 models · 27 reports · 1 recall