Zenith Flex G48408Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002484082), received between Jan 27, 2015 and Apr 2, 2024 — classified as 2 deaths, 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO DIFFICULTY IN ADVANCING THE DEVICE OR RESISTANCE OF ANY KIND REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 19028631 ↗
• DeathDec 6, 2023Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  ADDITIONAL INFORMATION WAS PROVIDED ON 05DEC2023. A COMPLETE MEDICAL RECORD WAS PROVIDED FOR REVIEW, THIS REPORT CONTAINS SPECIFICS RELATED TO THE PROCEDURE AND SUBSEQUENT EVENTS CONCERNING THE COOK GRAFT. PROCEDURE DATE: (B)(6) 2021. THE PATIENT WAS SEEN IN THE HOLDING ROOM. THE RISKS, BENEFITS, COMPLICATIONS, TREATMENT OPTIONS, AND EXPECTED OUTCOMES WERE DISCUSSED WITH THE PATIENT. THE POSSIBILITIES OF REACTION TO MEDICATION, PULMONARY ASPIRATION, PERFORATION OF VISCUS, BLEEDING, RECURRENT INFECTION, THE NEED FOR ADDITIONAL PROCEDURES, FAILURE TO DIAGNOSE A CONDITION, AND CREATING A COMPLICATION REQUIRING TRANSFUSION OR OPERATION WERE DISCUSSED WITH THE PATIENT. THE PATIENT CONCURRED WITH THE PROPOSED PLAN, GIVING INFORMED CONSENT. THE SITE OF SURGERY PROPERLY NOTED/MARKED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, IDENTIFIED AND THE PROCEDURE VERIFIED AS AAA REPAIR. A TIME OUT WAS HELD AND THE ABOVE INFORMATION CONFIRMED. GENERAL ENDOTRACHEAL ANESTHESIA WAS INITIATED AFTER PLACEMENT OF APPROPRIATE MONITORING LINES. AN ARTERIAL LINE WAS PLACED. ARMS WERE TUCKED AT THE SIDES. ALL PRESSURE POINTS WERE WELL PADDED. INTRAVENOUS ANTIBIOTICS WERE CONFIRMED. THE PATIENT WAS PREPARED

  Patient problems: Cardiac Arrest; Cardiomyopathy; Myocardial Infarction; Obstruction/Occlusion; Renal Failure; Thrombosis/Thrombus

  MAUDE report 18275905 ↗
• MalfunctionNov 6, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE "INNER PART OF THE SHEATH" OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY UNRAVELED. A (B)(6) MALE PATIENT WAS UNDERGOING IMPLANTATION OF THE GRAFT THROUGH THE RIGHT FEMORAL ARTERY ON (B)(6) 2020. THE GRAFT WAS FULLY DEPLOYED SUCCESSFULLY WITH BOTH TRIGGER WIRES FULLY INTACT, AS WELL AS THE TOP CAP. THE BOTTOM CAP WAS FULLY DOCKED TO THE GRAY POSITIONER. AS THE POSITIONER WAS BEING RETRACTED, IT "APPEARED TO CATCH ON THE INNER PART OF THE SHEATH", CAUSING IT TO UNRAVEL. THE DILATOR WAS ABOUT HALFWAY OUT OF THE SHEATH WHEN THERE APPEARED TO BE AN ABNORMAL AMOUNT OF PRESSURE NEEDED TO RETRACT IT. CONSEQUENTLY, THE WHOLE SHEATH WAS REMOVED AND REPLACED WITH A 18FX30 PERFORMER SHEATH. THE PATIENT HAD RELATIVELY NORMAL ANATOMY WITH SOME CALCIFICATION AT THE ACCESS SITE. NO PART OF THE PROCEDURE WAS PERFORMED OFF-LABEL OR OUT OF THE PATIENT SELECTION CRITERIA. THE GRAFT WAS NOT ALTERED IN ANY WAY PRIOR TO IMPLANTATION. THE DELIVERY SYSTEM WAS ROTATED TOGETHER AS PER THE PRODUCT IFU. THERE WAS LITTLE TO NO ROTATION NEEDED AS THE GRAFT WAS PROPERLY ORIENTED OUTSIDE THE BODY AND THE PATIENT'S ANATOMY WAS NON-TORTUOUS. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10802046 ↗
• InjuryNov 3, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BLOOD CLOTS WERE FOUND IN A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DURING A SECONDARY PROCEDURE TO TREAT THROMBUS IN A ZENITH LEG, REPORTED IN MDR# 1820334-2020-01550.

  Patient problems: No Code Available; Pain

  MAUDE report 10780435 ↗
• InjuryOct 16, 2019Material Erosion; Appropriate Device Problem Term/Code Not Available; Material Erosion; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PATIENT UNDERWENT AN EVAR ON (B)(6) 2017 AND SERIAL MONITORING OF THE SAC SHOWED IT WAS SHRINKING, UNTIL THE MOST RECENT SCAN WHICH SHOWED A SUDDEN GROWTH IN SIZE. THERE WAS "NO OBVIOUS CAUSE OF ENDOLEAK ON CTA OR ANGIOGRAM, AND A SECOND SCAN SHOWED THAT SAC WAS CONTINUING TO GROW". THE GRAFT WAS EXPLANTED ON (B)(6) 2019 AND "UPON OPENING OF THE ANEURYSMAL SAC A SMALL JET OF BLOOD WAS SEEN TO BE COMING FROM THE MAIN BODY, ABOVE THE BIFURCATION AT THE BOTTOM OF ONE OF THE EXTERNAL STENTS". THE PATIENT IS REPORTED TO BE DOING WELL POST-EXPLANT AND HAS BEEN DISCHARGED. THE EXPLANTED GRAFT WAS DISPOSED OF AND THERE IS NO IMAGING AVAILABLE FOR THIS PATIENT FOR REVIEW. THE PHYSICIAN COMMENTED THAT SHE FELT THE STENT HAD ERODED THROUGH THE GRAFT FABRIC CAUSING THE ANEURYSM SAC TO INCREASE IN SIZE.

  Patient problems: No Code Available

  MAUDE report 9197322 ↗
• InjuryOct 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  TRANSLATION OF CUSTOMER CONTACT RECORDS INDICATED NO ADDITIONAL PROCEDURES WERE PERFORMED ON THE PATIENT. THE PATIENT'S BLOOD PRESSURE AND BLOOD LIPIDS WERE CONTROLLED BY MEDICATION, AND WHILE IT WAS REPORTED " THERE IS SURGICAL TREATMENT FOR THE TIME BEING", NO DATE OR DETAILS OF AN ADDITIONAL PROCEDURE WERE PROVIDED.

  Patient problems: Abdominal Pain

  MAUDE report 9151341 ↗
• MalfunctionJul 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT COVERS THE COMPLAINT OF A TYPE 1B ENDOLEAK FOUND UPON IMAGE REVIEW FOR A RELATED COMPLAINT.

  Patient problems: No Code Available

  MAUDE report 8839181 ↗
• InjuryJun 12, 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 SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8692204 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Renal Failure

  MAUDE report 8448711 ↗
• DeathSep 21, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  THE AREA REPRESENTATIVE ADVISED THAT A PHYSICIAN REPORTED A PATIENT HAD AN UNSPECIFIED MODEL ZENITH FLEX TFFB DEVICE IMPLANTED IN 2012. ROUTINE FOLLOW-UP WITH THIS PATIENT IN 2015 FOUND NO PROBLEMS. IN (B)(6) 2017, THE PATIENT EXPERIENCED A TYPE III ENDOLEAK, AN ABDOMINAL AORTIC ANEURYSM (AAA) RUPTURE WHICH REQUIRED OPEN SURGICAL INTERVENTION. THE SURGERY WAS PERFORMED WHICH INCLUDED EXPLANTING THE ZENITH DEVICE. AS REPORTED, THE PATIENT DIED ON THE TABLE DURING THE SURGICAL PROCEDURE. THE REPORTING PHYSICIAN ADVISED THERE IS A HOLE IN THE GRAFT. NO OTHER INFORMATION WAS AVAILABLE FROM THE REPORTING PHYSICIAN. WE HAVE REACHED OUT TO THE PATIENT¿S PHYSICIAN FOR ADDITIONAL PATIENT, DEVICE AND EVENT DETAIL. ADDITIONALLY, THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN REQUESTED IN WRITING BUT HAS NOT YET BEEN PROVIDED: IMAGES FROM THE IMPLANTATION IN 2012. IMAGES FROM POST IMPLANTATION FOLLOW-UP VISITS. IMAGES PRIOR TO/DURING THE OPEN SURGICAL INTERVENTION PROCEDURE. WAS AN AUTOPSY PERFORMED? PLEASE PROVIDE A COPY OF THE AUTOPSY REPORT. WAS THE PATIENT SYMPTOMATIC IN AUGUST OF 2017, LEADING UP TO THE SURGICAL INTERVENTION? WAS THERE AN ANNUAL FOLLOW-UP PERFORMED IN 2016? IF YES, ARE WE

  Patient problems: Death; No Code Available; Rupture

  MAUDE report 6883746 ↗
• MalfunctionMar 10, 2017Leak/Splash; Leak/Splash

  (B)(6) CUSTOMER REPORTED THAT AN (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR USING ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. THE PATIENT'S ANATOMICAL FORM (STRUCTURE) WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE INFERIOR MESENTERIC ARTERY (IMA) WAS COIL EMBOLIZED PRIOR TO PLACING THE STENT GRAFTS. NO ISSUES WITH THE COILING PROCEDURE WERE REPORTED. THE ATTENDING PHYSICIAN FOLLOWED THE LABELING INSTRUCTIONS TO BALLOON THE DEVICE ONCE THE BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. A FINAL CONTRAST ANGIOGRAM WAS PERFORMED. THE PHYSICIAN CONFIRMED A "JET-LIKE" CONTRAST FROM AROUND THE FOURTH STRAT OF THE MAIN BODY GRAFT. AN ADDITIONAL ANGIOGRAM WAS CONDUCTED WITHIN THE MAIN BODY THAT CONFIRMED THE PREVIOUS "JET-LIKE" EVENT WHICH REPORTEDLY WAS INDICATIVE OF A TYPE III ENDOLEAK ORIGINATING FROM A SUTURE HOLE. THE PHYSICIAN OPTED TO DISCONTINUE BALLOONING THE GRAFT AT THE LEAK SITE TO AVOID ENLARGING THE HOLE AT THE SUTURE SITE. A "WAIT-AND-SEE" APPROACH TO THE ISSUE WAS TAKEN AND THE PROCEDURE SUBSEQUENTLY COMPLETED. THERE ARE NO REPORTED ADVERSE PATIENT EVENTS RELATED TO THE EVENT.

  Patient problems: No Code Available

  MAUDE report 6395206 ↗
• InjuryFeb 17, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  IT WAS REPORTED THAT ON (B)(6) 2014 THE PATIENT WAS TREATED FOR A 10 CM AAA AND INITIAL RESULTS WERE GREAT WITH THE AAA SHRINKING SIGNIFICANTLY ON FOLLOW UP. IN LATE (B)(6) 2016, THE PATIENT PRESENTED UNWELL AT THE HOSPITAL AND WAS HEPARINIZED AMONG OTHER TREATMENTS, FOR SUSPECTED PULMONARY EMBOLISM. AFTER A WEEK THEY HAD A CARDIAC EVENT AND CRASHED ON (B)(6) 2017. THE ON CALL VASCULAR SURGEON WAS CALLED, WHO SUSPECTED A HOLE IN THE GRAFT (JUST ABOVE THE PROXIMAL EDGE OF THE RIGHT LEG EXTENSION ON THE FABRIC GAP OF THE MAIN BODY) AND SUBSEQUENT ENDOLEAK CAUSING AAA RUPTURE. HE FEELS HE COULD TRACK THE CONTRAST FROM THE PATIENT'S RIGHT SIDE OF THE GRAFT AROUND TO THE LEFT SIDE OF THE AAA THROUGH A THIN CHANNEL, AND THAT THERE IS A RUPTURE AT THAT POINT. THE PATIENT WAS THEREFORE PREPPED FOR SURGERY WITH THE PLAN OF RELINING THEIR GRAFTS. HOWEVER, AFTER PERFORMING SEVERAL LARGE CONTRAST INJECTIONS, AND TARGETED HAND INJECTIONS OF CONTRAST HE COULD SEE NO LEAKS THROUGH THE GRAFT WHATSOEVER, AND THEREFORE NO REASON TO TREAT/RELINE. HEPARIN WAS STOPPED AFTER A NERVOUS FEW DAYS THE PATIENT HAS RECOVERED, ALTHOUGH THEY ARE STILL AN INPATIENT. THE PATIENT'S ORIGINAL SURGEON HAS NOW RETURNE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Rupture

  MAUDE report 6339434 ↗
• InjuryJul 18, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A (B)(6) MALE'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR ANEURYSM REPAIR TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PROCEDURE WAS REPORTED TO BE PERFORMED ACCORDING TO LABEL COPY. AFTER WITHDRAWAL OF THE SHEATH, A LARGE AMOUNT OF BLOOD LEAKAGE OCCURRED FROM THE HEMOSTATIC VALVE WITH THE CAPTOR VALVE CLOSED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 5801702 ↗
• InjuryDec 17, 2015Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Unintended Movement

  A AAA REPAIR WAS DONE TO TREAT INSPRA RENAL ANEURYSM ON A (B)(6) YEAR OLD MALE PATIENT. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS PLACED PER IFU. ON THE FINAL ANGIOGRAM, PARTIAL RENAL ARTERY COVERAGE WAS NOTED. AN ATTEMPT WAS MADE TO PULL THE GRAFT DOWN FURTHER DISTALLY USING A CODA BALLOON INFLATED AT THE GRAFT'S BIFURCATION. ANOTHER ANGIOGRAM WAS PERFORMED SHOWING THE GRAFT WAS MOVED FARTHER DOWN DISTALLY ABOUT 3 TO 4 MM. THE RIGHT RENAL ARTERY WAS NOW PROFUSING WELL, THE LEFT RENAL ARTERY WAS NO LONGER FILLING. THE SURGEON FELT THIS WAS DUE TO INTIMAL DISRUPTION OF THE AORTA AT THE LEVEL OF THE RENAL ORIGIN. THE SURGEON DECIDED TO SURGICALLY OPEN THE PATIENT AND RE-IMPLANT THE LEFT RENAL ARTERY TO THE AORTA. AT THE TIME OF THE REPORT, THE PATIENT WAS IN SURGERY.

  Patient problems: Insufficient Information; Intimal Dissection; No Code Available

  MAUDE report 5307531 ↗
• InjuryJan 27, 2015Leak/Splash

  THIS (B)(6) MALE PATIENT IN THE (B)(4) WAS NOTED TO HAVE AN ENDOLEAK OF UNKNOWN TYPE AT THE CONCLUSION OF THE IMPLANT PROCEDURE (PROCEDURE DATE (B)(6) 2014). THE PATIENT WAS BEING TREATED FOR 57 MM AORTIC ANEURYSM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH PARTIAL PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MODERATE TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE RIGHT ILIAC ARTERY HAD MODERATE TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE PATIENT RECEIVED A MAIN BODY DEVICE, A LEFT ILIAC LEG, AND A RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED, BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. NO ADDITIONAL DEVICES WERE USED AND NO ADDITIONAL PROCEDURES WERE PERFORMED. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS OR THROMBUS. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED.

  Patient problems: Other (for use when an appropriate patient code cannot be identified)

  MAUDE report 4476298 ↗