Zenith Flex G48423Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002484235), received between Dec 12, 2014 and Nov 16, 2023 — classified as 2 deaths, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 22NOV2023. THE PHYSICIAN INDICATED THAT THEY ARE GOING TO GET A ONE MONTH SCAN BEFORE PROCEEDING WITH TREATMENT FOR THE POTENTIAL ENDOLEAK. THE PHYSICIAN INDICATED POTENTIAL ENDOLEAK MIGHT STILL BE A TYPE 2 ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149072 ↗
• DeathOct 5, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE TOP CAP INNER CANNULA OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WOULD NOT ADVANCE. DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, THE USER ATTEMPTED TO RECAPTURE THE TOP CAP AND REMOVE THE DELIVERY SYSTEM THROUGH THE IPSILATERAL LIMB; HOWEVER, THE INNER CANNULA WOULD NOT ADVANCE. IT WAS NOTED THE TRIGGER WIRE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE TOP CAP THROUGH THE GRAFT TO DOCK WITH THE BOTTOM CAP, BUT THIS WAS UNSUCCESSFUL AND THE DELIVERY SYSTEM COULD NOT BE REMOVED. AS A RESULT, THE PHYSICIAN DECIDED TO CONVERT TO OPEN SURGERY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15542653 ↗
• InjuryAug 25, 2022Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TEAR WAS DISCOVERED IN THE FABRIC OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DURING A FOLLOW UP CT FOR A 70-YEAR-OLD FEMALE PATIENT. AS A RESULT, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2022 TO COVER THE TEAR WITH AN ESBE-30-58-ZT CUFF (LOT: 10166420). NECK ANATOMY WAS DESCRIBED TO BE PARRALLEL. A 32 CODA WAS INFLATED BY HAND TO BALLOON THE PROXIMAL SEAL STENT AND OVERLAP ZONES. A CLINICAL SPECIALIST WAS PRESENT FOR THE PROCEDURE. NO PORTION OF THE PROCEDURE WAS PERFORMED OFF-LABEL AND NO ALTERATIONS WERE MADE TO THE GRAFT PRIOR TO IMPLANTATION. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298353 ↗
• InjuryApr 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1A ENDOLEAK OCCURRED 7 YEARS AFTER PLACEMENT OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DEVICE. DURING THE INDEX PROCEDURE ON (B)(6) 2013, THE PATIENT RECEIVED A ZENITH MAIN BODY AND TWO ILIAC LEG GRAFTS. ON (B)(6) 2020, A LARGE SYMPTOMATIC ANEURYSM AND TYPE 1A ENDOLEAK WAS DISCOVERED ON THE ZENITH MAIN BODY DEVICE. THE PATIENT UNDERWENT AN URGENT ENDOVASCULAR AORTIC REPAIR IN WHICH AN EXTENSION GRAFT WAS PLACED ALONG WITH A CHIMNEY STENT TO THE RIGHT RENAL ARTERY. ON (B)(6) 2021, A COMPUTED TOPOGRAPHY ANGIOGRAPHY (CTA) INDICATED A TYPE 1 ENDOLEAK AND A STENT FRACTURE ON THE EXTENSION GRAFT THAT WAS PLACED ON (B)(6) 2020. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE DUE TO THE GRAFT FRACTURE. THIS REPORT FOCUSES ON THE TYPE 1A ENDOLEAK ON THE ZENITH MAIN BODY DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Aneurysm

  MAUDE report 14002301 ↗
• InjuryNov 9, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 21FEB2022 AND 25FEB2022. IT WAS REPORTED THAT THE PATIENT WAS COMPLIANT WITH FOLLOW UP PROTOCOLS FOLLOWING PLACEMENT OF THE GRAFT IN 2013. NO ENDOLEAKS OR ANEURYSM EXPANSION WERE NOTED PRIOR TO THE DIAGNOSIS OF STENT SEPARATION. THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO PLACE A FENESTRATED GRAFT, HOWEVER THE PATIENT DIED THREE DAYS AFTER THE PROCEDURE DUE TO A HEART ATTACK. IT WAS CONFIRMED BY THE FACILITY THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. AN AUTOPSY REPORT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779368 ↗
• InjuryApr 12, 2021Difficult to Advance; Difficult to Advance

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, IT WAS CONFIRMED THAT THE STENT FROM ANOTHER MANUFACTURER WAS USED TO ADDRESS THE RUPTURE. THE ORIGINALLY INTENDED EVAR PROCEDURE WAS NOT COMPLETED AND THE CASE WAS ABORTED.

  Patient problems: Great Vessel Perforation

  MAUDE report 11649617 ↗
• DeathNov 19, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Death

  MAUDE report 10869060 ↗
• InjuryJun 13, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ON (B)(6) 2018, THE MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AS REPORTED, ON REMOVAL OF THE FIRST TRIGGER WIRE TO ALLOW THE PUSHING UP OF THE TOP CAP THERE WAS SIGNIFICANT PRESSURE NEEDED TO REMOVE IT. IT TOOK THREE HARD PULLS OF THE TRIGGER WIRE TO REMOVE T COMPLETELY. THE FORCE REQUIRED TO REMOVE IT MOVED THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY SUPRA RENAL STENT SLIGHTLY DOWNWARD INTO THE INITIAL 2MM OF FABRIC. THIS HAD NO ADVERSE EFFECT ON EITHER THE GRAFT OR ANY LEAK PROXIMALLY DURING THE FINAL ANGIOGRAPHY RUN. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7598317 ↗
• InjuryJun 30, 2017Torn Material; Torn Material

  IT WAS REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THE PHYSICIAN AND REPRESENTATIVE BELIEVE THAT THERE WAS A SUTURE HOLE IN THE FIRST SEAL STENT OF THE GRAFT. A LEAK OF CONTRAST WAS SEEN OUTSIDE OF THE GRAFT WHERE A SUTURE HOLE WOULD BE. A CUFF WAS ADDED TO COVER THE HOLE AND THE LEAK WAS NO LONGER PRESENT. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. THE PRODUCT CAUSED OR CONTRIBUTED TO THE NEED FOR AN ADDITIONAL PROCEDURE. AN ADDITIONAL CUFF WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6682293 ↗
• InjuryMay 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WAS PERFORMED WITH A ZENITH FLEX ABDOMINAL AORTIC ANEURYSM(AAA) ENDOVASCULAR MAIN BODY. ON (B)(6) 2012, THE PATIENT RECEIVED: BRANCH GRAFT: ZBIS-10-45-41 (LEFT SIDE), MAIN BODY: TFFB-30-96-ZT, ILIAC LEG (SAME SIDE): TFLE-16-56-ZT, ILIAC LEG (OPPOSITE SIDE): TFLE-14-90-ZT. JUST PRIOR TO THE INDEX PROCEDURE, THE PATIENT ALSO UNDERWENT COIL EMBOLIZATION OF THE LEFT HYPOGASTRIC ARTERY. AN AORTIC EXTENSION CUFF ESBE-30-58 WAS PLACED FOLLOWING THE STUDY PROCEDURE DUE TO A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. FOLLOW-UP IMAGING HAS BEEN REVIEWED BY CORE LAB AT 1 MONTH, 6 MONTHS, 12 MONTHS, 2 YEARS, 3 YEARS, 3.5 YEARS, 4 YEARS, 4.5 YEARS, AND 5 YEARS. THE DEVICES (MAIN BODY, ILIAC LEGS, AND BRANCH GRAFT) REMAIN INTACT AND PATENT WITH NO EVIDENCE OF KINKS. A TYPE II ENDOLEAK HAS BEEN NOTED BY THE CORE LAB AT ALL TIME POINTS THROUGH 4 YEARS. ON THE 5 YEAR COMPUTED TOMOGRAPHY (CT), THE CORE LAB IDENTIFIED A NEW PROXIMAL TYPE I ENDOLEAK. THE SITE¿S ASSESSMENT OF THE 5 YEAR CT IS NOT YET AVAILABLE. THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA HAS INCREASED SLIGHTLY FROM 67.3 MM

  Patient problems: No Code Available

  MAUDE report 6594328 ↗
• MalfunctionDec 12, 2014Activation, Positioning or Separation Problem

  AN (B)(6) YR OLD MALE PT UNDERWENT EVAR ON (B)(6) 2014. THE CONTRALATERAL GATE WAS NOT CANNULATED PRIOR TO TOP CAP DEPLOYMENT. AFTER THE PROXIMAL TRIGGER WIRE WAS REMOVED ON THE ZENITH FLEX MAIN BODY, THE DOCTOR LOOSENED THE BLACK PIN WISE AND ATTEMPTED TO DEPLOY THE SUPRARENAL TOP CAP AND MET RESISTANCE. THE SYSTEM WAS ROTATED TOGETHER. HE WAS ABLE TO PUSH IT OFF BUT IT REQUIRED EXCESSIVE FORCE. THE DEVICE LANDED A LITTLE LOW BUT THERE WAS NO NEED FOR ADDITIONAL DEVICE PLACEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4351442 ↗