Zenith Spiral-Z G55246Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10827002552460), received between Oct 5, 2016 and May 2, 2024 — classified as 1 death, 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  ADDITIONAL INFORMATION WAS RECEIVED ON 05JUN2024. IT WAS REPORTED THAT DUE TO THE PRONOUNCED KINKING OF THE LEFT ILIAC ARTERY WITH ASSOCIATED SHORTENING BY THE LUNDERQUIST WIRE IN PLACE, IT WAS DIFFICULT TO ESTIMATE THE DISTAL LANDING ZONE DISTANCE. FOLLOWING THE INSTRUCTIONS FOR USE (IFU), THE DELIVERY SYSTEM WAS ADVANCED AND THE LEFT ILIAC LEG WAS RELEASED TO PLACE THE DISTAL PORTION OF THE GRAFT VERY CLOSE TO THE ILIAC BIFURCATION. AN INITIAL CONTROL ANGIOGRAPHY SHOWED PARTIAL OVER-STENTING OF THE HYPOGASTRIC ARTERY TAKE-OFF. AFTER BALLOONING AND RETRACTION OF THE LUNDERQUIST WIRE WITH LENGTHENING OF THE ILIAC VESSEL, COMPLETE PATENCY OF THE HYPOGASTRIC ARTERY WAS ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234187 ↗
• InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available; Component Misassembled; Appropriate Device Problem Term/Code Not Available; Component Misassembled

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657647 ↗
• MalfunctionOct 6, 2020Difficult to Advance; Difficult to Advance

  NO NEW PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638478 ↗
• MalfunctionAug 13, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG BECAME KINKED FOLLOWING IMPLANTATION. A PRE-PROCEDURE CT PERFORMED ON (B)(6) 2017 (181 DAYS PRE-PROCEDURE) SHOWED A STABLE, JUXTARENAL AAA WITH A MAXIMUM DIAMETER OF 55 MM ALONG WITH SEVERE ILIAC ANGULATION. THE START OF THE ANEURYSM WAS BELOW THE PATIENT'S RENAL ARTERY. THE CELIAC, SMA, AND RIGHT AND LEFT RENAL ARTERIES WERE ALL PATENT WITH NO RENAL INFARCTS. ON (B)(6) 2017, THE PATIENT RECEIVED THREE COOK GRAFTS ALONG WITH FIVE COMPETITOR GRAFTS. NO DIFFICULTY WAS EXPERIENCED DEPLOYING THE DEVICES. POST-PROCEDURAL IMAGING REVEALED A TYPE II ENDOLEAK WITH NO EVIDENCE OF DEVICE INTEGRITY ISSUES. ON (B)(6) 2018 (149 DAYS POST-PROCEDURE) DURING THE PATIENT'S SIX MONTH FOLLOW-UP, AN ULTRASOUND WAS PERFORMED SHOWING PATENT CELIAC, SMA, AND RIGHT AND LEFT RENAL ARTERIES. THE TYPE II ENDOLEAK WAS STILL PRESENT. THE MAXIMUM ANEURYSM DIAMETER WAS REPORTED TO BE 49 MM. ON (B)(6) 2018 (346 DAYS POST-PROCEDURE) DURING THE PATIENT'S TWELVE MONTH FOLLOW-UP, A CT SCAN WITH CONTRAST WAS PERFORMED SHOWING NO ENDOLEAKS AND PATENT CELIAC, SMA, AND RIGHT AND LEFT RENAL ARTERIES. THE MAXIMUM ANEURYSM DIAMETER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401487 ↗
• InjuryJun 12, 2020Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  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 10148604 ↗
• InjuryFeb 7, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS FOUND TO BE OCCLUDED. THE ZENITH LEG WAS IMPLANTED IN THE LEFT ILIAC ON (B)(6) 2019. THE OCCLUSION WAS FOUND THROUGHOUT THE GRAFT AT A ROUTINE FOLLOW UP SCAN IN (B)(6) 2019. NO DIFFICULTIES WERE REPORTED DURING THE INITIAL IMPLANT. THE PATIENT WILL UNDERGO A FEM-FEM BYPASS IN MARCH TO ENSURE SUFFICIENT BLOOD FLOW TO THE LIMB. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9683603 ↗
• DeathJul 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING PATIENT, EVENT AND DEVICE DETAILS WAS RECEIVED ON (B)(6) 2019. IT IS BELIEVED THAT THE HOLE IN THE FABRIC OF THE DEVICE WASN'T CREATED BECAUSE OF A FABRIC PROBLEM, BUT RATHER FROM A BLOOD STREAM INFECTION (STAPHYLOCOCCUS AUREUS) INSTEAD. THE COURSE OF TREATMENT FOR THE INFECTION WAS IV ANTIBIOTICS. THE PATIENT WAS NOT IMMUNOSUPPRESSED. NO FURTHER IMAGING IS AVAILABLE AND NO OTHER PROCEDURES HAVE BEEN PERFORMED, AS THE PATIENT HAS DIED.

  Patient problems: Bacterial Infection; Death; No Code Available

  MAUDE report 8759581 ↗
• InjuryApr 1, 2019Obstruction of Flow; Obstruction of Flow

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT.

  Patient problems: Thrombus

  MAUDE report 8470900 ↗
• InjuryNov 20, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS INITIALLY REPORTED THE PATIENT HAD ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR OF A 13CM AAA ON (B)(6) 2014 USING TFFB MAIN BODY AND FIVE LEG EXTENSIONS. LOOKING AT THE 2018 COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA), IT APPEARS THERE IS A 13MM ZSLE SEALING INTO THE FLEX BODY ON EACH SIDE USED AS BRIDGING LIMBS. SEALING INTO THE 13MM LEG ON THE RIGHT APPEARS TO BE THE ZSLE-16, AND THE TWO ZSLE-24'S ARE BOTH ON THE LEFT SIDE WITH ONE TELESCOPING OUT THE OTHER. IT WAS REPORTED THE FOLLOWING DEVICES WERE IMPLANTED DURING THE PROCEDURE PERFORMED ON (B)(6) 2014: TFFB-24-125-ZT, ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, LOT # 4451230. ZSLE-24-90-ZT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, LOT # 4586197. ZSLE-13-74-ZT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, LOT # 4618971. ZSLE-13-90-ZT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, LOT # 4424118. ZSLE-24-74-ZT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, LOT # 4304237. ZSLE-16-90-ZT, ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, LOT # 4375912. THE 2015 FOLLOW UP WAS FINE. IT IS NOT CL

  Patient problems: No Code Available

  MAUDE report 8091413 ↗
• InjuryNov 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8034911 ↗
• InjuryJul 10, 2018Partial Blockage; Partial Blockage

  THE (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2016. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS IMPLANTED IN THE RIGHT LIMB. AS REPORTED, THE PATIENT HAS DEVELOPED PAIN AND CLAUDICATION DUE TO TOTAL RIGHT LIMB OCCLUSION. NO INTERVENTION HAS BEEN UNDERTAKEN OR IS CURRENTLY PLANNED.

  Patient problems: Claudication; Pain

  MAUDE report 7674382 ↗
• InjuryMay 31, 2018Leak/Splash; Leak/Splash

  IT WAS INITIALLY REPORTED ON (B)(6) 2017, DURING REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA), THE DOCTOR HAD DIFFICULTY IN ADVANCING THE ZALB-36-108 DEVICE UP THE RIGHT SIDE. IT WOULD NOT TRACK UP THE TORTUOUS ANATOMY. THE DECISION WAS THEN MADE TO PUT IN A BUDDY LUNDERQUIST WIRE TO HOPEFULLY STRAIGHTEN OUT THE TORTUOSITY. WHEN THE DOCTOR REMOVED THE ZALB, IT WAS NOTICED THAT THE MAIN BODY FLEXOR SHEATH WAS KINKED AND NOT INTACT. PERFORATIONS AND WIRE BRAIDING WERE VISIBLE. A 16 FRENCH INTRODUCER WAS THEN INSERTED AND A SECOND LUNDERQUIST WIRE INSERTED. THERE WAS A ZALB-36-84 (NOT THE SAME LENGTH) AVAILABLE TO USE. THIS ONE TRACKED UP NICELY WITH THE BUDDY WIRE IN SITU. THE PROCEDURE THEN PROCEEDED AS PLANNED. DUE TO THE SHORTER BODY BEING USED, A BRIDGING ZSLE-13-74-ZT WAS USED FOLLOWED BY ZSLE-20-90-ZT FOR THE CONTRALATERAL SIDE AND ZSLE-24-74-ZT FOR THE IPSILATERAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A MEDWATCH REPORT WAS NOT FILED ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY THAT WOULD NOT TRACK UP THE TORTUOUS ANATOMY AS THIS DEVICE IS NOT SOLD IN THE U.S. AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS

  Patient problems: No Code Available

  MAUDE report 7557895 ↗
• InjuryFeb 24, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A MALE PATIENT RECEIVED A FENESTRATED ENDOVASCULAR REPAIR (FEVAR) OF THE AORTA, COMMON ILIAC AND EXTERNAL ILIAC. HE HAD TO COIL THE LEFT HYPOGASTRIC ARTERY AND EXTEND A SPIRAL Z ILIAC LIMB INTO THE LEFT EXTERNAL ILIAC. THE RIGHT COMMON ILIAC WAS ALSO DISEASED BUT THE DOCTOR DIDN'T WANT TO COVER BOTH HYPOGASTRIC ARTERIES BILATERALLY. HE LANDED A 24MM ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG INTO THE DISEASED RIGHT COMMON ILIAC TO HOPEFULLY GAIN A SEAL. ON THE PATIENTS NEXT COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA) IN (B)(6) 2013, THE RIGHT COMMON ILIAC CONTINUED TO GROW AND THE LIMB NO LONGER SEALED OFF THE ANEURYSM. THE DOCTOR BROUGHT BACK THE PATIENT AND PLACED ANOTHER ZENITH ILIAC LIMB INTO THE RIGHT EXTERNAL ILIAC TO GAIN A SEAL WITH THE INITIALLY IMPLANTED RIGHT COMMON ILIAC ZENITH DEVICE REMAINING IMPLANTED. THIS REPORT INVOLVES THE SAME PATIENT WITH ISSUES PREVIOUSLY REPORTED IN MANUFACTURER REPORT #'S 9680654-2018-00005 AND 9680654-2018-00006.

  Patient problems: No Code Available

  MAUDE report 7294261 ↗
• InjuryJan 30, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED A (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2015. THE PATIENT WAS IMPLANTED WITH A Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER IN THE RIGHT ILIAC LIMB, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IN THE LEFT ILIAC LIMB. AS REPORTED ON (B)(6) 2018, THE PATIENT HAS DEVELOPED PAIN AND CLAUDICATION AND THERE IS TOTAL OCCLUSION OF ALL THREE EVAR GRAFTS. IT HAS BEEN INDICATED THAT THE PATIENT REQUIRES ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A FOLLOW-UP REQUEST HAS BEEN MADE FOR DETAILS ON ANY PLANNED OR PERFORMED SURGICAL/MEDICAL INTERVENTION. THIS EVENT INVOLVES THREE DEVICES THAT WERE REPORTED TO BE TOTALLY OCCLUDED. MFR. REPORT # 1820334-2018-00201 CAPTURES THE RIGHT ILIAC LIMB OCCLUSION AND MFR. REPORT # 1820334-2018-00202 CAPTURES THE LEFT LIMB OCCLUSION. A REPORT IS NOT BEING FILED FOR THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (CATALOG # ZALB-30-98) TOTAL OCCLUSION AS THIS DEVICE IS NOT SOLD IN THE US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE US.

  Patient problems: Claudication; Pain

  MAUDE report 7228519 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED A (B)(6), MALE ZENITH ILIAC BRANCH GRAFT SYSTEM STUDY PATIENT WAS TREATED FOR A RIGHT COMMON ILIAC ANEURYSM (CIA) AND UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2016. ACCORDING TO THE PRODUCT SPECIALIST REPORT, THE BRANCH GRAFT WAS DEPLOYED WITHOUT DIFFICULTY, BUT WHEN CONTRAST WAS INJECTED TO DEFINE THE INTERNAL ILIAC ARTERY (IIA), THE IIA WAS NOT SEEN. TWO MORE INJECTIONS WERE MADE WITH THE IMAGE INTENSIFIER AT DIFFERENT ANGLES, BUT THE IIA COULD NOT BE LOCATED IN ANY VIEW. THE DECISION WAS MADE TO OCCLUDE THE SIDE BRANCH OF THE ZBIS WITH ANOTHER MANUFACTURER'S DEVICE. THE MAIN BODY AND THE ILIAC LEGS WERE DEPLOYED WITHOUT DIFFICULTY. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY. POST-PROCEDURE ANGIOGRAPHY REVEALED NO ENDOLEAKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCANS WERE PERFORMED AT 1 MONTH AND 2 YEARS POST-PROCEDURE. ACCORDING TO THE 2-YR FOLLOW-UP CT IMAGING, THERE IS 90% STENOSIS OF THE PROXIMAL LEFT RENAL ARTERY AND 80% STENOSIS OF THE LEFT COMMON ILIAC ARTERY. THE SITE REPORTED THAT THIS WAS UNLIKELY RELATED TO THE STUDY PRODUCT AND WAS POSSIBLY RELATED

  Patient problems: No Code Available; Stenosis

  MAUDE report 7084946 ↗
• MalfunctionJul 17, 2017Material Frayed; Device Damaged Prior to Use

  IT WAS REPORTED DURING PREPARATION OF THE DEVICE, THE USER FOUND THAT THE SHEATH TIP WAS FRAYED. THIS OCCURRED PRIOR TO PATIENT CONTACT AND ANOTHER DEVICE WAS USED INSTEAD.

  Patient problems: No Patient Involvement

  MAUDE report 6716821 ↗
• InjuryDec 7, 2016Leak/Splash; Leak/Splash

  AN (B)(6) MALE PATIENT UNDERWENT A AAA REPAIR IN (B)(6) 2016. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. AFTER PLACING ALL STENT GRAFTS AS PLANNED, AN EXCESSIVE AMOUNT OF TYPE IV ENDOLEAK WAS CONFIRMED BY FINAL ANGIOGRAPHY. ANOTHER STENT GRAFT WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED AS OF THE DATE OF THIS REPORT. THE INITIAL REPORT FOR THIS EVENT WAS FILED UNDER MED-WATCH# 1820334-2016-01064, ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2016 REGARDING THE SPECIFIC DEVICES. TWO ADDITIONAL COMPLAINTS WERE OPENED TO ADDRESS THE ADDITIONAL PRODUCTS AND MED-WATCH REPORTS INITIATED UNDER: MED-WATCH# 1820334-2016-01429 FOR PART ZSLE-20-90-ZT . MED-WATCH# 1820334-2016-01430 FOR PART ZSLE-24-74-ZT (THIS REPORT)0

  Patient problems: No Code Available

  MAUDE report 6152025 ↗
• MalfunctionOct 5, 2016Material Separation; Material Separation

  A PATIENT OF UNKNOWN GENDER AND AGE UNDERWENT PLACEMENT OF AN AORTIC STENT GRAFT. THE GRAFT DEPLOYED SUCCESSFULLY. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DILATOR OUT OF THE SHEATH AND NOTICED THE VALVE WAS TIGHT. AS THE DILATOR PULLED OUT, THE VALVE POPPED OUT OF THE SHEATH. THEY HAD TO REPLACE THE SHEATH WITH ANOTHER SHEATH. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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 Known Impact Or Consequence To Patient

  MAUDE report 5999905 ↗