Zenith Spiral-Z G55242Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10827002552422), received between Apr 2, 2015 and Feb 24, 2025 — classified as 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (10 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Fluid/Blood Leak; Obstruction of Flow; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Device Endoleak

  COOK WAS NOTIFIED OF A TYPE IB ENDOLEAK ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE DISCOVERY WAS MADE IN AN IMAGING REVIEW. THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE ON AN UNKNOWN DATE. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2024 WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS COMPLETED. THE CT SHOWED A TYPE 1A ENDOLEAK ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY. THE UNCOVERED SUPRA RENAL FIXATION HAD DETACHED FROM THE GRAFT SEALING STENT. THE GRAFT MIGRATED DISTALLY CONTRIBUTING TO THE LOSS OF THE PROXIMAL SEAL AND RESULTING IN ENLARGEMENT OF THE ANEURYSM SAC. REINTERVENTION WAS PLANNED AND THE PHYSICIAN INQUIRED ABOUT THE PLACEMENT OF A CUFF TO ADDRESS THE ENDOLEAK ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY. HOWEVER, DETAILS REGARDING THE REINTERVENTION HAVE NOT BEEN PROVIDED AT THE TIME OF THIS REPORT. IMAGING FROM THE EVENT WAS REVIEWED. THE IMAGE REVIEW IDENTIFIED A TYPE 1B ENDOLEAK ON THE RIGHT, IPSILATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT). ADDITIONALLY, MILD PARTIAL THROMBUS WAS PRESENT AT THE LIMB JUNCTIO

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 21446970 ↗
• MalfunctionSep 23, 2024Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  THE USED DELIVERY SYSTEM WAS RETURNED TO CINC FOR INVESTIGATION. THE CANNULA WAS RECEIVED BENT IN THE RETURNED PACKAGE. THE TIP OF THE SHEATH OF THE DELIVERY SYSTEM WAS OUT OF ROUND AND UNEVEN. THERE WERE NO SIGNS OF DELAMINATION/FILAMENTS. NO "SPECS" WERE IDENTIFIED IN THE TABLE TOP TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280546 ↗
• MalfunctionMay 10, 2024Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent; Device-Device Incompatibility; Difficult to Advance; Material Twisted/Bent

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, IT WAS REPORTED THAT A LUNDERQUIST WIRE WAS UNABLE TO BE PASSED THROUGH THE DEVICE. USE OF THE DEVICE WAS THEN STOPPED AND A NEW LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE ZSLE TIP WAS SLIGHTLY BENT COMING OUT OF THE PACKAGE, NO BENDS WERE FOUND ON THE WIRE. NO PATIENT CONTACT WAS MADE AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287753 ↗
• InjuryApr 5, 2024Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2024. THE PATIENT REQUIRED A DOUBLE AXILLOFEMORAL BYPASS AND THE LENGTH OF THE HOSPITALIZATION WAS VERY LONG. ADDITIONALLY, THE STAY WAS VERY COMPLICATED AFTERWARDS.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 19051635 ↗
• InjuryJun 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE BILATERAL ILIAC LIMB EXTENSION PROCEDURE HAS NOT YET BEEN PERFORMED. IT WAS NOTED THAT THE DOCTOR IS LIKELY GOING TO USE AN ILIAC BRANCH DEVICE ON THE RIGHT COMMON ILIAC. THE LEFT INTERNAL ILIAC WILL LIKELY BE COILED AND EXTENDED WITH A LIMB EXTENSION INTO THE LEFT ILIAC.

  Patient problems: Clinical Endoleak

  MAUDE report 17118928 ↗
• InjuryApr 17, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: Obstruction/Occlusion

  MAUDE report 16753154 ↗
• InjuryFeb 21, 2023Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS PROVIDED ON 26FEB2023. THE PATIENT UNDERWENT A FOLLOW UP PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE THE OCCLUSION WAS THROMBOLIZED. KISSING STENTS (BALLOON EXPANDABLE) WERE PLACED. THE FINAL IMAGING RUN WAS GOOD. HOWEVER, SOME CLOT REMAINS. IT IS UNKNOWN IF THE PATIENT HAD BEEN PRESCRIBED ANTIPLATELET OR ANTICOAGULATION THERAPY PRIOR TO THE INDEX PROCEDURE. HOWEVER, THE PATIENT WAS PRESCRIBED ANTICOAGULANT MEDICATION AFTER THE INDEX PROCEDURE AND HAD NOT CEASED THE MEDICATION PRIOR TO THE OCCLUSION.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 16409093 ↗
• InjuryOct 1, 2022Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN INDICATED THAT OVER THE PAST FEW YEARS SHE HAS HAD PATIENTS EXPERIENCE LIMB OCCLUSIONS A YEAR OR TWO AFTER IMPLANT. PATIENT SPECIFIC INFORMATION WAS PROVIDED. THE PATIENT RECEIVED THE FOLLOWING DEVICES DURING AN ENDOVASCULAR AORTIC REPAIR (EVAR) IN 2016. THE FOLLOWING COOK GRAFTS WERE IMPLANTED: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN:ZALB-28-118, LOT 6227225); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-74-ZT, LOT 6501893); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-74-ZT, LOT 5524417). THE SURGEON IDENTIFIED A LIMB OCCLUSION IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IN APRIL 2020. IT IS UNKNOWN WHICH ILIAC LEG GRAFT OCCLUDED. THE PATIENT UNDERWENT A FEMORAL TO FEMORAL CROSSOVER PROCEDURE ON (B)(6) 2020. THE PHYSICIAN INDICATED THAT THEY ARE UNWILLING TO ANSWER ANY FURTHER REQUESTS FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15524742 ↗
• InjuryFeb 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1B ENDOLEAK OCCURRED ON A RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. WHILE BALLOONING WITH A COMPETITOR'S BALLOON, IT WAS NOTED THAT THE DISTAL END OF THE RIGHT ILIAC LEG GRAFT HAD A SMALL POSSIBLE TYPE 1B ENDOLEAK. THE PHYSICIAN BALLOONED AGAIN WITH A COMPETITOR'S BALLOON, AND CAUSED A SMALL RUPTURE ON THE DISTAL EXTERNAL SIDE OF THE RIGHT ILIAC ARTERY. THERE WAS SLIGHT PLAQUE IN THE LOCATION OF BALLOONING. IT WAS NOTED THE BALLOONING CAUSED THE RUPTURE OF THE RIGHT ILIAC ARTERY. THERE WAS NO DAMAGE TO THE GRAFT OR LEAKING THROUGH THE GRAFT. THE ILIAC RUPTURE WAS REPAIRED WITH THE PLACEMENT OF AN EXTENSION GRAFT AND A COVERED STENT. THIS REPORT CAPTURES THE TYPE 1B ENDOLEAK ON THE ZENITH ILIAC LEG GRAFT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579661 ↗
• InjuryJun 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958849 ↗
• MalfunctionJun 4, 2021Complete Blockage; Complete Blockage

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11942125 ↗
• InjuryNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT DEVELOPED A TYPE 3 ENDOLEAK FOLLOWING IMPLANTATION OF TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. FOUR COOK GRAFTS INCLUDING A FENESTRATED MAIN BODY GRAFT WERE IMPLANTED ON (B)(6) 2020. APPROXIMATELY TWO MONTHS AFTER INITIAL IMPLANTATION, DURING A FOLLOW-UP VISIT, A CT SCAN REVEALED AN ENDOLEAK FROM AN UNKNOWN LOCATION WHICH WAS BELIEVED TO BE A TYPE 3. THE PATIENT WAS SCHEDULED FOR A "LIMB EXTENSION OR CUFF PROCEDURE" AS THE PHYSICIAN WAS INITIALLY UNSURE WHICH SECONDARY PROCEDURAL APPROACH WAS APPROPRIATE. SEVERAL ANGIOGRAPHIES WERE COMPLETED AND THE RIGHT LIMB WAS RELINED FROM TOP TO BOTTOM. ADDITIONALLY, TWO COMPETITOR LEG GRAFTS WERE IMPLANTED, ONE ON EACH SIDE AS THE EXACT LOCATION OF THE LEAKING WAS UNDETERMINED. A COOK BALLOON WAS USED ON BOTH SIDES AND A FINAL ANGIOGRAPHY WAS COMPLETED, SHOWING NO ENDOLEAKS PRESENT. A 30CC SYRINGE WAS USED THROUGHOUT THE PROCEDURE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. THE PATIENT OUTCOME HAS BEEN DESCRIBED AS "AS EXPECTED, GOOD AND FIXED". OTHER EVENTS REGARDING THE PATIENT'S SECONDARY PROCEDURE ARE ALSO REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Code Available

  MAUDE report 10896986 ↗
• MalfunctionFeb 7, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A (B)(6) YEAR OLD MALE PATIENT HAD A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AND MAIN BODY IMPLANTED IN (B)(6) 2017. ON (B)(6) 2020, THE DOCTOR ASKED FOR A REVIEW OF THE PATIENT'S LATEST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN, BECAUSE THERE APPEARED TO BE THROMBUS FORMATION IN THE LEFT LIMB. UPON REVIEW OF THE IMAGING, THROMBUS FORMATION IN THE LEG WAS CONFIRMED AND IT APPEARS THE THROMBUS ALSO EXTENDS INTO THE MAIN BODY. ANOTHER COMPLAINT HAS BEEN OPENED TO ADDRESS THE THROMBUS FORMATION IN THE MAIN BODY. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: Occlusion

  MAUDE report 9683782 ↗
• InjuryDec 13, 2019Partial Blockage; Complete Blockage; Fluid/Blood Leak; Partial Blockage; Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER AN ENDOVASCULAR PROCEDURE, A PATIENT HAD AN EVENT OF LEFT LEG THROMBOSIS AS WELL AS A TYPE 1B ENDOLEAK AFTER IMPLANTATION OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. ON (B)(6) 2017 (51 DAYS PRE-PROCEDURE), IMAGING SHOWED PATENT CELIAC, SUPERIOR MESENTERIC, AND RENAL ARTERIES ALONG WITH AN ANEURYSM STARTING BELOW THE RENAL ARTERIES. THE ANEURYSM HAD SEVERE ILIAC ANGULATION AND A MAXIMUM DIAMETER OF 90 MM. ON (B)(6) 2017, THE PATIENT HAD EIGHT DEVICES IMPLANTED VIA THE LEFT AND RIGHT FEMORAL ARTERIES DURING AN ENDOVASCULAR PROCEDURE, INCLUDING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. IT WAS REPORTED THAT THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICES DURING THE PROCEDURE. POST-PROCEDURE IMAGING SHOWED A TYPE II ENDOLEAK AND EVIDENCE OF DEVICE INTEGRITY ISSUES. ON (B)(6) 2017, "THE PATIENT HAD AN EVENT OF ACUTE OCCLUSION OF RIGHT POPLITEAL ARTERY", WHICH WAS TREATED BY A RIGHT THROMBECTOMY INTERVENTION. IT WAS REPORTED THAT "THIS EVENT WAS NOT RELATED TO EITHER DEVICE NOR PROCEDURE". ON (B)(6) 2017 (101 DAYS POST-PROCEDURE), ULTRASOUND IMAGING REVEALED PATENT ARTERIES AND THE TYPE II ENDOLEAK

  Patient problems: Pain; Thrombosis/Thrombus; Thrombus

  MAUDE report 9466920 ↗
• MalfunctionNov 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION REGARDING DEVICE, EVENT AND PATIENT DETAILS WAS RECEIVED ON 13NOV2019. THE SHORTENING OF THE GRAFT WAS OBSERVED WHILE THE GRAFT WAS STILL LOADED IN THE DELIVERY SYSTEM PRIOR TO DEPLOYMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE, BUT DID REQUIRE OTHER GRAFTS, THUS REDUCING THE LUMEN DIAMETER. A ZSLE-20-74-ZT AND ZISL-13-125 WERE BOTH DEPLOYED IN THE PATIENT. NO DEVICES ARE AVAILABLE FOR RETURN, AS THEY REMAIN IMPLANTED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9278586 ↗
• InjuryJul 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(4) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS PLACED ON HEPARIN FOR ANTI-COAGULATION THERAPY. A TYPE IB ENDOLEAK IN THE LEFT COMMON ILIAC WAS IDENTIFIED IN THE TIME SINCE THE INITIAL PROCEDURE. A SECOND PROCEDURE TO EXTEND THE LIMB AND SEAL OFF THE ENDOLEAK WAS COMPLETED ON (B)(4) 2019. A CODA BALLOON WAS USED IN THE OVERLAP OF THE MAIN BODY (TFFB) AND THE DISTAL EDGE ABOVE THE HYPOGASTRIC ARTERY. IT WAS FOUND THAT THE ADDITIONAL ZSLE-24-74 DID NOT SEAL ABOVE THE HYPOGASTRIC ARTERY. THE RETROGRADE FLOW HAD BEEN DELAYED, BUT WAS STILL PRESENT. THE PHYSICIAN CONSULTED WITH THE PATIENT TO GET CONSENT TO COIL THAT HYPOGASTRIC ARTERY AND EXTEND IN THE EXTERNAL ILIAC ARTERY FOR A BETTER SEAL. IT WAS LATER REPORTED THAT AN ADDITIONAL PROCEDURE TO COIL THE HYPOGASTRIC ARTERY AND EXTEND INTO THE EXTERNAL ILIAC ARTERY WAS COMPLETED SUCCESSFULLY. A GOOD SEAL WAS ACHIEVED AND THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8781481 ↗
• MalfunctionJun 12, 2019Obstruction of Flow; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Thrombus

  MAUDE report 8692272 ↗
• MalfunctionFeb 26, 2019Obstruction of Flow; Obstruction of Flow

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

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 8371467 ↗
• InjuryFeb 6, 2019Obstruction of Flow; Obstruction of Flow

  ADDITIONAL COMMENTS FROM THE PHYSICIAN. "WE DON¿T HAVE ANY CONCERNS ABOUT THE GRAFT PER SE. IT WAS REALLY ABOUT POSSIBLE THERAPEUTIC OPTIONS IN THE ACUTE SETTING. HOWEVER, THIS GENTLEMAN HAS SETTLED ON IV HEPARIN. HAEMATOLOGY GOT INVOLVED AND SUGGESTED PLAVIX AND CHANGING HIS ANTICOAGULANT. HE HAD ORIGINALLY PRESENTED WITH EMBOLISATION FROM HIS NATIVE AORTA AND REQUIRED A HALLUX AMPUTATION. WE DIDN¿T FIX HIS AORTA AT THAT TIME AS IT WAS LESS THAN 5.5 AND COMMENCED ON PLAVIX. SOME MONTHS LATER HE REPRESENTED WITH AN ISCHAEMIC 2ND TOE AND WE THEN DECIDED TO FIX HIM. HE WAS JUST ABOUT 5.5CM POST OPERATIVELY HE DEVELOPED FAST AFIB AND WAS ANTI COAGULATED AND IN FACT HIS INR WAS 3.5 AT THE TIME OF HIS PRESENTATION ON THIS ADMISSION. HIS ANTI PHOSPHOLIPID ANTIBODY WAS WEAKLY POSITIVE SO AGAIN HAEMATOLOGY ARE FOLLOWING THIS".

  Patient problems: No Code Available; Pain; Thrombus

  MAUDE report 8313130 ↗
• InjuryJan 30, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE PATIENT HAS AN OCCLUSION OF THE LEFT (IPSILATERAL) LIMB. THE PATIENT DEVELOPED LEG PAIN AND DOPPLER SHOWS AN OCCLUDED LEFT EVAR LIMB. IT WAS REPORTED THAT THEY ARE WAITING CT RESULTS AT THIS TIME. PATIENT WAS SYMPTOMATIC AND REQUIRED HOSPITAL ADMISSION. THE PATIENT PRESENTED WITH LEG PAIN ON (B)(6) 2019. NO ADDITIONAL PROCEDURES HAVE BEEN COMPLETED AT THIS TIME. THE PATIENT IS TAKING ASPIRIN AND HAD A PRE-EXISTING LARGE ILIAC ANEURYSM THAT WAS TREATED WITH A ILIAC BRANCH GRAFT.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 8289120 ↗
• InjuryNov 20, 2018Material Deformation; Material Deformation

  NO NEW EVENT INFORMATION HAS BEEN RECEIVED.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8090060 ↗
• InjuryNov 2, 2018Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Claudication; Obstruction/Occlusion; Thrombus

  MAUDE report 8034733 ↗
• InjuryDec 6, 2017Occlusion Within Device; Occlusion Within Device

  THE AREA REPRESENTATIVE REPORTED THAT A MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) AND COMMON ILIAC ARTERY (CIA) ANEURYSM HAD A STAND-ALONE COOK ILIAC SIDE BRANCH (IBD) IMPLANTED IN 2009. IT IS BELIEVED A LEFT COMMON ILIAC ARTERY (LCIA) COVERED STENT WAS ALSO IMPLANTED AND DOCTOR ASSUMES IT IS SELF-EXPANDING. IN 2013, AN AAA REPAIR WAS PERFORMED USING THE FOLLOWING COMPONENTS, A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (INTRO FROM RIGHT SIDE). A RIGHT BRIDGING LEG USING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG BRIDGING FROM THE CONTRALATERAL TROUSER LEG INTO THE IN SITU LCIA STENT. A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG ON THE LEFT SIDE EXTENDING ALL THE WAY UP TO THE CONTRALATERAL TROUSER LEG; WHICH MEANS THERE ARE THREE FABRIC LAYERS AT THIS POINT. THE PATIENT HAS FELT AN INCREASE IN BUTTOCK CLAUDICATION, AND ULTRASOUND HAS SHOWN UP TO 75% STENOSIS THROUGH THE GRAFT LIMBS. THE DOCTOR ORDERED A COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA) AND BOOKED THE PATIENT FOR SURGERY. ON (B)(6) 2017, AFTER GAINING ACCESS, THE DOCTOR USED

  Patient problems: Claudication; Stenosis

  MAUDE report 7088636 ↗
• InjuryAug 3, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT IN (B)(6) 2016, IN (B)(6), A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS USED IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. ON (B)(6) 2017, THE PATIENT WAS FLOWN TO SYDNEY FOR TREATMENT OF AN OCCLUDED LEFT LEG EXTENSION AND SUSPECTED ENDOLEAK. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS ORDERED. THE PHYSICIAN FEELS THE ENDOLEAK IS A TYPE 2 FROM THE INFERIOR MESENTERIC ARTERY, BUT THE LEFT LEG ALSO APPEARS COMPLETELY OCCLUDED. HE WILL BE ATTEMPTING A REPAIR IN THE NEXT DAY OR TWO. IT IS THE COOK REP'S UNDERSTANDING HE WILL DO A FEM/FEM CROSSOVER FOR THE OCCLUDED LEG, AND ATTEMPT TO COIL THE INFERIOR MESENTERIC ARTERY FROM THE SUPERIOR MESENTERIC ARTERY COMMUNICATION. THE COMPLAINT IS REGARDING THE LEFT LEG OCCLUSION. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE.

  Patient problems: Occlusion

  MAUDE report 6764637 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 YEARS AFTER A STANDARD ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, A CLOT WAS DISCOVERED IN THE PATIENT'S LEFT COMMON ILIAC (ZSLE-20-74-ZT). THERE IS ALSO 3 FINAL RUN PICS OF THE INITIAL EVAR PROCEDURE 2 YEARS AGO AND ONE SHOWING THE RECENT LIMB OCCLUSION, WHICH SEEMS TO OCCUR AT THE DISTAL SEALING ZONE OF THE ZSLE. THE LIMBS IN THE OCCLUSION PIC SEEMS NORMAL, NOT KINKED OR ANYTHING, AND ONCE THE CLOT WAS REMOVED, NORMAL FLOW WAS THERE AGAIN. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED THE ADDITIONAL PROCEDURES, THROMBOLOSYS AND EMBOLECTOMY. ADDITIONALLY, IT WAS REPORTED THAT THE PRODUCT CAUSED ACUTE LIMB ISCHEMIA.

  Patient problems: Thrombosis

  MAUDE report 6661198 ↗