Zenith Spiral-Z G55247Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002552477), received between Nov 18, 2014 and Sep 24, 2022 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2022Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  DURING IMAGING REVIEW, MURAL THROMBUS WAS DISCOVERED IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. NO ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15476260 ↗
• InjuryJun 10, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE) OCCLUDED. THE GRAFT WAS IMPLANTED IN A (B)(6) YEAR-OLD MALE PATIENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). NO KNOWN DIFFICULTIES WERE EXPERIENCED DURING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS NOT PLACED ON ANY ANTI-COAGULATION THERAPY AFTER THE INITIAL IMPLANT. ROUGHLY 1.5 YEARS AFTER IMPLANTATION, THE PATIENT PRESENTED WITH LEG PAIN AND CLAUDICATION. A CLOT INSIDE THE GRAFT LOCATED ON THE LEFT SIDE, JUST BELOW THE BIFURCATION AT THE OVERLAP SITE OF THE ZSLE AND DISTAL MAIN BODY, WAS IDENTIFIED. IT WAS ALSO NOTED THAT THE GRAFT FLOW LUMEN LOOKED "CONSTRAINED" AS IT MEASURED 7MM ON A CT SCAN AND THE GRAFT'S OUTER DIAMETER IS 12MM. AS A RESULT, A COMPETITOR DEVICE WAS PLACED TO REALIGN THE COMPLAINT DEVICE AT THE OVERLAP SITE AND TO "SMASH THE CLOT AND OPEN UP THE LIMB A BIT". THEN, THE USER "DILATED UP" WITH AN 11 AND 14 ANGIOPLASTY BALLOON. FOLLOWING THE INTERVENTION, THE PATIENT WAS PLACED ON ANTICOAGULATION THERAPY FOR SIX MONTHS. THE INTERVENTION WAS CONSIDERED SUCCESSFUL. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Ischemia; Pain; Thrombosis/Thrombus

  MAUDE report 11975118 ↗
• MalfunctionFeb 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11287901 ↗
• MalfunctionDec 11, 2020Partial Blockage; Partial Blockage

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

  Patient problems: Hyperplasia

  MAUDE report 10991798 ↗
• InjuryMay 3, 2019Obstruction of Flow; Obstruction of Flow

  IN ADDITIONAL INFORMATION RECEIVED ON 04JUN2019, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO RE-LINE THE GRAFT. AFTER SEEING THE IRREGULAR SHAPE, THE PHYSICIAN PERFORMED AN EMBOLECTOMY ON THE RIGHT SIDE AND REMOVED SOME OF THE CLOT. KISSING COVERED BALLOON EXPANDABLE STENTS (12MM X 39MM ON THE RIGHT, 12MM X 59MM ON THE LEFT) FROM ANOTHER MANUFACTURER WERE PLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available; Thrombus

  MAUDE report 8579767 ↗
• 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. 2015 FOLLOW UP WAS FINE. IT IS NOT CLEAR

  Patient problems: No Code Available

  MAUDE report 8091415 ↗
• 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 7088730 ↗
• InjuryJul 27, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PATIENT REPORTED A LIMB OCCLUSION TO HIS LEFT SIDE APPROXIMATELY 2 WEEKS POST INITIAL IMPLANTATION. THIS PATIENT HAD X 2 ZSLE'S IMPLANTED ON THE LEFT SIDE WHICH WAS VERY TORTUOUS. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE, THE PHYSICIAN PLANS IN THE FUTURE TO DO A FEM-FEM CROSSOVER GRAFT FOR THIS PATIENT DUE TO THE OCCLUSION.

  Patient problems: Occlusion

  MAUDE report 6747854 ↗
• InjuryMar 3, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED ON (B)(4) 2017 THAT THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM WITH INTRAVENOUS CATHETER FISTULA. A THREE PIECE-INFRARENAL SYSTEM (BIFURCATED GRAFT PLUS TWO LIMBS) WAS USED TO RELINE THE AORTA. UPON COMPLETION, THERE WAS A LARGE LEAK. UPON FURTHER INVESTIGATION, IT WAS DECIDED TO PUT A MAIN BODY EXTENSION INSIDE THE LOW PROFILE GRAFT TO ATTEMPT TO STOP THE LEAK; THIS WAS UNSUCCESSFUL. DESPITE A CONSIDERABLE AMOUNT OF FURTHER INVESTIGATION, IT COULD NOT BE DETERMINED WHERE THE LEAK WAS COMING FROM. THE PATIENT WAS LEFT FOR A FEW DAYS TO REIMAGE TO SEE WHETHER THE LEAK HAD RESOLVED. IT WOULD THEN BE REVIEWED BY AN INTERVENTIONAL RADIOLOGIST. A REPEAT SCAN WAS DONE ON (B)(6) 2017 OR (B)(6) 2017, AND THE IR REVIEW SUGGESTED THAT THERE MAY BE A HOLE IN THE GRAFT. AT THIS TIME, IT WAS DECIDED THAT ANOTHER DEVICE NEEDED TO BE PLANNED AND MADE URGENTLY TO RELINE THE EXISTING GRAFT. THE FOUR COMPONENTS OF THE MODULAR GRAFT SYSTEM; ZALB-26-84, ZLBE-28-45, ZSLE-24-74-ZT, AND ZSLE-24-90-ZT REMAIN IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6377713 ↗
• InjuryJan 13, 2017Leak/Splash; Leak/Splash

  ON (B)(6) 2016, AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMY WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE PHYSICIAN COIL EMBOLIZED THE RIGHT INTERNAL ILIAC ARTERY FIRST AND THEN PLACED THE BIFURCATED MAIN BODY GRAFT (1820334-2017-00013) FOLLOWED BY THE LEFT (1820334-2017-00015) AND RIGHT (1820334-2017-0016) ILIAC LEG GRAFTS AS LABELED. BALLOONING WAS ALSO PERFORMED. BY ANGIOGRAPHY FROM THE NECK SIDE, ENDOLEAK FROM THE RIGHT ABOVE THE LEFT RIM JUNCTION AND FROM BOTH LEGS WAS CONFIRMED. THE PHYSICIAN SUSPECTED IT WAS A TYPE III ENDOLEAK, SO HE PERFORMED ADDITIONAL BALLOONING AT BOTH SIDES' JUNCTION, BUT THE SITUATION WAS NOT CHANGED. THE PHYSICIAN THEN SUSPECTED A TYPE IV ENDOLEAK AND PERFORMED ANGIOGRAPHY IN THE STENT GRAFTS. THE LEAK LOOKED THE SAME AS BEFORE. HE DETERMINED IT WAS EITHER A TYPE IV OR TYPE IIIB ENDOLEAK. IT WAS DECIDED TO TAKE A WAIT-AND-SEE APPROACH BECAUSE IT WOULD BE DIFFICULT TO ADD EXTENSIONS IN EITHER TYPE OF ENDOLEAK. NEUTRALIZATION OF THE ANTI-COAGULANT ACTIVITY OF HEPARIN WAS PERFORMED BY ADMINISTRATION OF PROTAMINE AS USUAL. A WEEK AFTER THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE ENDOLEAK STILL EXISTED DURING THE FOLLOW-UP CT EXAM.

  Patient problems: No Code Available

  MAUDE report 6250627 ↗
• InjuryMay 25, 2016Kinked; Kinked

  THIS (B)(6) YR OLD MALE PATIENT IN THE (B)(6) CLINICAL STUDY WAS NOTED TO HAVE A KINK IN THE LEFT ILIAC LEG GRAFT (ON THE OPPOSITE SIDE AS THE BRANCH GRAFT) ON THE 12 MONTH FOLLOW-UP CT (365 DAYS PP). THERE WAS ALSO LOSS OF SEAL IN THE RIGHT INTERNAL ILIAC ARTERY. A SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2016 (380 DAYS PP). INDEX PROCEDURE: ON (B)(6) 2015, THE PATIENT RECEIVED THE FOLLOWING DEVICES: 12 MM X 61 MM X 58 MM BRANCH GRAFT RIGHT EIA, 24 MM X 74 MM ZENITH AAA MAIN BODY, 16 MM X 90 MM ILIAC LEG GRAFT (SAME SIDE AS BRANCH-RIGHT): 24 MM X 90 MM ILIAC LEG GRAFT (OPPOSITE SIDE BRANCH-LEFT): ANOTHER MANUFACTURER'S COVERED STENT. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY. POST STENT DILATATION WAS PERFORMED WITH A 10 MM X 20 MM BALLOON AT 10 ATM FOR 30 SECONDS. POST-PROCEDURE ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO ENDOLEAKS OR KINKS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (ONE DAY POST PROCEDURE). ONE MONTH FOLLOW-UP: ON (B)(6) 2015 (29 DAYS PP), THE ONE MONTH CT WAS PERFORMED. THE CORE LAB EVALUATION REVEALED THAT THE DEVICES WERE PATENT AND INTACT WITH NO ENDOLEAKS. A KINK WAS NOTED IN

  Patient problems: No Code Available; Thrombus

  MAUDE report 5679717 ↗
• InjuryNov 18, 2014Occlusion Within Device

  THE (B)(6) MALE PATIENT HAD ACUTE THROMBOSIS OF THE RIGHT (IPSILATERAL) LIMB OF THE STENT GRAFT WITH CONSEQUENT DEVELOPMENT OF CRITICAL LIMB ISCHEMIA. THERE WAS EVIDENCE OF EARLY STENOSIS OF THE LEFT LIMB. THERE WAS PTA AND STENTING ON THE LEFT SIDE (PATENT DONOR ILIAC) AND A SURGICAL FEM-FEM CROSS-OVER. NO ADDITIONAL INFO PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: Occlusion

  MAUDE report 4273109 ↗