Zenith Spiral-Z G55245Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002552453), received between Dec 16, 2014 and Jul 6, 2022 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.

• InjuryJul 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A STUDY PATIENT IN A CLINICAL STUDY EXPERIENCED A TYPE 1B ENDOLEAK ON THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. ON (B)(6) 2017 (160 DAYS PRE-PROCEDURE), PRE-PROCEDURE IMAGING REVEALED A STABLE TYPE IV THORACOABDOMINAL AORTIC ANEURYSM WITH MILD ILIAC ANGULATION. THE LOCATION OF START OF ANEURYSM WAS UNKNOWN. THE MAXIMUM ANEURYSM DIAMETER WAS 85.0 MM. ALL BRANCH VESSELS (CELIAC, SMA, RIGHT AND LEFT RENAL) WERE PATENT, AND THERE WERE NO RENAL INFARCTS. DURING THE INDEX PROCEDURE ON (B)(6) 2017, THE PATIENT RECEIVED 4 COOK DEVICES AND 3 COMPETITOR DEVICES, INCLUDING TWO CUSTOM MADE FENESTRATED BRANCHED DEVICES, TWO ILIAC LEG DEVICES, TWO RENAL STENTS, AND A SUPERIOR MESENTERIC ARTERY STENT. THERE WERE NO REPORTED DIFFICULTIES DEPLOYING THE DEVICES. POST-PROCEDURE IMAGING REVEALED NO EVIDENCE OF DEVICE INTEGRITY ISSUES. HOWEVER, A TYPE III ENDOLEAK AT THE JUNCTION OF THORACIC/ABDOMINAL/SMA/RIGHT RENAL STENT WAS IDENTIFIED. IMAGING WAS COMPLETED ON (B)(6) 2017, AND THE PATIENT WAS DIAGNOSED WITH A TYPE 1B ENDOLEAK ON THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE TYPE III ENDOLEAK AT THE JUN

  Patient problems: Failure of Implant

  MAUDE report 14935895 ↗
• InjuryAug 17, 2021Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 12331962 ↗
• InjuryMar 24, 2020Partial Blockage; Partial Blockage

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

  Patient problems: No Code Available; Numbness

  MAUDE report 9874062 ↗
• MalfunctionJan 23, 2020Partial Blockage; Deformation Due to Compressive Stress; Partial Blockage; Deformation Due to Compressive Stress

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

  Patient problems: Thrombus

  MAUDE report 9623429 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT A REINTERVENTION PROCEDURE WAS REQUIRED AFTER A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIGRATED AFTER IMPLANTATION DURING A FEVAR PROCEDURE. THE DEVICE AND A ZENITH FENESTRATED GRAFT WERE IMPLANTED TOGETHER IN LATE 2016. THE FENESTRATED GRAFT WAS REPORTED TO HAVE MIGRATED APPROXIMATELY 5 MM DOWNWARDS AND "HAD MIS-ALIGNED THE BRIDGING STENTS INTO THE VISCERAL VESSELS". IT WAS STATED THAT THE GRAFT WAS BELIEVED TO NOT HAVE "MIGRATED MORE THAN A COUPLE MM, BUT WE WERE PROBABLY 5MM LOW ALREADY AT THE TIME OF DEPLOYMENT". THE SURGEONS HAD TO "RE-CANNULATE EACH FENESTRATION AND RE-ALIGN USING FURTHER BRIDGING STENTS". THE REASON FOR REINTERVENTION WAS STATED AS THE "PRECARIOUS APPEARANCE OF THE VISCERAL STENTS".

  Patient problems: No Code Available

  MAUDE report 9555346 ↗
• InjuryApr 24, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT WAS USED FOR ENDOVASCULAR AORTIC REPAIR IN 2016. THE PATIENT WAS DISCHARGED HOME AFTER THE INITIAL PROCEDURE. THE PATIENT LATER DEVELOPED RIGHT LEG ISCHEMIA, DEVELOPED COMPARTMENT SYNDROME ON (B)(6) 2019, AND REQUIRED AN URGENT FEMORAL-FEMORAL CROSSOVER AND FASCIOTOMY. AS REPORTED, THE ISSUE WAS RESOLVED AFTER THE ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Ischemia; No Code Available

  MAUDE report 8547174 ↗
• InjuryApr 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION REGARDING CORRECTION OF EVENT DETAILS WAS PROVIDED. CONVERSION TO OPEN REPAIR DID NOT OCCUR. THE TYPE III ENDOLEAK ON THE LEFT SIDE (CONTRALATERAL TO THE BRANCH GRAFT) WAS TREATED WITH PERCUTANEOUS PLACEMENT OF AN ADDITIONAL LEG EXTENSION. CONSEQUENTLY, THE STUDY SITE HAS REMOVED THE CONVERSION FORM. THIS SPECIFIC PATIENT (IDENTIFIER (B)(6) IS RELATED TO REPORT REFERENCE NUMBERS 1820334-2018-00911 AND 1820334-2019-00762.

  Patient problems: Claudication; No Code Available

  MAUDE report 8484210 ↗
• InjuryApr 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THE PATIENT FROM A STUDY; IN WHICH THERE WAS LEFT COMMON ILIAC ANEURYSM GROWTH REQUIRING INTERVENTIONAL SURGERY/REMOVAL. ON (B)(6) 2014, THE PATIENT RECEIVED A BRANCH GRAFT, MAINBODY, TWO ILIAC LEG GRAFTS AND ANOTHER MANUFACTURER'S DEVICE. NO OTHER PROCEDURES WERE PERFORMED AT THE TIME OF THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. FOLLOW-UP IMAGING HAS BEEN REVIEWED BY CORE LAB AT 1 MONTH, 6 MONTHS, 12 MONTHS, AND 3 YEARS. ON (B)(6) 2014, THE PATIENT UNDERWENT THROMBOLYSIS OF THE ZBIS GRAFT DUE TO THROMBOSIS. THE DEVICES REMAIN INTACT AND PATENT WITH NO EVIDENCE OF KINKS, ENDOLEAKS, OR MIGRATION. ON THE 3-YEAR COMPUTERIZED TOMOGRAPHY (CT) SCAN, CORE LAB IDENTIFIED GROWTH OF THE RIGHT COMMON ILIAC ARTERY AND STATED THAT THE DISTAL RIGHT ILIAC LIMB GRAFT WAS NOT FULLY APPOSED TO THE WALL. PER CORE LAB: "NO STENT MIGRATION. THERE IS ANEURYSMAL DEGENERATION OF RIGHT COMMON ILIAC ARTERY." ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT EXTERNAL TO INTERNAL ILIAC ARTERY BYPASS AND PLACEMENT OF TWO OF ANOTHER MANUFACTURER'S STENTS IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON

  Patient problems: No Code Available

  MAUDE report 7400022 ↗
• InjuryApr 3, 2018Fluid/Blood Leak; Migration or Expulsion of Device; Material Twisted/Bent; Migration; Fluid/Blood Leak; Migration or Expulsion of Device; Material Twisted/Bent; Migration

  THE USER FACILITY REPORTED A (B)(6) MALE PATIENT FROM AN INVESTIGATIONAL STUDY WITH PREVIOUS HISTORY OF LARGE ABDOMINAL AORTIC ANEURYSM (AAA), ENROLLED IN THE STUDY DUE TO AAA (90 MM), AND RIGHT (54 MM) AND LEFT (56 MM) COMMON ILIAC ARTERY (CIA) ANEURYSMS ¿ WITH BRANCH GRAFT IMPLANTED ON RIGHT SIDE. THE PATIENT'S INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WAS PERFORMED ON (B)(6) 2017. AT THE TIME OF THE INDEX PROCEDURE, NO OTHER PROCEDURES WERE PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. FOLLOW-UP IMAGING HAS BEEN REVIEWED BY THE CORE LAB AT 1 MONTH, 6 MONTHS, AND 12 MONTHS. THE DEVICES REMAINED INTACT AND PATENT WITH NO EVIDENCE OF KINKS OR ENDOLEAKS. ON THE 12-MONTH FOLLOW-UP COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2018, THE CORE LAB REPORTED CRANIAL MIGRATION OF THE DISTAL LEFT ILIAC LIMB GRAFT. THE SITE DID NOT REPORT ANY MIGRATION OR PROBLEMS WITH THE OTHER IMPLANTED DEVICES. NO SECONDARY INTERVENTIONS HAVE BEEN PERFORMED.

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

  MAUDE report 7394156 ↗
• InjuryMar 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT COMMON ILIAC ANEURYSM GROWTH REQUIRING INTERVENTIONAL SURGERY/REMOVAL. ON (B)(6) 2014, THE (B)(6) MALE PATIENT WITH A HISTORY OF IMPOTENCE, GERD, AND SMOKING (PAST), UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR DUE TO AORTIC (66 MM), LEFT (29 MM) AND RIGHT (33 MM) COMMON ILIAC ARTERY ANEURYSMS. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED. POST STENT DILATATION WAS NOT PERFORMED ON THE OTHER MANUFACTURER'S STENT. PROCEDURAL ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. CORE LAB EVALUATION REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (1 DAY POST-PROCEDURE). ON (B)(6) 2018 (1173 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A SECONDARY INTERVENTION DUE TO ENLARGEMENT OF THE LEFT COMMON ILIAC ARTERY (LCIA) ANEURYSM. ANOTHER MANUFACTURER'S ENDOGRAFT WAS PLACED FROM THE LEFT COMMON ILIAC TO THE LEFT EXTERNAL ILIAC ARTERY, AND FOUR (4) COILS FROM ANOTHER MANUFACTURER WERE PLACED IN THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT HAS COMPLETED FOLLOW-UP THROUGH 3 YEARS AND REMAINS IN THE STUDY.

  Patient problems: No Code Available

  MAUDE report 7361677 ↗
• MalfunctionJul 17, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT THERE WAS LEAKAGE OF SALINE BETWEEN THE SHEATH AND THE BLACK RUBBER VALVE AND AS A RESULT, AIR COULD NOT BE REMOVED FROM THE DELIVERY SYSTEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716854 ↗
• MalfunctionDec 16, 2014Positioning Failure

  WHILE REMOVING THE DILATOR TIP PROTECTOR, IT WAS NOTICED THAT THE GRAFT WAS EXPOSED (EXPOSED AROUND 5-6MM FROM THE FLEXOR SHEATH). THE USER WAS ABLE TO ADVANCE THE SHEATH OVER THE GRAFT AND CONTINUE. HOWEVER, IT WAS NOT UNTIL THE GRAFT WAS IN VESSEL AND WHEN THEY WERE READY TO DEPLOY THE GRAFT THEY WERE UNABLE TO UNSHEATH. THE PHYSICIAN QUICKLY DECIDED NOT TO PROCEED WITH THIS ILIAC LEG GRAFT AND REMOVED IT FROM THE VESSEL. NO PART OF THE DEVICE REMAINED INSIDE THE PT. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4360369 ↗