Zenith Spiral-Z G55226Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002552262), received between Jun 8, 2017 and Jul 3, 2024 — classified as 1 death, 5 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 23JUL2024 IN THE FORM OF OFFICIAL TRANSLATION OF PREVIOUSLY PROVIDED REPORTS. THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) ON 11MAR2013 FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE FOLLOWING COOK DEVICES WERE IMPLANTED DURING THE PROCEDURE: COOK ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-28-108). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-11-74-ZT). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-56-ZT). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-74-ZT). THE PATIENT PRESENTED TO THE EMERGENCY ROOM OF (B)(6) ON (B)(6) 2024. HE WAS CONSCIOUS AND RATED A 15 ON THE GLASCOW COMA SCALE. HE HAD A SUDDEN ONSET OF LOWER BACK PAIN THAT BEGAN ON (B)(6) 2024 AROUND 17:00 AFTER CARRYING HEAVY LOADS. HIS PAIN WAS DESCRIBED AS CRAMP-LIKE AND WAS LOCATED IN THE LEFT VERTEBRAL COLUMN. HE WAS HYPOTENSIVE AT 94/70 MMHG. AT 70 BPM HIS HEART RATE WAS NORMAL. MOTTLING WAS NOT PRESENT AND THERE WERE NO SIGNS OF DEPOSITS. THERE WAS NO INTER-ARM BLOOD PRESSURE DIFFERENT. HE WAS PANTING AT 30 BREATH

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19671216 ↗
• InjuryJan 26, 2023Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

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

  Patient problems: Clinical Endoleak

  MAUDE report 16245715 ↗
• InjuryJan 26, 2023Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

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

  Patient problems: Clinical Endoleak

  MAUDE report 16245690 ↗
• InjuryJul 11, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A TYPE IIIB ENDOLEAK WAS OBSERVED IN ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, RPN ZSLE-11-74-ZT. THE (B)(6) YEAR OLD PATIENT HAD A PRE-EXISTING (B)(6). THE PATIENT ORIGINALLY HAD THE FOLLOWING DEVICES PLACED ON (B)(6) 2019: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-82-ZT). ZENITH BRANCH ENDOVASCULAR GRAFT- ILIAC BIFURCATION (ZBIS-10-45-41). ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-39-ZT). ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-11-74-ZT). DURING THIS PROCEDURE, BALLOONING WAS COMPLETED USING A CODA BALLOON AT THE OVERLAP AND THE DISTAL END OF THE GRAFT. A 30ML SYRINGE WAS USED TO INFLATE THE BALLOON TO AN UNKNOWN VOLUME OF INFLATION. AN INSUFFLATOR WAS NOT USED FOR INFLATION. A SECONDARY INTERVENTION WAS COMPLETED ON (B)(6) 2019. ANOTHER ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-11-74-ZT) WAS IMPLANTED TO COVER THE GRAFT DEFECT.

  Patient problems: No Code Available

  MAUDE report 8781404 ↗
• InjurySep 13, 2017Occlusion Within Device; Occlusion Within Device

  THE PATIENT HAD PREVIOUSLY BEEN TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND A RIGHT INTERNAL ILIAC OCCLUSION USING A SELF OR BALLOON EXPANDABLE UNCOVERED STENT THAT EXTENDED FROM THE PATIENT¿S AORTIC BIFURCATION ALL THE WAY INTO THE EXTERNAL ILIAC . IN (B)(6) 2015, A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) WAS PERFORMED USING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE). THIS WAS PERFORMED BY A DIFFERENT PHYSICIAN AND AT ANOTHER FACILITY. THE PATIENTS RT INTERNAL ILIAC WAS ALL READY OCCLUDED PRIOR TO THIS ZFEN PROCEDURE. AS REPORTED TO COOK MEDICAL BY THE PATIENT'S NEW PHYSICIAN, THE PREVIOUSLY IMPLANTED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE) WAS THROMBOSED AND COMPLETELY OCCLUDED. THE PATIENT REQUIRED EMERGENT INTERVENTION TO TREAT CRITICAL LIMB ISCHEMIA WITH AN OCCLUDED RIGHT ILIAC LIMB. DURING THE INTERVENTION PROCEDURE, THE PREVIOUSLY IMPLANTED ZSLE WAS RE-ALIGNED WITH A LIMB FROM A DIFFERENT COMPANY. THE PHYSICIAN USED BALLOON EXPANDABLE COVERED STENTS PLACED JUST PROXIMAL TO THE FLOW DIVIDER IN THE AORTOILIAC SEGMENTS AND INFLATED TO 11 ATMOSPHERES. AS THERE WERE STILL RESIDUAL THROMBUS, A

  Patient problems: No Code Available; Thrombosis

  MAUDE report 6862615 ↗
• InjuryJun 8, 2017Leak/Splash; Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ENDOLEAK OF UNKNOWN TYPE 5 YEARS POST-IMPLANT ON (B)(6) 2012, THE PATIENT RECEIVED ONE ZTLP-PT-38-167-CI PROXIMAL COMPONENT. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICE. COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY WAS PERFORMED AFTER DEVICE DEPLOYMENT. ON THE COMPLETION ANGIOGRAM, THE CORE LAB NOTED THAT THE DEVICES WERE PATENT WITH NO KINK OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (THREE DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS ON (B)(6) 2012 (1-MONTH FOLLOW-UP, 23 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 24 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2012 (6-MONTH FOLLOW-UP, 186 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 24 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2013 (12-MONTH FOLLOW-UP, 368 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 25 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2014 (2-YEAR FOLLOW-UP, 732 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 22 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2015 (3-YEAR FOLLOW-UP, 1082 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 20 M

  Patient problems: No Code Available

  MAUDE report 6621268 ↗