Zenith Spiral-Z G55241Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002552415), received between Jan 20, 2015 and May 7, 2024 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED TO COOK INCORPORATED THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG APPEARED TOO SHORT. THE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) ON 18APR2024. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE DELIVERY SYSTEM ON THE PATIENT'S ABDOMEN TO CONFIRM LENGTH OF THE GRAFT WITH IMAGING. THE PHYSICIAN REPORTED THAT THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG APPEARED TO BE TOO SHORT. THE GRAFT WAS NOT IMPLANTED IN THE PATIENT. THE GRAFT WAS REMOVED FROM THE FIELD AND PLACED BACK IN THE PACKAGING. A ZENITH ALPHA AAA ENDOVASCULAR GRAFT ILIAC LEG (ZISL-20-59) WAS USED TO FINISH THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262238 ↗
• MalfunctionMar 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  COOK WAS NOTIFIED THAT A PATIENT PARTICIPATING IN A STUDY HAD A TYPE 1B ENDOLEAK THAT WAS PRESENT AT THE CONCLUSION OF THE PROCEDURE AND PERSISTED IN THE IMAGING COMPLETED SIX DAYS POST PROCEDURE. A PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS COMPLETED ON (B)(6) 2023 (102 DAYS PRIOR TO THE STUDY DEVICE PROCEDURE). THE INNOMINATE, RIGHT COMMON CAROTID, RIGHT SUBCLAVIAN, LEFT COMMON CAROTID, LEFT SUBCLAVIAN, AND THE CELIAC ARTERIES WERE INCORPORATED IN THE REPAIR. THE ARTERIES WERE PATENT AND NO VESSEL STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE RIGHT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE LEFT RENAL ARTERY WAS INCORPORATED IN THE REPAIR. THE ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS PRESENT. THE LEFT AND RIGHT COMMON ILIAC ARTERIES WERE PATENT. THE LEFT AND RIGHT INTERNAL ILIAC ARTERIES WERE PATENT. THE AORTIC VALVE WAS NATIVE. THE METHOD OF LENGTH MEASUREMENT WAS CENTERLINE. THE LENGTH FROM THE SINOTUBULAR JUNCTION, OR PROXIMAL SUTURE IF ASCEND

  Patient problems: Clinical Endoleak

  MAUDE report 18942739 ↗
• InjuryOct 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COOK THAT A PROVIDER SUSPECTED A TYPE 3B ENDOLEAK AT THE CONCLUSION OF A PROCEDURE WHERE A COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED. THE PATIENT HAD BEEN DIAGNOSED WITH AN AORTIC ANEURYSM AND ATRIAL FIBRILLATION (RECENT DIAGNOSIS, DATE UNKNOWN). ON (B)(6) 2023 HE UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WHERE THE FOLLOWING COOK DEVICES WERE IMPLANTED: COOK CUSTOM MADE FENESTRATED GRAFT, (RPN: AAA-REINFORCED-FEN-PROX, LOT NUMBER AC1125954). COOK CUSTOM MADE BIFURCATED MAIN BODY GRAFT (RPN: AAA-BIFURCATED-GRAFT, LOT NUMBER AC1125955). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 14220387). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 14154411). ALL GRAFTS WERE IMPLANTED WITH TECHNICAL SUCCESS. HOWEVER, ON THE FINAL RUN, THERE WAS AN ENDOLEAK NOTED. THE SOURCE OF THE ENDOLEAK WAS UNCLEAR AND COULD NOT BE DETERMINE OR CLASSIFIED BY ANY PARTY ON THE DAY OF THE PROCEDURE. MULTIPLE ANGIOGRAPHY RUNS WERE COMPLETED AT THE PROXIMAL END AROUND THE VISCERAL VESSELS AND ALSO IN EACH LIMB. NO

  Patient problems: Clinical Endoleak

  MAUDE report 17945034 ↗
• InjuryOct 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO COOK THAT A PROVIDER SUSPECTED A TYPE 3B ENDOLEAK AT THE CONCLUSION OF A PROCEDURE WHERE A COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED. THE PATIENT HAD BEEN DIAGNOSED WITH AN AORTIC ANEURYSM AND ATRIAL FIBRILLATION (RECENT DIAGNOSIS, DATE UNKNOWN). ON (B)(6) 2023 HE UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WHERE THE FOLLOWING COOK DEVICES WERE IMPLANTED: COOK CUSTOM MADE FENESTRATED GRAFT, (RPN: AAA-REINFORCED-FEN-PROX, LOT NUMBER AC1125954). COOK CUSTOM MADE BIFURCATED MAIN BODY GRAFT (RPN: AAA-BIFURCATED-GRAFT, LOT NUMBER AC1125955). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 14220387). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 14154411). ALL GRAFTS WERE IMPLANTED WITH TECHNICAL SUCCESS. HOWEVER, ON THE FINAL RUN, THERE WAS AN ENDOLEAK NOTED. THE SOURCE OF THE ENDOLEAK WAS UNCLEAR AND COULD NOT BE DETERMINE OR CLASSIFIED BY ANY PARTY ON THE DAY OF THE PROCEDURE. MULTIPLE ANGIOGRAPHY RUNS WERE COMPLETED AT THE PROXIMAL END AROUND THE VISCERAL VESSELS AND ALSO IN EACH LIMB. NO

  Patient problems: Clinical Endoleak

  MAUDE report 17944298 ↗
• MalfunctionOct 5, 2023Fluid/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: Clinical Endoleak

  MAUDE report 17876289 ↗
• MalfunctionJun 29, 2023Difficult to Advance; Difficult to Advance

  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 17229461 ↗
• InjuryMay 15, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 16930972 ↗
• InjuryApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1B ENDOLEAK WAS IDENTIFIED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING THE INVESTIGATION IMAGE REVIEW FOR A SUPRARENAL STENT SEPARATION FROM THE MAIN BODY GRAFT. THE INDEX PROCEDURE OCCURRED IN (B)(6) 2012, IN WHICH THE FOLLOWING COOK GRAFTS WERE IMPLANTED: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-26-118, LOT 3850195); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT: 3726317), LEFT, CONTRALATERAL; ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZALL-18-36, LOT: 3413921) RIGHT, IPSILATERAL. THE ANEURYSM SAC MEASURED THE SAME SIZE IN OCTOBER 2014 AS IT DID ON THE DATE OF IMPLANT. BY NOVEMBER 2016, THE ANEURYSM SAC HAD GROWN 1.4 CM. TEN YEARS POST-OP, THE SUPRARENAL STENT OF THE MAIN BODY GRAFT WAS FOUND TO BE SEPARATED, AND THE PATIENT REQUIRED A CUSTOM-MADE DEVICE (CMD) TO REPAIR THE ENDOLEAK CAUSED BY THE GRAFT SEPARATION. UPON REVIEW OF THE IMAGING DURING THE GRAFT SEPARATION INVESTIGATION, TYPE 1B ENDOLEAKS WERE FOUND ON BOTH ILIAC LEGS. THE TYPE 1B ENDOLEAKS WERE TREATED WITH ZBIS DEVICES. THE PATIENT WAS REPORTED TO BE COMPLIANT WITH F

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16677523 ↗
• InjuryJan 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A TYPE 1B ENDOLEAK ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DISCOVERED IN IMAGING REVIEW. THE PATIENT HAD AN ABDOMINAL AORTIC ANEURYSM (AAA) AND ENDOVASCULAR AORTIC REPAIR (EVAR) WAS COMPLETED ON (B)(6) 2014. DURING THE EVAR, THE PATIENT HAD SEVERAL COOK GRAFTS PLACED: ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (RPN: ZALB-30-28; LOT NUMBER 4143550), ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-13-74-ZT; LOT NUMBER 9394305) PLACED ON THE RIGHT (IPSILATERAL) SIDE, AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT; LOT#: 2808514) PLACED ON THE LEFT (CONTRALATERAL) SIDE. IMAGING WAS COMPLETED ON (B)(6) 2020 AND A TYPE 1B ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT; LOT#: 2808514) PLACED ON THE LEFT (CONTRALATERAL) SIDE WAS IDENTIFIED. AN EVAR REPAIR TO TREAT A RUPTURED ANEURYSM WAS COMPLETE COMPLETED ON (B)(6) 2020. DURING THE EVAR REPAIR TO TREAT THE RUPTURED ANEURYSM, THE FOLLOWING COOK DEVICES WERE PLACED: ZENITH ALPHA SPIRAL-Z ENDOVASCULAR LEG (RPN: ZISL-13-110, LOT 9566245), ZENITH ALPHA SPIRA

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 16109046 ↗
• InjuryAug 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1B DISTAL ENDOLEAK OCCURRED IN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OF A 79-YEAR-OLD MALE PATIENT, REQUIRING A SECONDARY INTERVENTION. ON (B)(6) 2016 (279 DAYS PRE-PROCEDURE), IMAGING REVEALED A STABLE TYPE IV THORACOABDOMINAL ANEURYSM WITH MEDIUM ILIAC ANGULATION. THE START OF THE ANEURYSM WAS LOCATED ABOVE THE RENAL ARTERY. THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 55.0 MM. ALL BRANCH VESSELS (CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), RIGHT AND LEFT RENAL ARTERIES) WERE PATENT WITH NO RENAL INFARCTS. THE INDEX PROCEDURE OCCURRED ON (B)(6) 2017, AND NO DIFFICULTIES WERE EXPERIENCED WHEN DEPLOYING THE DEVICES. POST-PROCEDURE IMAGING REVEALED NO EVIDENCE OF DEVICE INTEGRITY ISSUES OR ENDOLEAKS. THE PATIENT WAS DISCHARGED SIX DAYS POST-PROCEDURE ON (B)(6) 2017. ON (B)(6) 2017 (50 DAYS POST-PROCEDURE), THE 30-DAY FOLLOW UP CT REVEALED THE MAXIMUM ANEURYSM DIAMETER WAS 55.0 MM, WITH ALL DEVICES AND BRANCH VESSELS REMAINING PATENT. THERE WAS NO EVIDENCE OF SEPARATION OF COMPONENTS, MIGRATION OR DEVICE INTEGRITY ISSUES. THERE WAS A TYPE 3 ENDOLEAK AT THE ZENITH FENESTRATED/CUSTOM MADE FENESTRATED/BRANCHED DEVICE AND THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15162248 ↗
• MalfunctionSep 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3 ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING A FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURE. DURING THE PROCEDURE ON (B)(6) 2019, THE PATIENT RECEIVED 5 COOK DEVICES AND 2 COMPETITOR DEVICES, INCLUDING A MAIN BODY DEVICE, A DISTAL BODY DEVICE, A RIGHT ILIAC LEG GRAFT, A LEFT ILIAC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT (ZSLE-20-56-ZT), TWO COVERED STENTS, AND A VASCULAR SELF-EXPANDING STENT. IT WAS NOTED THE BILATERAL COMMON ILIACS WERE TORTUOUS (LEFT GREATER THAN THE RIGHT). AN ANGIOGRAM REVEALED THE SUPERIOR MESENTERIC ARTERY TO BE PATENT. AN AORTOGRAM SHOWED PATENCY OF THE BILATERAL RENAL ARTERY STENTS. A LEFT LOWER EXTREMITY ANGIOGRAM REVEALED PATENCY OF THE LEFT ILIAC LIMB AND LEFT ILIAC ARTERY. THE PATIENT WAS EXTUBATED IN HEMODYNAMICALLY STABLE CONDITION AND TAKEN TO THE POST ANESTHESIA CARE UNIT IN HEMODYNAMICALLY STABLE CONDITION. ON (B)(6) 2019 (2 MONTHS POST IMPLANT PROCEDURE), A CT SCAN DEMONSTRATED STABLE REPAIR WITH SLIGHT DECREASE OF THE EXCLUDED ANEURYSM SAC. SOME STENOSIS WAS NOTED IN THE SUPERIOR MESENTERIC ARTERY. ON (B)(6) 2019 (5 MONTHS POS

  Patient problems: Loss of consciousness

  MAUDE report 12529269 ↗
• MalfunctionJul 7, 2021Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  ADDITIONAL INFORMATION WAS RECEIVED ON 20JUL2021 AND 03AUG2021. IT WAS REPORTED THAT THE LEFT ILIAC LIMB IS COMPLETELY OCCLUDED. THE USER ATTRIBUTES THIS OCCLUSION TO LIKELY BE A RESULT OF DISEASE IN THE EXTERNAL ILIAC ARTERY DISTAL TO THE LIMB. PRIOR TO THE INITIAL EVAR PROCEDURE, THE PATIENT WAS TAKING 81MG OF ASPIRIN ONCE A DAY. THE PATIENT WAS REPORTED TO BE TAKING ANTIPLATELET MEDICATIONS AT THEIR POST-PROCEDURE VISIT, 6-MONTH VISIT, AND 12-MONTH VISIT. AT THEIR 2-YEAR VISIT, THE PATIENT STATED THEY WERE NOT CURRENTLY TAKING ANTIPLATELET MEDICATIONS. THE PATIENT'S DAUGHTER REPORTED THAT ONE OF THE PATIENT'S PHYSICIANS DISCONTINUED THE ASPIRIN REGIMEN FOR UNKNOWN REASONS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12131287 ↗
• InjuryJun 12, 2020Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG LOST SEAL AND MIGRATED INTO THE ANEURYSM AFTER BEING IMPLANTED IN A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6) 2017. CONSEQUENTLY, THE PATIENT REQUIRED SEVEN DAYS OF HOSPITALIZATION AND AN ADDITIONAL PROCEDURE ON (B)(6) 2020 TO RELINE THE GRAFTS. THIS WAS DISCOVERED DURING A ROUTINE CHECK-UP THROUGH A CT SCAN. IN ADDITION, THE PATIENT'S DISTAL FENESTRATED COMPONENT LOST ITS OVERLAP WITH THE PROXIMAL FENESTRATED COMPONENT, ALLOWING THE DISTAL COMPONENT TO MIGRATE DOWN AND FOLD INTO THE ANEURYSM POSTERIORLY, RESULTING IN THE DEVELOPMENT OF A TYPE III ENDOLEAK. BOTH THE RIGHT AND LEFT ILIAC LIMBS LOST SEAL WITHIN THE COMMON ILIACS, ALLOWING THE LIMBS TO MIGRATE INTO THE ANEURYSM. ONE LIMB IS THE SUBJECT OF THIS REPORT, WHILE THE OTHER LIMB CAN BE FOUND REPORTED UNDER PATIENT IDENTIFIER (B)(6). DURING REINTERVENTION, THE PHYSICIAN ACCESSED THE PATIENT'S AXILLARY ARTERY AND INSERTED AN 8FR SHEATH INTO THE AORTA. THE SUPERIOR MESENTERIC ARTERY AND THE LEFT RENAL ARTERY WERE BOTH STENTED WITH COMPETITOR GRAFTS. A WIRE WAS THEN INSERTED DOWN INTO THE PROXIMAL FENESTRATED GRAFT. THE PHYSICIAN WAS ABLE T

  Patient problems: No Code Available

  MAUDE report 10148603 ↗
• InjuryMar 1, 2018Kinked; Kinked

  IT WAS REPORTED THAT AN (B)(6), MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017. THE LATEST COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA) SHOWS PARTIAL STENOSIS OF THE RIGHT TROUSER LEG AND LEG EXTENSION. AS REPORTED, THE DOCTOR PLANS TO RELINE THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WITH ANOTHER MANUFACTURER'S BALLOON EXPANDABLE COVERED STENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Stenosis

  MAUDE report 7307411 ↗
• MalfunctionJul 25, 2017Material Frayed

  UPON OPENING THE PACKAGE, THE USER NOTICED THAT THE FRAY ON THE TIP OF THE SHEATH. ANOTHER MANUFACTURES' DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THIS WAS FOUND PRIOR TO PATIENT CONTACT, AND NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 6740769 ↗
• InjuryJun 28, 2017Occlusion Within Device; Obstruction of Flow; Occlusion Within Device; Obstruction of Flow

  ON (B)(6) 2015, UNDER GENERAL ANESTHESIA, THE PATIENT RECEIVED A MAIN-BODY GRAFT, AN IPSILATERAL (RIGHT) ILIAC LEG GRAFT, AND A CONTRALATERAL (LEFT) ILIAC LEG GRAFT. THE DEVICES WERE DEPLOYED WITHOUT DIFFICULTY. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS OR DIFFICULTIES. NO ANCILLARY COMPONENTS WERE PLACED AND NO ADDITIONAL PROCEDURES WERE PERFORMED. THERE WERE NO ADVERSE EVENTS OBSERVED DURING THE PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, THE GRAFT WAS FULLY IMPLANTED AND PATENT WITH NO KINKS. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED ON AND NO ADVERSE EVENTS WERE REPORTED. CORE LAB ANALYSIS OF THE PROCEDURE ANGIOGRAM NOTED A PATENT GRAFT WITH NO EVIDENCE OF ENDOLEAK OR KINK. ON (B)(6) 2015, A CT SCAN AND X-RAY WERE PERFORMED AT THE ONE-MONTH FOLLOW-UP VISIT. SITE ANALYSIS NOTED THE GRAFTS PATENT WITH NO ENDOLEAK. THE DEVICE WAS INTACT WITH NO EVIDENCE OF BARB SEPARATION, STENT FRACTURE, COMPONENT SEPARATION OR STENOSIS. CORE LAB ANALYSIS NOTED, GRAFTS PATENT WITH TYPE II ENDOLEAK. THE DEVICE WAS INTACT WITH NO EVIDENCE OF BARB SEPARATION, STENT FRACTURE, COMPONENT SEPARATION OR STENOSIS. ON (B)(6) 2016, THE PATIENT WAS TREATED BY PERCUTAN

  Patient problems: No Code Available; Thrombosis; Thrombosis/Thrombus

  MAUDE report 6675196 ↗
• MalfunctionAug 17, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE PATIENT HAD ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2012. THE CT DONE IN 2013 SHOWED THE LEFT LIMB WAS PATENT; HOWEVER, THE (B)(6) 2016 CT REVEALED INTERVAL OCCLUSION OF THE LEFT COMMON ILIAC LIMB. NO ADJUNCT PROCEDURES WERE DONE. PATIENT TO FOLLOW UP IN 1 YEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5882581 ↗
• InjuryMay 18, 2016Leak/Splash; Leak/Splash

  THE PHYSICIAN INSERTED A 20 MM X 56 MM ZENITH ILIAC LEG GRAFT DELIVERY SYSTEM THROUGH THE RIGHT COMMON FEMORAL ARTERY AND THE GRAFT WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY AS PER THE IFU. ON REMOVAL OF THE INNER ASSEMBLY FROM THE 20FR SHEATH THERE WAS BLOOD LEAKING FROM THE CAPTOR VALVE AFTER THE VALVE WAS IN THE CLOSED POSITION. THE DOCTOR THEN OPENED THE VALVE AND INSERTED A CODA BALLOON TO MOULD THE GRAFT SEALING ZONES. THE CODA BALLOON SLOWED DOWN THE LEAK, BUT IT WAS STILL PRESENT. ON REMOVAL OF THE CODA BALLOON FROM THE SHEATH IT WAS LEAKING BLOOD PRETTY FAST SO THE DOCTOR RE-INSERTED THE INNER ASSEMBLY OF THE ZENITH ILIAC LEG GRAFT THROUGH THE VALVE TO STOP THE LEAKING. THIS WORKED SUCCESSFULLY. THE INNER ASSEMBLY WAS LEFT IN THE SHEATH UNTIL THE SHEATH WAS REMOVED FROM THE RIGHT COMMON FEMORAL ARTERY AND THE ARTERY WAS CLOSED WITH 2 PROGLIDE SUTURES (ANOTHER MANUFACTURER) SUCCESSFULLY. THE PATIENT DID NOT RECEIVE ANY BLOOD PRODUCTS DURING THE PROCEDURE AND WAS IN A STABLE CONDITION AT THE END OF THE SUCCESSFUL PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 5662532 ↗
• MalfunctionJan 20, 2015Leak/Splash

  ALL THREE DEVICES HAD DEPLOYMENT SYSTEM LEAKS DURING THIS PROCEDURE. THE MAIN BODY (1820334-2015-00044) LEAKED SUBSTANTIALLY FROM THE CAPTOR VALVE. BOTH LEGS (1820334-2015-00043 AND 1820334-2015-00042) LEAKED SOMEWHAT FROM THE CAPTOR VALVE. ALL THREE DEVICES WERE SUCCESSFULLY IMPLANTED. NO INTERVENTION WAS REQUIRED. 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 Consequences Or Impact To Patient

  MAUDE report 4459016 ↗