Zenith Spiral-Z G55239Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10827002552392), received between Sep 8, 2016 and Nov 15, 2024 — classified as 3 deaths, 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Fluid/Blood Leak; Obstruction of Flow; Deformation Due to Compressive Stress; No Apparent Adverse Event; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Deformation Due to Compressive Stress; No Apparent Adverse Event; Device Endoleak

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

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 20695015 ↗
• InjuryJul 17, 2023Fluid/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: Clinical Endoleak

  MAUDE report 17334408 ↗
• InjuryApr 7, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

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

  Patient problems: Clinical Endoleak

  MAUDE report 16704417 ↗
• InjuryAug 11, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT REQUIRED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG ON (B)(6) 2021. AT A ROUTINE SIX MONTH POST OPERATIVE APPOINTMENT, THE PATIENT REPORTED CLAUDICATION IN HIS LEFT LEG DURING AMBULATION. A CTA REVEALED THE PATIENT HAD A SIGNIFICANT STENOSIS ABOVE HIS LEFT HYPOGASTRIC ARTERY, JUST DISTAL TO THE END OF THE LEG GRAFT. THERE WAS APPROXIMATELY 80% TO 90% THROMBUS AT THE END OF HIS LEFT COMMON ILIAC ARTERY. ON (B)(6) 2022, PHYSICIAN TOOK A 7MM X 40MM ANGIOPLASTY BALLOON AND PERFORMED AN ANGIOPLASTY AT THE LEVEL OF THE STENOSIS. AFTER PERFORMING AN ANGIOGRAM RUN, THE STENOTIC AREA WAS SLIGHTLY LARGER; HOWEVER UNSATISFACTORY TO THE PHYSICIAN. A 10MM X 20MM BALLOON WAS THEN USED TO RE-ANGIOPLASTY THE SAME AREA. AFTER ANGIOPLASTY, THE STENOTIC AREA WAS SLIGHTLY BETTER; HOWEVER STILL NOT PROFOUNDLY OPEN. THE PHYSICIAN THEN UPSIZED TO A 12MM X 40MM BALLOON AND THEN PERFORMED ANOTHER ANGIOPLASTY AT THE SAME SITE. AN ANGIOGRAM REVEALED THAT THE STENOTIC AREAS WAS NOTICEABLY LARGER; HOWEVER WAS STILL TIGHT AT ABOUT 40% OPEN. THE PHYSICIAN THEN PUT IN TWO DETACHABLE COILS FROM ANOTHER MANUFACTURER INTO THE LEFT HYPOGASTRIC ARTERY TO EMBO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 15212404 ↗
• DeathMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT DIED FIVE DAYS AFTER PLACEMENT OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG GRAFT. DURING THE INDEX PROCEDURE ON (B)(6) 2022, THE PATIENT RECEIVED TWO ZENITH ILIAC LEG GRAFTS, A PROXIMAL FENESTRATED BODY GRAFT, AND A DISTAL FENESTRATED BODY GRAFT. THE PATIENT DEVELOPED RENAL FAILURE AND ABDOMINAL PAIN, BUT REFUSED TO PURSUE DIALYSIS. THE PATIENT DIED SEVERAL DAYS LATER ON (B)(6) 2022. IT IS CURRENTLY UNCLEAR IF THE ZENITH ILIAC LEG GRAFTS CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH, PROCEDURE DETAILS, PLANNING AND SIZING INFORMATION, AND PRE-EXISTING CONDITIONS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES ONE ZENITH ILIAC LEG GRAFT. THE OTHER ZENITH ILIAC LEG GRAFT INVOLVED IN THIS EVENT IS ALSO CAPTURED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: Abdominal Pain; Renal Failure

  MAUDE report 14323121 ↗
• InjuryJul 22, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12210974 ↗
• InjuryOct 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10734481 ↗
• MalfunctionSep 21, 2020Complete Blockage; Complete Blockage

  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 10563882 ↗
• InjuryJan 9, 2020Complete Blockage; Complete Blockage

  A PATIENT EXPERIENCED CRITICAL ISCHEMIA DUE TO AN OCCLUDED RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, WHICH WAS DISCOVERED IN THE IMAGE REVIEW COMPLETED FOR A RELATED EVENT FOR A ZSLE-16-74-ZT THAT WAS IMPLANTED AS WELL (REPORTED UNDER REPORT REFERENCE #1820334-2019-02014). A CUSTOM MADE BIFURCATED INFRARENAL GRAFT WITH AN INVERTED LIMB ON THE CONTRALATERAL SIDE WAS IMPLANTED AS WELL. ON (B)(6) 2019, A FEMORAL EMBOLECTOMY OF THE RIGHT BRANCH WAS PERFORMED UNSUCCESSFULLY. IT WAS NOTED THAT AN ANESTHETIST OPPOSED AN ENDOVASCULAR AORTIC REPAIR AS COMPARED TO AN OPEN SURGERY APPROACH PRIOR TO THE PROCEDURE. A DECISION WAS MADE ON (B)(6) 2019 TO PERFORM A FEMOROFEMORAL BYPASS. AFTERWARDS, THE PHYSICIAN NOTED THAT THE FEMOROFEMORAL BYPASS DID NOT SHOW SUCCESSFUL RESULTS AS THE PATIENTS RIGHT FOOT HAS NOT RESPONDED AS EXPECTED. ANOTHER SURGERY WAS PERFORMED ON (B)(6) 2019. THE PROVIDED RADIOLOGY REPORT REVEALED SUSPECTED ISCHEMIA OF THE LOWER RIGHT LIMB OF THE PREVIOUSLY IMPLANTED AORTO-ILIAC PROSTHESIS. THE EXAMINATION WAS CARRIED OUT AFTER ARTERIAL OPACIFICATION. IN THE ABDOMEN, THERE IS A SUB-RENAL ABDOMINAL ANEURYSM, 55 MM IN DIAMETER, WITH NO SIGNS O

  Patient problems: Ischemia

  MAUDE report 9570360 ↗
• DeathMar 29, 2019Leak/Splash; Leak/Splash

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: Death; No Code Available

  MAUDE report 8465439 ↗
• MalfunctionDec 3, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, IT WAS REPORTED TO WILLIAM COOK (B)(4) ((B)(4)), THAT THE PATIENT THROMBOSED A FEW DAYS AGO THE SECOND LEG OF THEIR ENDOGRAFT AND THE FEMORO-FEMORAL BYPASS. THE COMPLAINT DEVICE WAS NOT IDENTIFIED. VERY LIMITED INFORMATION WAS PROVIDED. THE COMPLAINT WAS INITIALLY LOGGED FOR THE ZLC DEVICE. THE ZLC IS NOT SOLD OR DISTRIBUTED IN THE U.S. AND THERE IS NO SIMILAR PRODUCT MARKETED IN THE U.S. THE MEDICAL DIRECTOR AT WCA SENT AN EMAIL REQUEST TO THE REPORTING PHYSICIAN TO OBTAIN MORE COMPLETE PATIENT AND EVENT DETAILS. ON (B)(6) 2018, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTING PHYSICIAN. "HE PATIENT THROMBOSED BOTH LIMBS IN A SHORT WHILE. THE GRAFT WAS REALIGNED TO ACHIEVE PATENCY. THE SECOND TIME, THE PATIENT THROMBOSED THE BODY AND THE REALIGNED LEG. HE EXPERIENCED CLAUDICATION SINCE THE BEGINNING OF THE YEAR. A CT WAS PERFORMED AND AFTER AN ANGIOGRAPHY TAKING THE PRESSURE IN THE BODY, AT THE LEG AND UNDER THE LEG. NOTHING WAS FOUND. THERE HAVE BEEN NUMEROUS ATTEMPTS MADE TO OBTAIN THE COMPLAINT DEVICE IDENTITY, ANATOMICAL LOCATION EVENT DETAILS AND PATIENT OUTCOME. AT THE TIME OF THIS REPORT, THERE HAS BEEN NO ADDITIONAL INFORMATION PROVIDED. O

  Patient problems: Claudication; Thrombosis

  MAUDE report 8124350 ↗
• 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 8091416 ↗
• InjuryJul 26, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THE PATIENT HAD A RIGHT LIMB OCCLUSION POST ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RIGHT LIMB) WAS IMPLANTED DURING THE EVAR PROCEDURE PERFORMED ON (B)(6) 2016. THE PATIENT HAS DEVELOPED PAIN AND CLAUDICATION. THE IPSILATERAL LIMB IS COMPLETELY OCCLUDED. THERE WERE NO POST IMPLANTATION OR ADJUNCTIVE PROCEDURES PERFORMED. THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION ON PATIENT TREATMENT AND PATIENT'S OUTCOME BUT HAVE NOT RECEIVED A RESPONSE AT THIS TIME.

  Patient problems: Claudication; No Code Available; Obstruction/Occlusion; Pain

  MAUDE report 7723718 ↗
• InjuryMar 12, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE, THE GOLD MARKER APPEARED FINE, HOWEVER AFTER THE DOCTOR BEGAN TO UNSHEATH THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, THE GOLD MARKER DETACHED FROM THE LEG. IT LOOKED LIKE THE GOLD MARKER IS BETWEEN THE MAIN BODY AND THE ZSLE. THE PROCEDURE WAS COMPLETED AS USUAL. THE OUTCOME OF THE PROCEDURE WAS REPORTED TO BE GOOD WITH NO ISSUES. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7330761 ↗
• MalfunctionDec 22, 2017Leak/Splash; Leak/Splash

  THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS OPENED TO PREPARE FOR A PROCEDURE. WHILE FLUSHING THE DEVICE ON THE BACK TABLE, IT WAS NOTICED THAT ALL OF THE SALINE SOLUTION WAS COMING OUT OF THE AREA WHERE THE SHEATH ATTACHES TO THE VALVE ON THE DELIVERY SYSTEM. THIS DEVICE WAS NEVER USED IN THE PROCEDURE AND WAS NOT PLACED IN PATIENT. A NEW ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS OPENED AND USED IN THE PROCEDURE AND CASE WAS COMPLETED WITHOUT INCIDENT AND PATIENT RECEIVED EXCELLENT RESULT. THERE WAS NO PATIENT CONTACT WITH THE DEVICE AS THIS OCCURRED DURING DEVICE PREPARATION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. AS REPORTED, THE PATIENT RECEIVED EXCELLENT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7141653 ↗
• InjuryDec 20, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A MALE PATIENT WITH AN AORTIC ABDOMINAL ANEURYSM (AAA) UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS INTRODUCED INTO THE CONTRALATERAL LIMB OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND DEPLOYED WITH ABOUT A 24MM OVERLAP. WHEN THE GREY DILATOR OF THE DELIVERY SYSTEM WAS RETRIEVED, IT CAUGHT ON THE TOP OF THE STENT AND MOVED IT DOWN ABOUT 12MM'S RESULTING IN NOT ENOUGH OVERLAP. AN ADDITIONAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DEPLOYED INTO THE CONTRALATERAL GATE AND LANDED DISTALLY INTO THE DEVICE, PROVIDING AN OVERLAP OF 30MM INTO THE CONTRALATERAL GATE. AT THE END OF THE CASE THE NURSING STAFF DISPOSED OF THE DELIVERY SYSTEM. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7135874 ↗
• DeathNov 17, 2017Complete Blockage; Fluid/Blood Leak; Leak/Splash; Occlusion Within Device; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Device Stenosis; Complete Blockage; Fluid/Blood Leak; Leak/Splash; Occlusion Within Device; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IN ADDITIONAL INFORMATION RECEIVED ON 25NOV2019, IT WAS REPORTED THAT THE PATIENT HAD A 2-YEAR CLINICAL ASSESSMENT ON (B)(6) 2019 WITH A COMPUTED TOMOGRAPHY (CT) SCAN. THIS SCAN REVEALED THAT THE DEVICE, CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), AND RIGHT AND LEFT RENAL WERE ALL PATENT. THE SCAN STILL SHOWED A DISTAL TYPE 1 ENDOLEAK PRESENT ON THE LEFT ILIAC LEG GRAFT. THERE WAS NO SEPARATION OF COMPONENTS, EVIDENCE OF MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2019, IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A SECONDARY INTERVENTION ON (B)(6) 2019. THIS WAS PERFORMED TO TREAT A DISTAL TYPE 1 ENDOLEAK ON THE DEVICE, INCLUDING BOTH THE LEFT AND RIGHT ILIAC LEG GRAFTS. THIS ENDOLEAK WAS FOUND ON IMAGING OBTAINED AT A 12-MONTH FOLLOW UP VISIT. TWO ANCILLARY ILIAC LEG GRAFTS FROM ANOTHER MANUFACTURER WERE PLACED, ONE ON EACH SIDE. THIS INTERVENTION WAS CONSIDERED TO BE SUCCESSFUL.

  Patient problems: Bacterial Infection; Clinical Endoleak; No Code Available; Thrombosis/Thrombus

  MAUDE report 7041154 ↗
• MalfunctionApr 18, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH A ZENITH ABDOMINAL AORTIC ANEURYSM ENDOVASCULAR GRAFT MAIN BODY. DURING THE PROCEDURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER TREATMENT DUE TO THE LEAKAGE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED NO ADVERSE EFFECTS. THIS CASE IS RELATED TO MEDWATCH WITH MFR NUMBER 1820334-2017-00691 AS THEY OCCURRED IN THE SAME PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6500733 ↗
• MalfunctionOct 11, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THIS EVENT WAS INITIALLY REPORTED UNDER MFG MEDWATCH REPORT #: 1820334-2016-00980 ON 23SEPT2016. TO MORE ACCURATELY IDENTIFY THE ASSOCIATED PRODUCT, ANOTHER MEDWATCH REPORT # 1820334-2016-00978 HAS BEEN CREATED TO CAPTURE THIS EVENT. AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2016. THE PATIENT'S ANATOMY WAS SUITABLE FOR ENDOVASCULAR REPAIR ALTHOUGH CALCIFICATION IN THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. AT THE PREPARATION THE USER OBSERVED THAT THE SALINE LEAKED FROM THE HEMOSTATIC VALVE AND THE GAP OF THE CAPTOR ROTATOR AND THE GRAY CAP, HOWEVER HE USED THE DEVICE ON THE PATIENT. THEN HE CONFIRMED CONTINUOUS BLOOD LEAKAGE FROM THE IRIS VALVE DURING THE GRAY POSITIONER WAS INSERTED IN THE VALVE, SO HE REMOVED THE DELIVERY SYSTEM AFTER PLACEMENT OF THE STENT GRAFT AND INSERTED ANOTHER MANUFACTURER'S 18FR DRYSEAL SHEATH. (1820334-2016-00980.) AFTER DEPLOYMENT OF THE CONTRALATERAL LEG AND THE SUPRARENAL STENT OF THE MAIN BODY, THE USER PLACED AN ILIAC LEG GRAFT IN THE CONTRALATERAL SIDE. THE STENT GRAFT WAS PLACED WITH STRONG ANGLE DUE TO CALCIFICATION IN THE COMMON ILIAC ARTERY. THE USER THEN INSERTED A DELIVERY SYSTEM OF ANOTHER ILIAC LEG IN THE CONTRALATER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6017667 ↗
• InjurySep 8, 2016Leak/Splash; Leak/Splash

  CLINICAL STUDY PATIENT: TYPE I ENDOLEAK 1128 DAYS POST PROCEDURE. THIS (B)(6) MALE PRESENTED AT THE TIME OF ENROLLMENT WITH A STABLE 79.3 MM AORTIC ANEURYSM. THE PROXIMAL NECK HAD AN INVERTED FUNNEL SHAPE WITH NO PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MODERATE TORTUOSITY, MILD CALCIFICATION, AND MILD OCCLUSIVE DISEASE. THE RIGHT ILIAC ARTERY HAD MILD TORTUOSITY, MILD CALCIFICATION, AND MILD OCCLUSIVE DISEASE. ON (B)(6) 2013, (DAY OF THE PROCEDURE), UNDER GENERAL ANESTHESIA, THE PATIENT RECEIVED A P-BRANCH DEVICE, A UNIVERSAL DISTAL BODY, A LEFT ILIAC LEG GRAFT, AND A RIGHT ILIAC LEG GRAFT. THE PATIENT ALSO RECEIVED A LEFT RENAL COVERED STENT, A RIGHT RENAL COVERED STENT, A RIGHT RENAL UNCOVERED STENT, AND AN SMA COVERED STENT. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE LEFT RENAL ARTERY WAS PERFORMED DUE TO "SUSPECTED COMPRESSION OR ADVANTA WITH REDILATATION DUE TO COMPRESSION", AFTER THE INDEX PROCEDURE. THERE WERE NO COMPLICATIONS OR DIFFICULTIES WITH ANY OF THE DEVICES. A MOLDING BALLOON WAS USED WITHOUT COMPLICATION. AT THE COMPLETION OF THE PROCEDURE, THE DEVICES WERE PATENT AND INTACT WITH NO EVIDENCE OF ENDOLEAK. LISTED BELOW ARE SEVERAL COMPUTED TOMOGRAPHY SCANS THE L

  Patient problems: Aneurysm; No Code Available

  MAUDE report 5935943 ↗