Zenith Spiral-Z G55238Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10827002552385), received between Feb 25, 2016 and Aug 23, 2024 — classified as 29 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Occlusion Within Device” (10 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IN ADDITIONAL INFORMATION RECEIVED ON 23AUG2024, IT WAS REPORTED THAT THE PROCEDURE BEING PERFORMED WAS A FOUR VESSEL FENESTRATED ENDOVASCULAR REPAIR (FEVAR). THE PATIENT HAD NO PRE-EXISTING CONDITIONS OR COMORBIDITIES IN ADDITION TO THE AAA. THERE WAS NO VESSEL CALCIFICATION AND/OR TORTUOSITY IN THE AREA WHERE THE GRAFT WAS DEPLOYED. THE GRAFT WITH THE SHORTENED APPEARANCE WAS LOCATED ON THE RIGHT IPSILATERAL SIDE. NO ADDITIONAL PROCEDURES OR TREATMENTS HAVE BEEN PERFORMED AS A RESULT OF THE GRAFT SHORTENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052073 ↗
• MalfunctionJun 18, 2024Difficult 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 19559446 ↗
• MalfunctionJun 3, 2024Failure to Advance; Device-Device Incompatibility; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED TO COOK THAT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WOULD NOT ADVANCE OVER A GUIDE WIRE. A PATIENT WAS UNDERGOING A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR). A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS FLUSHED AS NORMAL. WHEN THE CLINICIAN ATTEMPTED TO ADVANCE THE GRAFT OVER THE WIRE, THE GRAFT DELIVERY SYSTEM WOULD NOT ADVANCE. THE CLINICIAN TRIED MULTIPLE TIMES, ROTATING AND USING DIFFERENT ANGLES BUT THE DELIVERY SYSTEM WOULD NOT ADVANCE. THE DEVICE WAS FLUSHED AGAIN AND THE CLINICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM AGAIN, BUT THE DELIVERY SYSTEM WOULD NOT ADVANCE OVER THE WIRE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. 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 19454440 ↗
• InjuryApr 5, 2024Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS PROVIDED ON 10SEP2024. THE PATIENT REQUIRED A DOUBLE AXILLOFEMORAL BYPASS AND THE LENGTH OF THE HOSPITALIZATION WAS VERY LONG. ADDITIONALLY, THE STAY WAS VERY COMPLICATED AFTERWARDS.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 19051956 ↗
• MalfunctionJan 30, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  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 18606220 ↗
• InjuryDec 28, 2023Partial Blockage; Device Stenosis; Partial Blockage; Device Stenosis

  IT WAS REPORTED THAT THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS FOUND TO BE COMPRESSED ON CONE BEAM CT WITH CONTRAST IMAGING FOLLOWING IMPLANTATION ON (B)(6) 2023. PRE-PROCEDURE CT WITH CONTRAST IMAGING WAS COMPLETED ON (B)(6) 2023. IT WAS FOUND THAT THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, AND CELIAC ARTERY WERE ALL PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. IT WAS ALSO FOUND THAT: SUPERIOR MESENTERIC ARTERY WAS PATENT. NO STENOSIS IDENTIFIED GREATER THAN 50%. RIGHT RENAL ARTERY WAS PATENT. NO STENOSIS IDENTIFIED GREATER THAN 50%. LEFT RENAL ARTERY WAS PATENT. NO STENOSIS IDENTIFIED GREATER THAN 50%. RIGHT COMMON ILIAC ARTERY WAS PATENT. LEFT COMMON ILIAC ARTERY WAS PATENT. RIGHT INTERNAL ILIAC ARTERY WAS PATENT. LEFT INTERNAL ILIAC ARTERY WAS PATENT. MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTER LINE WAS 68 MM. THE INTENDED PROXIMAL LANDING ZONE WAS ZONE 5, MID DESCENDING AORTA TO CELIAC. THE INTENDED DISTAL LANDING ZONE WAS ZONE 11: EXTERNAL ILIAC ARTERIES ON BOTH LEFT AND RIGHT SIDE. THE INTENDED PROXIMAL SEAL ZONE SHAPE WAS DESCRIBED A

  Patient problems: Stenosis

  MAUDE report 18409617 ↗
• InjuryMar 10, 2023Complete Blockage; Complete Blockage

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

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16522630 ↗
• InjuryFeb 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 12FEB2023, THE AREA REP CONFIRMED THAT THERE WAS NO TYPE 1B ENDOLEAK ON THE RIGHT ILIAC LEG GRAFT.

  Patient problems: Clinical Endoleak

  MAUDE report 16357515 ↗
• MalfunctionDec 7, 2022Partial Blockage; Partial Blockage

  THROMBUS WAS DISCOVERED IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE DEVICE WAS REQUIRED TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND WAS PLACED IN THE PATIENT ON THE IPSILATERAL (RIGHT) SIDE IN 2016 DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. AT THIS TIME, A MAIN BODY GRAFT AND A LEFT LEG GRAFT WERE ALSO PLACED. ABOUT FOUR YEARS LATER, IN APRIL OF 2020, LIMB OCCLUSION IF THE LEG GRAFT WAS IDENTIFIED BY THE SURGEON. AS A RESULT, A FEMORAL-FEMORAL CROSSOVER SURGERY WAS PERFORMED ON (B)(6)2022. A REVIEW OF PROVIDED POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) IMAGING NOTED THE CONTRALATERAL (LEFT) LEG GRAFT APPEARED FULLY OCCLUDED. ADDITIONALLY, THROMBUS WAS OBSERVED IN THE MIDDLE SEGMENT OF THE IPSILATERAL LIMB CAUSING LUMINAL NARROWING THAT MEASURES 6MM. THIS REPORT WILL CAPTURE THE THROMBUS OBSERVED IN THE IPSILATERAL LEG GRAFT DURING IMAGE REVIEW. THE CONTRALATERAL LEG GRAFT OCCLUSION HAS BEEN CAPTURED IN REPORT #1820334-2022-01573.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15935350 ↗
• 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 15476489 ↗
• MalfunctionApr 28, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO ADVANCE A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OVER A LUNDERQUIST WIRE DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE ON A MALE PATIENT WITH BOTH VESSEL CALCIFICATION AND TORTUOSITY. WHEN TRYING TO TRACK THE DEVICE OVER THE WIRE OUTSIDE OF THE PATIENT, IT WAS NOTED THAT THE WIRE WOULD NOT ADVANCE MORE THAN 5CM INTO THE DELIVERY SYSTEM. THE DEVICE WAS NOT IMPLANTED. THE PHYSICIAN USED ANOTHER SIMILAR DEVICE, THAT SUCCESSFULLY ADVANCED OVER THE WIRE, TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT HAS BEEN REPORTED. 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 14244450 ↗
• InjuryApr 26, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT AN OCCLUSION WAS DISCOVERED IN A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING AN INITIAL ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR). SOMETIME IN 2010, THE PATIENT RECEIVED TWO ZENITH ILIAC LEG GRAFTS AND A MAIN BODY DEVICE. AT AN UNKNOWN DATE, THE PATIENT VISITED THE PHYSICIAN AND PRESENTED WITH SIGNIFICANT ABDOMINAL AND BACK PAIN. SUBSEQUENT CT SCANS INDICATED A TYPE 1A ENDOLEAK ON THE MAIN BODY DEVICE WITH PRESSURIZATION OF A LARGE ABDOMINAL AORTIC ANEURYSM. DISTAL MIGRATION OF THE EXISTING MAIN BODY GRAFT WAS NOTED. THE PHYSICIAN INTENDS ON SEALING THE ENDOLEAK WITH A CUSOM-MADE DEVICE, ALTHOUGH A PROCEDURE HAS NOT BEEN CONFIRMED AT THIS TIME. THE CT SCAN ALSO REVEALED AN OCCLUSION ON THE ILIAC LEG GRAFT THAT WAS TREATED WITH A FEM-FEM CROSSOVER PROCEDURE PRIOR TO THE DISCOVERY OF THE TYPE 1A ENDOLEAK ON THE MAIN BODY DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THIS REPORT CAPTURES THE OCCLUSION ON THE ILIAC LEG GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 14213565 ↗
• InjuryApr 22, 2022Partial Blockage; Partial Blockage

  THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2013. AT NINE YEARS POST IMPLANT ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD IN-STENT THROMBOSIS WHICH RESULTED IN ACUTE ISCHEMIA. THE PATIENT WAS NOT PRESCRIBED AN ANTIPLATELET OR ANTICOAGULATION MEDICATION THERAPY PRIOR TO THE DISCOVERY OF THE THROMBOSIS. AFTER THE DISCOVERY OF THE THROMBOSIS, THE PATIENT WAS PLACED ON NOVEL ANTICOAGULANTS (NOAC). A RE-LINING PROCEDURE WAS SCHEDULED FOR (B)(6) 2022, THE DETAILS OF THE PROCEDURE HAVE NOT BEEN PROVIDED. HOWEVER, IT WAS REPORTED THAT THE PHYSICIAN WAS HAPPY WITH THE RESULT POST RELINING.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 14189266 ↗
• InjuryApr 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A TYPE 1B ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE. SOME TIME IN (B)(6) 2015, THE PATIENT RECEIVED FOUR SELF-EXPANDING STENTS, A CUSTOM-MADE AAA BIFURCATED GRAFT, AND THE ZENITH ILIAC LEG GRAFT. ABOUT 8 YEARS POST INDEX PROCEDURE, A TYPE 1B ENDOLEAK WAS DISCOVERED IN BOTH COMMON ILIAC ARTERIES. THE DEVICES REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT WILL BE TREATED WITH ADDITIONAL ENDOVASCULAR GRAFTS TO TREAT THE PROGRESSIVE DISEASE IN THE COMMON ILIAC ARTERIES, HOWEVER A PROCEDURE DATE HAS NOT BEEN CONFIRMED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE TYPE 1B ENDOLEAK ON THE ZENITH ILIAC LEG GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087979 ↗
• InjuryAug 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  FURTHER CLARIFICATION OF THE SEQUENCE OF EVENTS INDICATED THAT THE COMPLAINT DEVICE WAS NOT EXPLANTED, IT WAS RELINED AS PREVIOUSLY REPORTED.

  Patient problems: Aneurysm

  MAUDE report 12360363 ↗
• InjuryAug 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE III ENDOLEAK DEVELOPED FOLLOWING PLACEMENT OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PATIENT WAS DESCRIBED TO HAVE SHORT, INVERSE FUNNEL NECK ANATOMY. DURING THE INITIAL PROCEDURE, BALLOONING WAS PERFORMED IN THE SEAL ZONES, HEPARIN WAS ADMINISTERED, DEVICE LABELING WAS FOLLOWED, AND THE GRAFT WAS DEPLOYED IN THE PROPER TARGET ZONE. TWO COVERED STENTS WERE PLACED IN THE RENAL ARTERIES THROUGH FENESTRATIONS. IT WAS ALSO REPORTED THAT THE INTRA-AORTIC SEGMENT OF THE COVERED STENT WAS FLARED WITH AN OVERSIZED ANGIOPLASTY BALLOON. THE COOK REPRESENTATIVE WAS NOT INVOLVED IN THE PROCEDURE. AT A LATER TIME, AN ENDOLEAK WAS IDENTIFIED AT THE JUNCTION BETWEEN THE DISTAL FENESTRATED GRAFT AND THE CONTRALATERAL ILIAC LEG GRAFT THROUGH FOLLOW-UP CT ANGIOGRAM IMAGING. SUBSEQUENT ANGIOGRAM IMAGING REVEALED HIGHLIGHTING OF CONTRAST "NEXT TO THE CONTRALATERAL GATE JUST DISTAL TO THE BIFURCATION OF THE DISTAL BODY". IT SHOULD BE NOTED THAT THIS LOCATION IS ONLY SPECULATED DUE TO A LACK OF IMAGING, PARTICULARLY FROM THE TIME OF IMPLANTATION; HOWEVER, IT WAS REPORTED THAT THE LEAK WAS NOT NOTICED DURING THE FINAL IMAGING RUN OF THE IN

  Patient problems: Insufficient Information

  MAUDE report 12350190 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 12144520 ↗
• InjuryJun 25, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED FROM A CLINICAL STUDY THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED WHILE IMPLANTED IN A (B)(6) YEAR OLD MALE PATIENT. THE PATIENT HAD 5 OTHER GRAFTS IMPLANTED, 4 OF WHICH WERE ALSO MANUFACTURED BY COOK. THE PATIENT WAS ENROLLED IN THE STUDY DUE TO A RIGHT COMMON ILIAC ARTERY ANEURYSM SIZED 35.2 MM. THIS PATIENT WAS NOTED TO HAVE THROMBOSIS IN THE RIGHT ILIAC LEG GRAFT ON THE 2 YR CT SCAN (COMPLETED 712 DAYS POST PROCEDURE). A CORE LAB EVALUATION HAS NOT YET OCCURRED. AN INTERVENTION WAS PERFORMED TO TREAT THE OCCLUSION WHICH INVOLVED PERCUTANEOUS PLACEMENT OF A STENT AND THROMBECTOMY ON (B)(6) 2020 (712 DAYS POST-PROCEDURE). PRE-INTERVENTION THE INTERNAL ILIAC ARTERY WAS 100% STENOSED. POST-INTERVENTION THE INTERNAL ILIAC ARTERY REVEALED NO STENOSIS. THE INTERVENTION WAS CONSIDERED SUCCESSFUL AND NO OTHER ADVERSE EVENTS OR INTERVENTIONS HAVE BEEN REPORTED. THE PATIENTS PROCEDURE DATE WAS (B)(6) 2018. IT APPEARS THE PATIENT WAS TAKING ASPIRIN BEFORE THE PROCEDURE AND CONTINUES ON AFTER. HEPARIN WAS ADMINISTERED ON THE DAY OF PROCEDURE ONLY. THE PATIENT TOOK PLAVIX STARTING ON (B)(6) 2018 TO (B)(6) 2019. THE SITE INDICATED THAT

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10196777 ↗
• InjuryApr 24, 2020Use of Device Problem; Use of Device Problem

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

  Patient problems: No Code Available; Occlusion; Renal Failure

  MAUDE report 9996696 ↗
• InjuryApr 2, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED WHILE IMPLANTED IN THE PATIENT. THE PATIENT HAD TO BE TREATED WITH AN ADDITIONAL SURGICAL PROCEDURE. THE PATIENT HAS DEMENTIA AND WAS REPORTED TO BE ON ASPIRIN. THE DEVICE WAS IMPLANTED INTO A MALE PATIENT ALONG WITH A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY ON (B)(6) 2017. THERE WERE NO DIFFICULTIES EXPERIENCED IN THE INITIAL IMPLANT PROCEDURE. AT SOME POINT, THERE WAS NOTICED TO BE TOTAL OCCLUSION OF THE COMPLAINT DEVICE, WHICH WAS THE RIGHT LIMB, AS WELL AS THROMBUS FORMATION IN THE MAIN BODY GRAFT. PLEASE NOTE THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY IS NOT SOLD IN THE US. THE PATIENT WAS TREATED WITH A FEM-FEM SURGICAL BYPASS. HE WAS PUT ON ANTI-COAGULANT THERAPY UPON DISCHARGE HOME.

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 9915763 ↗
• MalfunctionOct 14, 2019Fluid/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 Known Impact Or Consequence To Patient

  MAUDE report 9187650 ↗
• InjuryAug 14, 2019Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  THE TRANSLATED RADIOLOGY REPORT WAS PROVIDED ON (B)(6) 2019 AND REVEALED THERE WAS 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 OF RUPTURE. AT THE STENT, THERE IS A PARTIAL THROMBOSIS EXTENDING TO THE START OF THE RIGHT ILIAC PROSTHESIS, WHICH IS TOTALLY THROMBOSED. EXTERNAL FEMORAL ARTERY REVASCULARIZATION WAS ACHIEVED THROUGH COLLATERAL CIRCULATION. INSUFFICIENT VASCULARIZATION WAS NOTED AT THE POPLITEAL FOSSA. THERE WAS SUFFICIENT OPACIFICATION TO THE LEFT OF THE ILIAC PROSTHESIS AND THE LEFT EXTERNAL ILIAC ARTERY IS OPACIFIED UP TO THE POPLITEAL FOSSA. ON (B)(6) 2019, THE PHYSICIAN CHECKED IF THE FEM-FEM BYPASS DONE ON (B)(6) 2019 WITH THE AESCULAP/BBRAUN GRAFT WAS NOT OCCLUDED BECAUSE NURSES REPORTED PATIENT¿S RIGHT FEET DID NOT SEEM HEALTHY. NOTHING WAS OCCLUDED ON THIS DATE. IT WAS CLARIFIED THAT THE STATEMENT, "COUNTER-ANESTHESIST INDICATION TO DEPOSIT BOTH ENDOPROTHESES BY ABDOMINAL." MEANS THE PHYSICIAN WAS INITIALLY THINKING ABOUT PERFORMING AN OPEN PROCEDURE TO EXPLANT TH

  Patient problems: Ischemia; No Code Available; Thrombus

  MAUDE report 8894779 ↗
• InjuryApr 23, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A ZALB-30-118 (RIGHT SIDE ENTRY), ZSLE-16-74-ZT (RIGHT SIDE), ZSLE-20-74-ZT (LEFT SIDE) TO REPAIR A 6.5CM ABDOMINAL AORTIC ANEURYSM (AAA). THE DOCTOR DELIBERATELY PLANNED TO LAND THE GRAFT 1CM BELOW THE RENALS IN THE MORE UNIFORM SEGMENT. ON (B)(6) 2019, THE PATIENT PRESENTED WITH AN OCCLUDED RIGHT LEG AND THROMBUS EXTENDING INTO THE RIGHT SIDE OF THE MAIN BODY. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2019. SURGICAL RE-INTERVENTION WAS PERFORMED ON SATURDAY, (B)(6) 2019. PER THE PHYSICIAN, IT WAS A TOUGH CASE. THEY LINED THE RIGHT SIDE WITH SELF-EXPANDING STENTS. PATIENT WAS ONLY ON ASPIRIN FOR ANTI-COAGULATION THERAPY AT THE TIME OF LIMB OCCLUSION. THE PHYSICIAN STATED THAT THEY BELIEVED THE MAIN FACTOR IS TORTUOSITY COMPOUNDED BY RAPID SAC SHRINKAGE. THERE IS A FAIR SPACE BETWEEN THE FABRIC AND THE RENAL ARTERIES.

  Patient problems: No Code Available; Thrombus

  MAUDE report 8542119 ↗
• MalfunctionFeb 21, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE CLINICAL STUDY PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND 1461 DAYS POST-PROCEDURE, WAS NOTED TO HAVE A KINK IN THE RIGHT ILIAC LIMB. THE PATIENT UNDERWENT EVAR ON (B)(6) 2014. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS USED. POST STENT DILATATION WAS NOT PERFORMED ON THE ATRIUM ICAST STENT. PROCEDURAL ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. (B)(6) 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). FOLLOW-UP IMAGING: (B)(6) 2014 (33 DAYS POST-PROCEDURE) CT SCAN SHOWED THE DEVICES WERE PATENT AND INTACT WITH NO KINK OR ENDOLEAK. LCIA = 30.2 MM. ON (B)(6) 2015 (186 DAYS POST-PROCEDURE) CT SCAN SHOWED THE DEVICES WERE PATENT AND INTACT WITH NO KINK, ENDOLEAK, OR MIGRATION. LCIA = 30.6 MM. ON (B)(6) 2015 (376 DAYS POST-PROCEDURE) CT SCAN SHOWED THE DEVICES WERE PATENT AND INTACT WITH NO KINK, ENDOLEAK, OR MIGRATION. LCIA = 32 MM. ON (B)(6) 2016 (736 DAYS POST-PROCEDURE) CT SCAN SHOWED THE DEVICES WERE PATENT AND INTACT WITH NO KINK, ENDOLEAK, OR MIGRATION. LCIA = 34 MM. ON (B)(6) 2017 (1097 DAYS P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359745 ↗
• InjuryNov 27, 2018Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED A (B)(6)-YEAR MALE PATIENT UNDERWENT AN EVAR PROCEDURE WHICH THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, G55238, WAS USED. PATIENT HAS A TOTAL OCCLUSION OF THE RIGHT IPSILATERAL LIMB. PATIENT DEVELOPED ACUTE LIMB ISCHEMIA AND REQUIRED A FEM-FEM CROSSOVER SURGICAL INTERVENTION. PATIENT WAS SYMPTOMATIC AND REQUIRED EMERGENT SURGERY DUE TO OCCLUSION. THE PATIENT WAS TAKING ASA AS ANTICOAGULATION/ANTIPLATELET MEDICATION. THERE WAS NOT PRE-EXISTING THROMBUS IN THE RIGHT ILIAC AND THERE WAS MINIMAL CALCIFICATION IN THE VESSELS CONTAINING THE GRAFTS. THERE WAS NO STENOSIS PRESENT IN THE VESSEL PRIOR TO DEVICE PLACEMENT AND NO EVIDENCE OF A GRAFT KINK IN THE IPSILATERAL ZSLE-16-74-ZT. THE PATIENT REPORTEDLY DID WELL POST FEM-FEM CROSSOVER.

  Patient problems: Ischemia; No Code Available

  MAUDE report 8108735 ↗