Zenith Spiral-Z G55237Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10827002552378), received between Sep 22, 2016 and Jan 5, 2025 — classified as 21 injuries, 8 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2025Fluid/Blood Leak; Obstruction of Flow; Device Endoleak; Fluid/Blood Leak; Obstruction of Flow; Device Endoleak

  ADDITIONAL INFORMATION WAS PROVIDED ON 24JUL2025 REGARDING THE ADDITIONAL INTERVENTION THAT WAS COMPLETED ON (B)(6) 2025. THE PATIENT'S PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS A TYPE 1B ENDOLEAK. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE UNDER GENERAL ENDOTRACHEAL ANESTHESIA ON (B)(6) 2025. NO COMPLICATIONS WERE NOTED IN THE PROCEDURE. THE RADIATION TIME WAS 16 MINUTES. THE RADIATION EXPOSURE WAS 1138 MGY. THE TOTAL PROCEDURE TIME WAS 90 MINUTES. THE CONTRAST VOLUME USED WAS 50 ML. THE INDICATION FOR THE PROCEDURE WAS AN ENLARGEMENT OF THE RIGHT ILIAC ARTERY AND A TYPE 1B ENDOLEAK POST FENESTRATED ENDOVASCULAR REPAIR PROCEDURE IN (B)(6) 2024 WHERE A COOK ZENITH FENESTRATED PLUS GRAFT WAS PLACED IN ADDITION TO COMPETITOR'S STENTS PLACED IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, LEFT RENAL ARTERY, AND RIGHT RENAL ARTERY. FOLLOW UP IMAGING COMPLETED ONE YEAR POST OPERATIVE REVEALED ENLARGEMENT OF THE RIGHT ILIAC ARTERY AND A TYPE 1B ENDOLEAK. AT 6 MONTHS POST OPERATIVE MILD DISSECTION AT THE ILIAC BIFURCATION WAS THOUGHT TO BE FROM SHEATH EXCHANGES. OVER THE PAST FEW MONTHS ON SERIAL IMAGING WITH A TYPE 1B ENDOLEAK AND STABLE SAC SIZE, IT WAS DETERMINED THAT THE RIG

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 21076055 ↗
• MalfunctionDec 3, 2024Fluid/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 20834020 ↗
• InjuryOct 22, 2024Obstruction of Flow; Obstruction of Flow

  ADDITIONAL INFORMATION WAS PROVIDED ON 16DEC2024. THE CUSTOMER INDICATED INITIALLY THERE WAS A RIGHT ILIAC RUPTURE REQUIRING HYPOGASTRIC EMBOLIZATION AND AN ILIAC ENDOCONDUIT. POSTOPERATIVELY AN ILIAC OCCLUSION OCCURRED.

  Patient problems: Ischemia; Obstruction/Occlusion; Rupture

  MAUDE report 20507483 ↗
• MalfunctionSep 30, 2024Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; 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 20339574 ↗
• InjuryMar 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  COOK WAS INFORMED THAT A PATIENT PARTICIPATING IN A STUDY HAD A TYPE 1B ENDOLEAK ON THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC THAT WAS IDENTIFIED IN THE COMPUTED TOMOGRAPHY SCAN COMPLETED THREE DAYS POST OPERATIVE. THE PATIENT HAD SEVERAL PLANNED STAGED PROCEDURES. ON (B)(6) 2023, THE FIRST STAGED PROCEDURE, A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS COMPLETED UNDER GENERAL ANESTHESIA. A PROXIMAL AORTIC DEVICE, COOK ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (ZTA) PROXIMAL TAPERED COMPONENT (RPN: ZTA-PT-40-36-167) WAS IMPLANTED IN THE PATIENT. THE PROXIMAL SIZE OF THE AORTIC DEVICE WAS 40 MM. THE DISTAL SIZE OF THE AORTIC DEVICE WAS 36 MM AND THE LENGTH WAS 167 MM. THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THIS DEVICE. THE DELIVERY AND DEPLOYMENT OF THIS DEVICE WAS CONSIDERED SUCCESSFUL. ONE DEVICE WAS DEPLOYED. A COMPLETION ANGIOGRAM WAS PERFORMED DURING THE STAGED PROCEDURE. IMAGING WITH CONTRAST WAS COMPLETED ON 15NOV2023 (69 DAYS PRIOR TO THE CUSTOM MADE DEVICE (CMD) PROCEDURE). THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, AND CELIAC

  Patient problems: Clinical Endoleak

  MAUDE report 18960643 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT REQUIRED A SURGICAL FEMORAL ENDARTERECTOMY FOR "MOBILIZATION OF FEMORAL PLAQUES" AFTER THE PLACEMENT OF COOK DEVICES ON (B)(6) 2023. THE PATIENT WAS 62 YEARS OLD AT THE TIME OF THE CUSTOM-MADE DEVICE PROCEDURE. HE HAD BEEN DIAGNOSED WITH HYPERTENSION AND HAD HISTORY OF OPEN ABDOMINAL SURGERY. THE PATIENTS JUXTARENAL AORTIC NECK MEASURED (<10 MM). HIS ABDOMINAL AORTIC ANEURYSM (AAA) HAD A HISTORY OF GROWTH GREATER THAN OR EQUAL TO 1.0 CM/YEAR. NO REPAIR PROCEDURES HAD BEEN COMPLETED AFTER THE PRIOR ENDOVASCULAR AORTIC REPAIR (EVAR). PRE-PROCEDURE IMAGING USING CONTRAST WAS COMPLETED ON (B)(6) 2023. THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, CELIAC ARTERY WERE ALL PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE LEFT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT ACCESSORY RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. T

  Patient problems: Paresthesia; Stenosis

  MAUDE report 18627211 ↗
• InjuryDec 28, 2023Partial Blockage; Device Stenosis; Partial Blockage; Device Stenosis

  IT WAS REPORTED THAT THE RIGHT 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

  Patient problems: Stenosis

  MAUDE report 18409518 ↗
• MalfunctionDec 18, 2023Failure to Advance; Failure to Advance

  DURING A PROCEDURE, IT WAS DISCOVERED THAT THE DELIVERY SYSTEM OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS UNABLE TO ADVANCE OVER THE GUIDEWIRE. SEVERAL ATTEMPTS WERE MADE WITHOUT SUCCESS. A NEW ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OF SMALLER DIAMETER WAS USED TO COMPLETE 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 18345694 ↗
• InjuryAug 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IN 2014 A PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WHERE THE FOLLOWING COOK GRAFTS WERE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT ,LOT NUMBER 4053084); ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT NUMBER A937127) ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 4715582); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 4792180). IN 2020 A REINTERVENTION PROCEDURE WAS COMPLETED. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT LOT NUMBER 4053084) LOST WALL APPOSITION PROXIMALLY CREATING A TYPE 1A ENDOLEAK. A FENESTRATED TUBE GRAFT (MANUFACTURER UNKNOWN) WAS PLACED DURING THE SECONDARY PROCEDURE. A COMPUTED TOMOGRAPHY SCAN WAS COMPLETED ON (B)(6) 2023 AND AN ENDOLEAK WAS NOTED AND THOUGHT TO BE A TYPE 3B ENDOLEAK. AN ULTRASOUND BUBBLE TEST WAS ALSO PERFORMED AFTER THE REINTERVENTION PROCEDURE IN 2020. ON (B)(6) 2023 A REINTERVENTION PROCEDURE WAS COMPLETED WITH THE INTENTION TO RELINE THE DISTAL END OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MA

  Patient problems: Clinical Endoleak

  MAUDE report 17662065 ↗
• 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: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16522510 ↗
• InjuryJun 2, 2022Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED A POTENTIAL TYPE 1B ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE IN 2015. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO TREAT THE POTENTIAL TYPE 1B ENDOLEAK. DURING THE PROCEDURE, AN ANGIOGRAM REVEALED THE ENDOLEAK WAS DUE TO A FABRIC TEAR AT AN ANGLED SECTION OF THE LEFT ILIAC LEG DEVICE. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED. A COMPETITOR'S SHEATH WAS UNABLE TO BE ADVANCED DUE TO SCARRING, THEREFORE "BARE BACK" ADVANCEMENT OF THE LEFT ILIAC BRIDGE WAS PERFORMED TO RELINE THE ILIAC LEG DEVICE WITH AN EXTENSION GRAFT. FINAL ANGIOGRAM SHOWED FLOW DOWN THE INTERNAL ILIAC ARTERY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Failure of Implant

  MAUDE report 14573801 ↗
• InjuryFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AT THE TIME OF ENROLLMENT, PRE-PROCEDURE IMAGING CONDUCTED BY THE SITE NOTED A STABLE ABDOMINAL AORTIC ANEURYSM WITH VISCERAL ARTERY INVOLVEMENT. THE PROXIMAL SEALING ZONE SHOWED NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE BILATERAL COMMON ILIAC ARTERIES. THERE WAS MILD CALCIFICATION AND NO OCCLUSIVE DISEASE OF THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE LEFT EXTERNAL ILIAC ARTERY. THERE WAS MODERATE TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. CORE LAB ANALYSIS NOTED AN ANEURYSM DIAMETER OF 48.90 MM. THE PROXIMAL SEALING ZONE WAS PARALLEL SHAPED AND SHOWED MILD CALCIFICATION AND NO OCCLUSIVE DISEASE OR THROMBUS. THERE WAS MILD CALCIFICATION OF THE BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. THERE WAS NO OCCLUSIVE DISEASE OF THE BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. THERE WAS MODERATE TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. ON (B)(6) 2016, THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR. DURING THE PROCEDURE, THE FOLLOWING COOK DEVICES WERE IMPLANTED: ZENITH P-BRANCH ENDOVASCULAR GRAFT (RPN: PBRANCH-30-22-A LOT NUMBER AC944005X) ZENITH UNIVERSAL DISTAL BODY ENDOVAS

  Patient problems: Aneurysm

  MAUDE report 13592101 ↗
• MalfunctionMar 4, 2021Unsealed Device Packaging; Unsealed Device Packaging

  UPON OPENING THE OUTER POUCH, THE NURSE DISCOVERED A GAP IN THE SEAL OF THE INNER POUCH OF THE PACKAGE WHERE IT WAS SUPPOSED TO BE OPENED. THE PACKAGE WAS NOTED TO BE SEALED ON ALL OTHER SIDES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11416399 ↗
• InjuryNov 19, 2020Complete Blockage; Complete Blockage

  THE PATIENT PRESENTED WITH PARESTHESIA NERVE PAIN IN THE BACK WITH CLAUDICATION IN (B)(6) 2020. IN (B)(6) 2020 THE PATIENT PRESENTED WITH PAIN WHILE AT REST AND TISSUE LOSS ON THE RIGHT FOOT.

  Patient problems: Ischemia; No Code Available; Obstruction/Occlusion; Occlusion; Pain; Tissue Breakdown

  MAUDE report 10869468 ↗
• InjuryJul 17, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG HAD OCCLUDED WHILE IMPLANTED IN A PATIENT. THE PATIENT UNDERWENT A LYSE/THROMBECTOMY PROCEDURE TO REMOVE THROMBUS. A MALE PATIENT UNDERWENT REPAIR OF HIS ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2013 WITH TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS AND A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY. HIS DOCTOR LATER NOTED THAT THE CONTRALATERAL LIMB, PLACED ON THE LEFT SIDE, HAD "GONE DOWN", BUT BELIEVED THE ISSUE WAS NOT RELATED TO THE GRAFT. THE PATIENT WAS SCHEDULED TO UNDERGO A LYSE/THROMBECTOMY PROCEDURE ON (B)(6) 2020 TO REMOVE THE THROMBUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT AND EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; Thrombus

  MAUDE report 10291794 ↗
• InjuryMar 25, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG NEEDED TO BE "OPENED UP" INSIDE THE PATIENT AS THERE WAS THROMBUS NOTED INSIDE THE GRAFT. THREE COOK ZENITH DEVICES WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2019. IT WAS LATER NOTICED THAT THE LEFT LEG NEEDED TO BE OPENED UP BUT THE PHYSICIAN WASN'T SURE IF HE COULD DO SO. IN AN ADDITIONAL PROCEDURE, "THE PHYSICIAN WAS ABLE TO OPEN THE GRAFT BY USING A LYSIS PROCEDURE TO OPEN THE LEFT LIMB". THE LIMB WAS THEN EXTENDED WITH A COMPETITOR'S STENT "TO ALLOW FOR A SMOOTH LANDING ZONE". THE PATIENT IS REPORTED TO BE DOING WELL AND WENT HOME WITHOUT ISSUE. IT IS UNKNOWN WHAT MEDICATIONS THE PATIENT MAY HAVE BEEN ON. WHEN ASKED WHAT THE ISSUE WITH THE DEVICE WAS, THE CUSTOMER REPORTED "IT APPEARED TO BE THE WAY THE LIMB WAS LAYING IN THE ILIAC, BUT NO APPARENT KINK OR OCCLUSION OR ISSUE WITH THE GRAFT ITSELF". THERE WAS TORTUOSITY NOTED IN THE ILIAC THAT CONTRIBUTED TO THE WAY THE GRAFT WAS LAYING.

  Patient problems: No Code Available

  MAUDE report 9880363 ↗
• MalfunctionMar 2, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG THAT WAS IMPLANTED ON THE RIGHT SIDE OF A PATIENT "SHOWS SIGNS OF THROMBUS FORMATION". THE (B)(6) YEAR OLD MALE HAD 2 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS AND A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY IMPLANTED IN (B)(6) 2017. ON (B)(6) 2020, THE DOCTOR ASKED FOR A REVIEW OF THE PATIENT'S LATEST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN, BECAUSE THERE APPEARED TO BE THROMBUS FORMATION IN THE LEFT LIMB. UPON REVIEW OF THE IMAGING, THROMBUS FORMATION IN THE LEG WAS CONFIRMED AND THE THROMBUS APPEARED TO EXTEND INTO THE MAIN BODY. THE THROMBUS FORMATION IN THE LEFT LIMB IS REPORTED IN MDR:1820334-2020-00314. ADDITIONAL INFORMATION WAS RECEIVED ON 11FEB2020 STATING THAT THE DOCTOR ALSO BELIEVES THE RIGHT LEG SHOWS SIGNS OF THROMBUS FORMATION (SUBJECT OF THIS REPORT). AT THIS TIME IT WAS ALSO REPORTED THAT A COMPETITOR'S STENT WAS USED ON THE RIGHT SIDE FOR THE INTERNAL ILIAC ARTERY AND THAT STENT IS OCCLUDED AS WELL. THE PATIENT WAS REPORTED TO BE ON ASPIRIN AND CLOPIDOGREL PRIOR TO OR FOLLOWING THE INITIAL GRAFT PLACEMENT. THE PATIENT'S CURRENT CO

  Patient problems: Occlusion

  MAUDE report 9774977 ↗
• MalfunctionOct 3, 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 9150419 ↗
• InjuryMay 9, 2019Obstruction 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: Pain

  MAUDE report 8595830 ↗
• InjuryApr 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS INITIALLY REPORTED THE PATIENT HAD TYPE 2 AND TYPE IB ENDOLEAKS POST ENDOVASCULAR ANEURYSM REPAIR (EVAR). AN ATTEMPT TO TREAT THE ENDOLEAKS WITH COILS WAS UNSUCCESSFUL, AS THE LEAKS WERE UNABLE TO BE RESOLVED. THE ZALB-24-98 LOT: 3542292, ZSLE-16-56-ZT LOT: 4253211, AND ZSLE-20-56-ZT LOT: 2850440 WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED 12APR2019. BALLOONING WAS PERFORMED IN THE USUAL PLACES, THE AORTIC NECK, OVERLAP AND DISTAL SEAL ZONES. THE PATIENT WAS TAKING ASPIRIN AS ANTI-COAGULATION THERAPY. BECAUSE OF THE EXPANDING ABDOMINAL AORTIC ANEURYSM (AAA) DUE TO THE UNRESOLVED ENDOLEAKS, THE EVAR GRAFTS WERE EXPLANTED ON (B)(6) 2019. THE PATIENT DID FINE POST EXPLANT AND WAS DISCHARGED HOME. THIS REPORT CAPTURES THE ZSLE-16-56-ZT AND ZSLE-20-56-ZT TYPE IB ENDOLEAKS. A REPORT IS NOT BEING FILED FOR THE ZALB-24-98 ENDOLEAK, AS THIS DEVICE IS NOT SOLD IN THE US AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE US.

  Patient problems: No Code Available

  MAUDE report 8541256 ↗
• InjuryJan 31, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2015, UNDER LOCAL ANESTHESIA, THE CLINICAL STUDY PATIENT RECEIVED A MAIN-BODY GRAFT (ZALB-28-108-CI, LOT #5079291), AN IPSILATERAL (RIGHT) ILIAC LEG GRAFT (ZSLE-16-74-ZT, LOT #5782447), AND A CONTRALATERAL (LEFT) ILIAC LEG GRAFT (ZSLE-16-56-ZT, LOT #5759274). THE SITE NOTED DIFFICULTY DEPLOYING THE MAIN BODY AND NOTED ¿TRIGGER WIRE USED A LOT OF FORCE TO REMOVE¿. BILATERAL ILIAC ANGIOPLASTY WITH A NON-COMPLIANT BALLOON WAS PERFORMED WITHIN THE GRAFT AFTER GRAFT DEPLOYMENT. A MOLDING BALLOON WAS USED WITHOUT COMPLICATIONS OR DIFFICULTIES. AT THE COMPLETION OF THE PROCEDURE, THE GRAFT WAS FULLY IMPLANTED AND PATENT WITH NO ENDOLEAKS OR KINKS. THE PATIENT HAS BEEN FOLLOWED WITH SERIAL COMPUTERIZED TOMOGRAPHY (CT) SCANS (DATES (B)(6) 2015, (B)(6) 2015, (B)(6) 2016, (B)(6) 2017, AND (B)(6) 2018). ALL HAVE REPORTED A PATENT, INTACT DEVICE WITH NO REPORT OF AN ENDOLEAK OR KINK (AS REPORTED BY BOTH THE CLINICAL SITE AND CORE LAB). ON (B)(6) 2019, THE PATIENT HAD A SECONDARY INTERVENTION FOR A REPORTED TYPE I DISTAL ENDOLEAK IN THE LEFT ILIAC LEG GRAFT. THE SITE STATED ¿SMALL TYPE 1B ENDOLEAK SECONDARY TO ANEURYSMAL DEGENERATION OF THE LEFT COMMON ILIAC ARTERY

  Patient problems: No Code Available

  MAUDE report 8293915 ↗
• InjuryNov 27, 2018Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ON 19NOV2019, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THE KINK ON THE LEFT ILIAC LEG GRAFT AND WAS DESCRIBED TO BE ANGIOPLASTY INTRA-LEG STENTING. IT IS UNKNOWN IF THIS INTERVENTION WAS A NEW ADDITIONAL INTERVENTION OR THE SAME AS THE PREVIOUSLY REPORTED ADDITIONAL STENT PLACEMENT ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 8108222 ↗
• InjuryOct 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A TYPE III ENDOLEAK IN THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS NOTED; GRAFT WAS POROUS AND ALLOWED CONTRAST TO LEAK THROUGH GRAFT. THE PHYSICIAN ASSUMES IT WAS ON A SUTURE LINE. A ZSLE-13-39-ZT WAS PLACED TO SEAL LEAK. THERE WAS VERY LITTLE CALCIFICATION AND NO TORTUOSITY OF THE PATIENT'S VESSELS. IT IS UNKNOWN WHAT ANTI-PLATELET OR ANTI-COAGULATION THE PATIENT WAS ON. A CODA BALLOON WAS USED DURING THE PROCEDURE ALONG THE OVERLAP AND DISTAL END OF THE GRAFT BUT NOT OUTSIDE OF THE GRAFT. ADDITIONALLY THERE WERE NO GRAFT OBSTRUCTIONS OR HIGH BLOOD PRESSURE WITHIN THE GRAFT DURING THE ENDOLEAK. THE PROCEDURE WAS OVERALL SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 7970705 ↗
• InjurySep 10, 2018Obstruction of Flow; Obstruction of Flow

  PATIENT OUTCOME PROVIDED BY THE PHYSICIAN ON (B)(6) 2018. THE PATIENT REQUIRED A FEM-FEM BYPASS DUE TO CRITICAL LIMB ISCHEMIA WITH A ISCHEMIC NEUROPATHY AND A DROP IN ABI. PATIENT IS DOING WELL NOW.

  Patient problems: Claudication; No Code Available

  MAUDE report 7860692 ↗
• InjuryApr 11, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED A MALE PATIENT WITH AN INFRARENAL ANEURYSM UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE AND WAS IMPLANTED WITH THREE ZENITH STENTS ON (B)(6) 2014. A ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY (NOT SOLD IN US), AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. ON (B)(6) 2018, THE PATIENT PRESENTED TO HIS VASCULAR SURGEON WITH CLAUDICATION. INVESTIGATION FOUND THE PATIENT TO HAVE A THROMBOSED GRAFT FROM THE RENAL ARTERIES DOWN THROUGH BOTH COMMON ILIAC ARTERIES. THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND THE ONLY OTHER PROCEDURE HE HAD PERFORMED IN THE PREVIOUS 12 MONTHS WAS A LAMINECTOMY. THE PATIENT EXPERIENCED ADVERSE EFFECTS DUE TO THIS OCCURRENCE. PATIENT HAS SYMPTOMS OF CLAUDICATION IN HIS LEGS CURRENTLY. THE DOCTOR BOOKED THE PATIENT FOR A THROMBECTOMY ON FRIDAY, (B)(6) 2018. ON APRIL 11, 2018 VIA FOLLOW UP, ON (B)(6) 2018, ALL 3 GRAFTS WERE EXPLANTED AS THROMBUS WAS THROUGHOUT THE GRAFT SYSTEM. PATIENT RECOVERED WELL FROM THIS OPEN PROCEDURE AND HAS BEEN DISCHARGED HOME. THIS MANUFACTURER REPORT IS BEING FILED TO CAPTURE THE FIRST THROMBOSED COMMON ILIAC ARTERY. MANUFACTURER REPORT # 1820334-2018-00729 WAS F

  Patient problems: Claudication; No Code Available; Thrombosis

  MAUDE report 7422785 ↗