Zenith Spiral-Z G55232Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10827002552323), received between Mar 4, 2015 and Jan 21, 2025 — classified as 3 deaths, 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT.

  Patient problems: Ischemia

  MAUDE report 21200719 ↗
• InjuryAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  COOK WAS NOTIFIED THAT AFTER THE PLACEMENT OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG A TYPE 1B ENDOLEAK OCCURRED. DETAILED ANESTHESIA, IMAGING, AND SURGICAL REPORTS WERE PROVIDED TO COOK INCORPORATED FOR REVIEW. THE FOLLOWING IS A SUMMARY OF THE EVENTS. THE PATIENT WAS A 66-YEAR-OLD MALE WITH A MEDICAL HISTORY OF ABDOMINAL AORTIC ANEURYSM (AAA), OBLITERATING ARTERIOPATHY OF THE LOWER LIMBS, PERSISTENT ATRIAL FIBRILLATION (ACFA), HYPERTENSION, CHRONIC RENAL INSUFFICIENCY, POLY VASCULAR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERTHYROIDISM, ARTERIAL OCCLUSIVE MESENTERIC ISCHEMIA (AOMI), ISCHEMIC HEART DISEASE WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF)<30%, AND PERIPHERAL ARTERIAL DISEASE (PAD). THE PATIENT WAS CLASSIFIED AS ASA IV IN THE ASA (ANESTHESIOLOGISTS SOCIETY OF AMERICA) CLASSIFICATION SYSTEM. ASA IV IS DEFINED FOR AN ADULT AS A PATIENT WITH SEVERE SYSTEMIC DISEASE THAT IS A CONSTANT THREAT TO LIFE. HIS LIFESTYLE INCLUDED DAILY CONSUMPTION OF ALCOHOL AND TOBACCO (ESTIMATED AT 100-PACK YEARS). THE PATIENT UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2013 FOR AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE THE FOLLOWING

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 20027986 ↗
• InjuryJul 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 21OCT2024 IN THE FORM OF AN OPERATIVE REPORT. PATIENT IS A 77 YEAR OLD CAUCASIAN MALE WITH A HISTORY OF CHF (EF 25-30%) WITH AICD, CORONARY ARTERY DISEASE STATUS POST PCI TO RCA (2017), CARDIAC ARREST 2017, HYPERLIPIDEMIA, AND SVT AL CD/PACER WHO HAS UNDERGONE STENTING AT OF HIS LEFT POPLITEAL ARTERY ANEURYSM WHO HAS A 5.5CM EXTENT IV TAAA. GIVEN THESE FINDINGS, ENDOVASCULAR REPAIR WAS RECOMMENDED TO THE PATIENT. THE RISKS AND BENEFITS OF SURGERY INCLUDING ENDOLEAK, NEED FOR REINTERVENTION, AND SPINAL CORD ISCHEMIA AMONG OTHERS WERE DISCUSSED WITH THE PATIENT. A SPINAL DRAIN WAS PLACED PREOPERATIVELY GIVEN THE ABOVE RISKS. AFTER PROPER POSITIONING OF THE PATIENT SUPINE AND OBTAINING THE NECESSARY VASCULAR ACCESS, ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS THEN PREPPED AND DRAPED IN THE USUAL STERILE FASHION AND APPROPRIATE ANTIBIOTICS WERE GIVEN. PRIOR TO BEGINNING, ANOTHER SURGICAL TIMEOUT WAS PERFORMED. UNDER ULTRASOUND GUIDANCE, A MICROPUNCTURE NEEDLE AND WIRE WERE INTRODUCED INTO THE RIGHT COMMON FEMORAL ARTERY. FLUOROSCOPY CONFIRMED WIRE WITHIN THE AORTOILIAC SYSTEM. THE MICROPUNCTURE SHEATH WAS INSERTED FOLLOWED BY A COMPETITOR'S 0.035

  Patient problems: Clinical Endoleak

  MAUDE report 19715512 ↗
• MalfunctionAug 2, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ADDITIONAL INFORMATION WAS PROVIDED ON 07AUG2023. THERE WAS NO SIGNIFICANT TORTUOSITY OF THE DISTAL AORTA, ILIAC ARTERIES AND/OR FEMORAL ARTERIES. THE PROCEDURE BEING COMPLETED WAS A FOUR VESSEL PHYSICIAN MODIFIED ENDOVASCULAR GRAFT (PMEG). THE PHYSICIAN BURNED HOLES INTO A COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY TO CREATE FENESTRATIONS. THE ILIAC LIMB GRAFTS WERE THEN PLACED INSIDE THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY PER INSTRUCTIONS FOR USE. THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE) DEVICE WAS PREPPED AS USUAL, AND UPON INSERTION IT WAS ABLE TO BE POSITIONED TO OBTAIN THE CORRECT AMOUNT OF OVERLAP WITH THE MAIN BODY. WHEN THE PHYSICIAN WENT TO DEPLOY THE GRAFT, THE GRAFT MOVED WITH THE SHEATH AND SEEMED TO BE FREE FLOATING INSIDE THE DEVICE. IT WAS IMMEDIATELY REMOVED TO PREVENT INCORRECT TARGET DEPLOYMENT. THE DEVICE MALFUNCTIONED WITH LIMITED USE. THE COOK CLINICAL SPECIALIST PRESENT FOR THE PROCEDURE DID NOT THINK THE PATIENT'S ANATOMY OR PRE-EXISTING CONDITIONS WOULD HAVE CAUSED THE DEVICE TO MALFUNCTION. THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DEVICE APPEARED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446933 ↗
• InjuryMay 18, 2023Obstruction of Flow; Obstruction of Flow

  A 77-YEAR-OLD MALE WAS DIAGNOSED WITH AN ABDOMINAL AORTIC ANEURYSM AND A LEFT ILIAC ANEURYSM. HE HAD BEEN PRESCRIBED KARDEGIC (ACETYLSALICYLIC ACID LYSINE) 75 MG. HE UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2023. THE FOLLOWING COOK DEVICES WERE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-24-82, LOT NUMBER 14841907) ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-74-ZT, LOT NUMBER 14964326) PLACED ON THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-9-122-ZT, LOT NUMBER 14830214) EXTENSION PLACED ON THE RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-16-74-ZT, LOT NUMBER 14995247) PLACED ON THE LEFT ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT A1121220) PLACED ON THE LEFT AFTER THE PROCEDURE, THE PATIENT WAS PRESCRIBED KARDEGIC 75 MG AS WELL AS LOVENOX 40 MG DURING HIS HOSPITAL STAY. AFTER DISCHARGE, THE PATIENT WAS PRESCRIBED KARDEGIC 75 MG. IT WAS REPORTED TO COOK THAT THE PATIENT HAD A RIGHT LIMB OCCLUSION AND REQUIRED A RIGHT FEMORAL ARTERY TO LEFT FEMORAL ARTERY BYPASS PROCEDURE. FLOW WAS RESTORED. THE PATI

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16953988 ↗
• InjuryFeb 3, 2023Obstruction of Flow; Obstruction of Flow

  A A 60-YEAR-OLD MALE UNDERWENT ENDOVASCULAR AORTIC REPAIR (EVAR) ON (B)(6) 2016. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE RIGHT IPSILATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-56-ZT) WAS OCCLUDED. A FEMORAL-TO-FEMORAL CROSSOVER REPAIR WAS COMPLETED TO ADDRESS THE LIMB OCCLUSION ON (B)(6) 2021. IMAGING WAS PROVIDED FOR THE INVESTIGATION FOR THE RIGHT IPSILATERAL ZSLE-13-56-ZT THAT WAS REPORTED OCCLUDED. DURING THE IMAGING REVIEW IT WAS DISCOVERED THAT THE LEFT CONTRALATERAL SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-74-ZT) PLACED ON THE LEFT, CONTRALATERAL SIDE HAD THROMBUS PRESENT IN THE PROXIMAL SEGMENT OF THE GRAFT. ADDITIONALLY, THE IMAGING REVIEW IDENTIFIED THROMBUS IN THE MAIN BODY GRAFT (ZALB-24-118). THE FOCUS OF THIS REPORT IS THE THROMBUS IDENTIFIED DURING IMAGING REVIEW IN THE PROXIMAL SEGMENT OF THE LEFT, CONTRALATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-13-74-ZT). A SEPARATE REPORT FOR THE SAME PATIENT (374043-BG) WAS SUBMITTED UNDER MDR 1820334-2022-01574 FOR THE RIGHT IPSILATERAL LEG (ZSLE-13-56-ZT) THAT WAS OCCLUDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16299201 ↗
• InjuryJun 3, 2022Partial Blockage; Fluid/Blood Leak; Partial Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT A RIGHT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG OCCLUDED FOLLOWING IMPLANTATION ON (B)(6) 2017. DURING THE INDEX PROCEDURE ON (B)(6) 2017, THE PATIENT RECEIVED A MAIN BODY DEVICE AND TWO ILIAC LEGS. ON (B)(6) 2022, THE PATIENT PRESENTED WITH RENAL COLIC. A CT SCAN REVEALED AN OCCLUDED RIGHT ZENITH ILIAC LEG GRAFT AND A TYPE 1A ENDOLEAK ON THE MAIN BODY GRAFT. AN ANGIOGRAM WAS PERFORMED AND THE GRAFT WAS RELINED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Failure of Implant; Thrombosis/Thrombus

  MAUDE report 14593690 ↗
• 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 14323212 ↗
• InjuryFeb 23, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A TYPE 3B ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE DEVICE WAS DEPLOYED BELOW THE PROXIMAL SEAL STENT AND THE GOLD MARKER. THERE WAS NO VESSEL CALCIFICATION. WHILE PERFORMING THE FINAL IMAGING RUN AFTER DEVICE PLACEMENT, IT WAS NOTICED THERE WAS CONTRAST FILLING THE ANEURYSM THROUGH THE ILIAC GRAFT. IT WAS NOTED THERE WAS A FABRIC TEAR IN THE GRAFT MATERIAL. THE DEVICE WAS RELINED WITH ANOTHER SIMILARLY SIZED DEVICE, AND THE LEAK WAS RESOLVED. THE PATIENT WAS PRESCRIBED ANTICOAGULANT OR ANTIPLATELET MEDICATION BOTH BEFORE THE INDEX EVAR PROCEDURE AND AFTER GRAFT PLACEMENT, HOWEVER THE TYPE IS UNKNOWN. THE SHAPE OF THE NECK ANATOMY WAS DESCRIBED AS PARALLEL. THE BALLOON WAS INFLATED WITH A HAND SYRINGE AT THE PROXIMAL AND DISTAL SEAL ZONE PER IFU. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587183 ↗
• MalfunctionFeb 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG USED DURING AN EVAR PROCEDURE WAS TOO SHORT, REQUIRING THE USE OF AN ADDITIONAL EXTENSION. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416375 ↗
• InjuryJun 25, 2021Complete Blockage; Complete Blockage

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

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12069447 ↗
• MalfunctionJan 29, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS A LOSS OF PATENCY IN THE LEFT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG SEEN ON THE PATIENT'S FOUR-YEAR FOLLOW-UP. PRE-PROCEDURAL IMAGING ON (B)(6) 2017 SHOWED PATENT CELIAC, SUPERIOR MESENTERIC, AND RENAL ARTERIES. THE ANEURYSM WAS CLASSIFIED AS A JUXTARENAL, STABLE ANEURYSM WITH A MAXIMUM DIAMETER OF 55MM. THERE WERE NO RENAL INFARCTS. ON (B)(6) 2017, THE PATIENT HAD SEVEN DEVICES IMPLANTED WITHOUT DIFFICULTIES DURING DEPLOYMENT, INCLUDING 3 COOK DEVICES AND 4 COMPETITOR DEVICES. POST-PROCEDURAL IMAGING SHOWED NO ENDOLEAKS, DEVICE INTEGRITY ISSUES, OR OTHER TECHNICAL OBSERVATIONS. EARLIER ON (B)(6) 2017, A SERIOUS ADVERSE EVENT WAS REPORTED OF SUSPECTED MEDULLARY ISCHEMIA DUE TO HYPOPERFUSION OF THE ADAMKIEWICZ ARTERY AFTER THE GRAFT HAD BEEN PLACED. THE PATIENT WAS TREATED WITH AN EXTERNAL LUMBAR DERIVATION, WHICH WAS CONSIDERED PROCEDURE-RELATED. AT THE ONE MONTH FOLLOW UP ON (B)(6) 2017 (44 DAYS POST-PROCEDURE), FOLLOW-UP IMAGING SHOWED PATENT ARTERIES AND NO DEVICE ISSUES. THE MAXIMUM ANEURYSM DIAMETER REMAINED 55MM. ON (B)(6) 2017 (148 DAYS POST-PROCEDURE), AN OCCLUSION OF THE RIGHT LIMB OF THE BIFURCATED BODY WAS NO

  Patient problems: Occlusion

  MAUDE report 11253174 ↗
• InjuryAug 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A TYPE 3 ENDOLEAK IN THEIR LEFT ILIAC ARTERY FOLLOWING IMPLANTATION OF TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. THE PATIENT PRESENTED WITH A RUPTURED LEFT ILIAC ARTERY ANEURYSM AND AN ARTERIOVENOUS FISTULA AT THE "CAVA / VIC", PROMPTING AN EVAR PROCEDURE WHERE FOUR GRAFTS WERE INITIALLY IMPLANTED. ADDITIONALLY, A COMPETITOR PLUG DEVICE WAS PLACED ON THE LEFT. DURING THE COMPLETION ANGIOGRAPHY AT THE END OF THE PROCEDURE, A TYPE 3 ENDOLEAK APPEARING TO BE DISTAL WAS NOTICED FROM THE LEFT ILIAC LEGS. "SELECTIVE SERIES" SUGGESTED THAT THERE WAS ADEQUATE OVERLAP BETWEEN THE COMPONENTS. IT WAS ALSO REPORTED THAT ALL COMPONENTS WERE ADEQUATELY BALANCED USING A COOK CODA BALLOON. IN RESPONSE, THE GRAFTS WERE RELINED USING A COMPETITOR DEVICE. HOWEVER, THE LEAK PERSISTED FROM ABOVE, PROMPTING A SECOND RELINING USING ANOTHER COMPETITOR DEVICE. FOLLOWING THE SECOND RELINING, THE ENDOLEAK WAS GONE. HEPARIN WAS USED DURING THE PROCEDURE. THE PATIENT WAS REPORTED TO BE "OKAY RIGHT NOW". APART FROM RELINING TWICE, NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 10451425 ↗
• DeathMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED IN A LITERATURE ARTICLE THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG CONTRIBUTED TO A TYPE 1B ENDOLEAK IN A PATIENT, RESULTING IN RUPTURE OF THE ANEURYSM AND DEATH. A (B)(6) YEAR OLD MAN WITH A 64MM JUXTARENAL ABDOMINAL AORTIC ANEURYSM WAS REPAIRED IN APRIL 2013 USING A COOK 32X124 MM PROXIMAL MAIN BODY WITH BILATERAL RENAL ARTERY FENESTRATIONS AND AN SMA SCALLOP IN A 20X45X76 MM CONFIGURATION. JUNCTIONAL OVERLAP WAS 55 MM AND NO ENDOLEAKS WERE NOTED AT THE FIRST POST-OP VISIT. AORTIC ANATOMY REMAINED STABLE UNTIL 18 MONTHS POST-OP. AT 18 MONTHS POST-OPERATION, A CONTRASTED COMPUTED TOMOGRAPHY (CT) DEMONSTRATED RESIDUAL SAC ENLARGEMENT TO 69 MM. AORTIC DUPLEX DID NOT SHOW ANY EVIDENCE OF ENDOLEAK. AT 24 MONTHS POST-OPERATION, REPEAT CTA SHOWED CONTINUED SAC EXPANSION TO 74 MM WITH A DECREASE IN MODULAR OVERLAP TO 50 MM. AORTIC DUPLEX DID NOT SHOW ANY FLOW TO THE RESIDUAL SAC. THE PATIENT OPTED TO CONTINUE NONINVASIVE IMAGING AND DEFER A DIAGNOSTIC ANGIOGRAM. AT 36 MONTHS POST-OPERATION, HIS RESIDUAL SAC WAS STABLE WITHOUT ENDOLEAK EVIDENCE. CONTINUED DECREASE IN JUNCTIONAL OVERLAP TO 37 MM SECONDARY TO PROGRESSIVE ANGULATION OF THE DI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 9806919 ↗
• DeathNov 20, 2019Fluid/Blood Leak; Device-Device Incompatibility; Fluid/Blood Leak; Device-Device Incompatibility

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

  Patient problems: Death; Rupture

  MAUDE report 9347394 ↗
• InjuryMay 9, 2019Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  ADDITIONAL INFORMATION RECEIVED ON 27MAY2019: THE DEVICE WAS NOT INSERTED BY THE NECK. THE PATIENT WAS ON HEPARIN DURING THE PROCEDURE. A CODA BALLOON WAS INFLATED TO 46CC. THERE WAS A HOLE IN THE TISSUE (FABRIC) NEAR THE STENT. ANOTHER ZSLE WAS USED - PLACED INSIDE THE ONE THAT FRACTURED TO CORRECT THE ENDOLEAK (G55233 - ZSLE-13-90). PATIENT WAS STABLE. THE PATIENT DID NOT HAVE ANY VESSEL CALCIFICATION AND/OR TORTUOSITY. THE PATIENT WAS NOT ON ANTICOAGULATION THERAPY PRIOR TO IMPLANT. THE SALES REPRESENTATIVE WAS PRESENT FOR THE CASE. NONE OF THE PROCEDURE WAS PERFORMED OFF-LABEL. THE GRAFT WAS NOT ALTERED IN ANYWAY. THERE WAS NO GRAFT OBSTRUCTION OF HIGH BLOOD PRESSURE WITHIN THE GRAFT DURING THE ENDOLEAK. IT WAS CONFIRMED IT WAS A TYPE IIIB ENDOLEAK AS THERE WAS A HOLE IN THE TISSUE, NEAR THE STENT.

  Patient problems: No Code Available

  MAUDE report 8596307 ↗
• MalfunctionMay 8, 2019Obstruction of Flow; Obstruction of Flow

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: Thrombus

  MAUDE report 8591994 ↗
• InjuryApr 24, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT WAS USED FOR INFRA-RENAL ABDOMINAL ENDOVASCULAR AORTIC REPAIR ON (B)(6) 2017. IT IS UNKNOWN IF THE PATIENT WAS ON ANTICOAGULATION THERAPY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS IMMEDIATELY FOLLOWING THIS INITIAL PROCEDURE. AN UNSPECIFIED AMOUNT OF TIME LATER, THE PATIENT BECAME SYMPTOMATIC AND WAS DIAGNOSED WITH LEG PAIN AND LIMB ISCHEMIA. THE PATIENT UNDERWENT A FEMORAL-FEMORAL CROSSOVER, WHICH RESOLVED THE ISCHEMIA. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Ischemia; No Code Available

  MAUDE report 8546944 ↗
• InjuryMar 7, 2019Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

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

  Patient problems: Aneurysm; No Code Available

  MAUDE report 8399875 ↗
• MalfunctionFeb 12, 2019Obstruction of Flow; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Pain

  MAUDE report 8331702 ↗
• InjuryFeb 16, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AN INFRA-RENAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2017. AS REPORTED THIS WAS A NORMAL EVAR WITH NO NOTED COMPLICATIONS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH LEG PAIN AND CLAUDICATION. AN EMERGENT SURGICAL FEM-FEM BYPASS WAS PERFORMED. AN OCCLUDED ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG IN THE LEFT ILIAC LIMB WAS IDENTIFIED.

  Patient problems: Claudication; No Code Available; Pain

  MAUDE report 7278167 ↗
• InjuryJul 19, 2017Leak/Splash; Leak/Splash

  AN INTERNATIONAL CUSTOMER REPORTED THAT DURING AN ILIAC LIMB EXTENSION, THERE WAS A SUSPECTED TYPE 3 ENDOLEAK OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG THAT WAS RESOLVED BY RE-LINING THE GRAFT WITH A NON-COOK DEVICE. THE PHYSICIAN SUSPECTS THERE WAS A GRAFT TEAR CAUSING THE ENDOLEAK. TYPE 3 ENDOLEAK WAS ALSO REPORTED IN THE CONTRALATERAL ILIAC LEG GRAFT, DOCUMENTED IN 1820334-2017-01508. 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 Code Available

  MAUDE report 6726458 ↗
• MalfunctionJul 18, 2017Difficult or Delayed Positioning

  IT WAS REPORTED THE STENT COULD NOT BE DEPLOYED DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DEVICE IMAGING IDENTIFIED THE SHEATH WAS ELONGATED WITH COIL AND INNER LINER EXPOSURE IN ADDITION TO THE EXPOSED COILS AND INNER LINER BEING STRETCHED ACROSS THE DILATOR WHICH COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723472 ↗
• InjuryMar 4, 2015Other (for use when an appropriate device code cannot be identified)

  ON (B)(6) 2015, THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS PLACED. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2015, PATIENT PRESENTS WITH LEFT THROMBOSIS ILIAC LEG GRAFT. PATIENT WENT TO THE OPERATING ROOM TO UNDERGO THROMBECTOMY AND SUPERVISION OF THE ENDOGRAFT. ON (B)(6) 2015, PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION.

  Patient problems: Thrombosis

  MAUDE report 4585162 ↗