Zenith FlexRecalls & reported problems across all models

We found 54 models of Zenith Flex by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 255 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2014 and Jan 16, 2025 — classified as 19 deaths, 147 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (65 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Zenith Flex problems

Zenith Flex models

54 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zenith Flex G48432

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths23 reports
• Zenith Flex G48407

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Flex G48408

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths15 reports
• Zenith Flex G48418

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Flex G48428

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  15 reports
• Zenith Flex G48417

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  14 reports
• Zenith Flex G48413

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• Zenith Flex G48402

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  11 reports
• Zenith Flex G48423

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths11 reports
• Zenith Flex G48412

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  9 reports
• Zenith Flex G48419

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  9 reports
• Zenith Flex G48422

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death9 reports
• Zenith Flex G48427

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• Zenith Flex G48433

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• Zenith Flex G48424

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• Zenith Flex G48429

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• Zenith Flex G48414

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• Zenith Flex G48415

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths4 reports
• Zenith Flex G55210

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• Zenith Flex G48403

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith Flex G48409

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith Flex G48435

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith Flex G48451

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• Zenith Flex G32182

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G32184

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G42785

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• Zenith Flex G48425

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48430

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48434

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48449

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48453

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48465

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G48478

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G55209

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G55215

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• Zenith Flex G31174

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• Zenith Flex G32179

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G32181

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G32183

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G42783

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G42787

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G42788

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48404

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48450

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48452

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48456

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48457

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48461

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48462

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G48479

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• Zenith Flex G55204

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G55205

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G55214

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• Zenith Flex G55216

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent Zenith Flex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Difficult to Remove; Difficult to Remove

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD SOME TORTUOSITY AND ATHEROMA/CALCIFICATION. THE RIGHT COMMON ILIAC ARTERY (CIA) STENT WAS IN-SITU PRIOR TO THE CASE. THE PROXIMAL TOP STENT TRIGGER WIRE WAS RELEASED PRIOR TO ADVANCEMENT OF THE TOP CAP. NO DIFFICULTY WAS EXPERIENCED WITH TOP CAP REMOVAL. IT WAS CONFIRMED THAT THE DISTAL IPSILATERAL LIMB TRIGGER WIRE WAS RELEASED PRIOR TO ADVANCEMENT OF THE TOP CAP. THE IFU WAS FOLLOWED, AND ALL TRIGGER WIRES WERE REMOVED. NO TENSION WAS FELT. ONLY ONCE THE DILATOR TIP WAS COMING DOWN INTO THE DISTAL AORTA/ILIACS WAS IT NOTICED THAT THE CANNULA AND DILATOR WERE SEPARATING. THE PIN VISE WAS CHECKED AGAIN TO MAKE SURE THAT IT WAS SECURE, AND IT DID NOT APPEAR TO BE LOOSE. WHEN TRYING TO REMOVE THE SYSTEM THROUGH THE SHEATH, THE SEPARATION WAS CONTINUED AND COULD NOT BE REMOVED. A SHORT 18F SHEATH WAS PREPARED AND A SHEATH EXCHANGE WAS MADE. THE DEVICE WAS REMOVED COMPLETELY, WITH THE SHEATH AND DILATOR/CANNULA STILL INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170735 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 07JAN2025. THE DELIVERY SYSTEM OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS FLUSHED WITH 40 CC¿S OF HEPARINIZED SALINE PRIOR TO ORIENTING THE CONTRALATERAL GATE CHECK MARK UNDER FLUOROSCOPY. THE CUSTOMER AND COOK SALES REPRESENTATIVE BELIEVED THAT IT WAS THE VALVE THAT LEAKED. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE VALVE MAY HAVE BEEN DAMAGED WHEN REMOVING THE PEEL AWAY SHEATH DURING GRAFT PREPARATION. THE SCRUB TECHNICIAN PEELED THE PEEL AWAY SHEATH APART UNTIL IT RIPPED. TYPICALLY, THE TECHNICIAN STOPS ONCE THE PEEL AWAY SHEATH REACHES THE VALVE. THEN, THE TECHNICIAN STABILIZES THE DEVICE AND SLIDES THE REMAINING PEEL AWAY SHEATH OUT OF THE VALVE BEFORE COMPLETELY REMOVING IT. BEFORE THE CATHETER COULD BE INSERTED TO MEASURE FOR IPSILATERAL LIMB, THE VALVE WAS NOTICED TO BE LEAKING AFTER REMOVING THE DILATOR. AT THIS POINT, THE VALVE WAS CLOSED AND IT STILL CONTINUED TO LEAK. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DELIVERY SYSTEM WAS REMOVED AND WAS REPLACED WITH A COMPETITOR'S SHEATH WITH THE SAME DIAMETER WHICH WAS READILY AVAILABLE IN THE OPERATING ROOM. THE PATIENT DID NOT REQUIRE A TRANS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21035172 ↗
• MalfunctionSep 13, 2024Fluid/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 20214934 ↗
• MalfunctionAug 23, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT A 76 YEAR OLD FEMALE REQUIRED A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION (ESBE-24-39-ZT) FOR A TYPE 1A ENDOLEAK FOLLOWING A PREVIOUS ABDOMINAL ENDOVASCULAR AORTIC REPAIR (EVAR). AS THE PATIENT HAD A NARROW DISTAL AORTA, ¿KISSING¿ STENTS FROM ANOTHER MANUFACTURER, MEASURING 39MM IN LENGTH AND 10MM IN DIAMETER, HAD BEEN INSERTED INTO THE CONTRALATERAL AND IPSILATERAL LIMBS AT THE TIME OF THE INDEX EVAR. WHEN THE ESBE-24-39-ZT WAS INSERTED VIA THE IPSILATERAL LIMB, IT DISLODGED THE KISSING STENT THAT WAS ALREADY IN PLACE AND CAUSED IT TO MIGRATE UP INTO THE MAIN BODY. THE PATIENT WILL REQUIRED AN ADDITIONAL PROCEDURE, BUT THE DETAILS ARE PENDING. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052174 ↗
• MalfunctionMay 10, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO COOK ON 13MAY2024 THAT THE DIFFICULT ADVANCEMENT OVER THE LUNDERQUIST WIRE HAPPENED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED OVER THE AMPLATZ WIRE IN THE SAME WAY IT WOULD HAVE OVER A LUNDERQUIST WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287934 ↗
• InjuryApr 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO DIFFICULTY IN ADVANCING THE DEVICE OR RESISTANCE OF ANY KIND REPORTED.

  Patient problems: Clinical Endoleak

  MAUDE report 19028631 ↗
• MalfunctionMar 14, 2024Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION WAS PROVIDED ON 18MAR2024 INDICATING THAT THE PATIENT'S ILIAC ARTERIES WERE NOT TORTUOUS. AS REPORTED, THE PATIENT DID NOT HAVE PRE-EXISTING CONDITIONS OR COMORBIDITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904787 ↗
• InjuryJan 9, 2024Material Separation; Activation Failure; Material Separation; Activation Failure

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

  Patient problems: Insufficient Information

  MAUDE report 18477506 ↗
• MalfunctionDec 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY FRACTURED. THE PATIENT HAD THE GRAFT PLACED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN (B)(6) 2013. THE ULTRASOUND AND X-RAY IMAGES WERE NORMAL, AND NO ISSUES WERE NOTED DURING THE FOLLOW-UP OF 2022. DURING THE 2023 FOLLOW-UP, THERE WAS NO INCREASE IN THE ANEURYSM SAC SIZE PER ULTRASOUND IMAGING. HOWEVER, THE X-RAY IMAGING SHOWED THE SUPRARENAL FIXATION AND THE SUPRARENAL RING HAD BOTH FRACTURED OFF OF THE GRAFT. UPON THIS FINDING, A COMPUTED TOMOGRAPHY (CT) SCAN HAS BEEN REQUESTED. THE POSSIBLE OPTIONS ARE UNDER CONSIDERATION TO ADDRESS THE ISSUE: FENESTRATED CUFF IF CLINICALLY SUITABLE, BRACE TOP END WITH BARE METAL STENT IF NOT TOO FIT, OR NO INTERVENTION IF THE PATIENT IS UNFIT. A DECISION WILL BE MADE ON NEXT STEP OF TREATMENT AFTER THE PHYSICIAN DISCUSSES THESE OPTIONS WITH THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE SUPRARENAL RING FRACTURE OFF OF THE GRAFT. ANOTHER REPORT WITH THE SAME PATIENT IDENTIFIER (B)(6) CAPTURES THE SUPRARENAL FIXATION FRACTURE OFF OF THE GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 18401437 ↗
• MalfunctionDec 27, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

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

  Patient problems: Insufficient Information

  MAUDE report 18401162 ↗
• DeathDec 6, 2023Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  ADDITIONAL INFORMATION WAS PROVIDED ON 05DEC2023. A COMPLETE MEDICAL RECORD WAS PROVIDED FOR REVIEW, THIS REPORT CONTAINS SPECIFICS RELATED TO THE PROCEDURE AND SUBSEQUENT EVENTS CONCERNING THE COOK GRAFT. PROCEDURE DATE: (B)(6) 2021. THE PATIENT WAS SEEN IN THE HOLDING ROOM. THE RISKS, BENEFITS, COMPLICATIONS, TREATMENT OPTIONS, AND EXPECTED OUTCOMES WERE DISCUSSED WITH THE PATIENT. THE POSSIBILITIES OF REACTION TO MEDICATION, PULMONARY ASPIRATION, PERFORATION OF VISCUS, BLEEDING, RECURRENT INFECTION, THE NEED FOR ADDITIONAL PROCEDURES, FAILURE TO DIAGNOSE A CONDITION, AND CREATING A COMPLICATION REQUIRING TRANSFUSION OR OPERATION WERE DISCUSSED WITH THE PATIENT. THE PATIENT CONCURRED WITH THE PROPOSED PLAN, GIVING INFORMED CONSENT. THE SITE OF SURGERY PROPERLY NOTED/MARKED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, IDENTIFIED AND THE PROCEDURE VERIFIED AS AAA REPAIR. A TIME OUT WAS HELD AND THE ABOVE INFORMATION CONFIRMED. GENERAL ENDOTRACHEAL ANESTHESIA WAS INITIATED AFTER PLACEMENT OF APPROPRIATE MONITORING LINES. AN ARTERIAL LINE WAS PLACED. ARMS WERE TUCKED AT THE SIDES. ALL PRESSURE POINTS WERE WELL PADDED. INTRAVENOUS ANTIBIOTICS WERE CONFIRMED. THE PATIENT WAS PREPARED

  Patient problems: Cardiac Arrest; Cardiomyopathy; Myocardial Infarction; Obstruction/Occlusion; Renal Failure; Thrombosis/Thrombus

  MAUDE report 18275905 ↗
• MalfunctionNov 16, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 22NOV2023. THE PHYSICIAN INDICATED THAT THEY ARE GOING TO GET A ONE MONTH SCAN BEFORE PROCEEDING WITH TREATMENT FOR THE POTENTIAL ENDOLEAK. THE PHYSICIAN INDICATED POTENTIAL ENDOLEAK MIGHT STILL BE A TYPE 2 ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149072 ↗
• InjurySep 15, 2023Difficult to Remove; Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Migration; Difficult to Remove; Obstruction of Flow; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION WAS PROVIDED ON 18SEP2023. AFTER PLACING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT) AND THE CONTRALATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT, LOT 15554354) THE PHYSICIAN ATTEMPTED TO DOCK THE TOP CAP OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT). HOWEVER, THE PHYSICIAN CAUGHT AN APEX OF THE BARE SUPRA RENAL STENT BETWEEN THE DILATOR AND THE SHEATH OF THE DELIVERY SYSTEM WHILE ATTEMPTING TO DOCK THE TOP CAP. THE PHYSICIAN WAS UNAWARE OF THE STENT BEING CAUGHT AND WAS UNSUCCESSFUL IN HIS ATTEMPT TO REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-26-96-ZT) MIGRATED UPWARD AND CAUSED OCCLUSION OF THE RENAL ARTERIES. THE CONTRALATERAL ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT) SEPARATED FROM THE MAIN BODY GRAFT. THE PHYSICIAN HAD TO CONVERT THE PATIENT TO AN OPEN REPAIR. A PORTION OF THE MAIN BODY GRAFT REMAINED IN THE PATIENT DURING THE OPEN REPAIR.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 17757051 ↗
• MalfunctionSep 12, 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 17730038 ↗
• 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 M

  Patient problems: Clinical Endoleak

  MAUDE report 17662370 ↗

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