Ovation iX Iliac Stent GraftRecalls & reported problems across all models
Endologix LLC · 66 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 304
- Deaths reported
- 6
- Injuries reported
- 298
- Recalls
- 0
We found 66 models of Ovation iX Iliac Stent Graft by Endologix LLC in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2015 and Apr 30, 2026 — classified as 6 deaths, 298 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (54 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
Reports received per month, all models
Most reported Ovation iX Iliac Stent Graft problems
Device problems
- Insufficient Device Problem Information54
- Off-Label Use38
- Lack of Effect34
- Occlusion Within Device28
- Obstruction of Flow26
- Complete Blockage25
- Leak/Splash24
- Migration24
Patient problems
- Failure of Implant142
- Aneurysm57
- Clinical Endoleak53
- Occlusion51
- Stenosis41
- Obstruction/Occlusion33
- Pain21
- Ischemia15
Ovation iX Iliac Stent Graft models
66 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment12 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment11 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death10 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment10 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment10 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment9 reports
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Ovation iX Iliac Stent Graft TV-IL1414140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft TV-IL1418140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft TV-IL1422120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment7 reports
- Ovation iX Iliac Stent Graft TV-IL1416140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death6 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment6 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment6 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment6 reports
- Ovation iX Iliac Stent Graft TV-IL1410100-JSystem, Endovascular Graft, Aortic Aneurysm Treatment5 reports
- Ovation iX Iliac Stent Graft TV-IL1418160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment5 reports
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment5 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment5 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment5 reports
- Ovation iX Iliac Stent Graft TV-IL1410120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft TV-IL1410140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death4 reports
- Ovation iX Iliac Stent Graft TV-IL1412140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft TV-IL1422140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment4 reports
- Ovation iX Iliac Stent Graft TV-IL1428140-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1410160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1428120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1414120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1422160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1412160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1414160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment3 reports
- Ovation iX Iliac Stent Graft TV-IL1428160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft TV-IL1412120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft TV-IL1416120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft TV-IL1418120-JSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment2 reports
- Ovation iX Iliac Stent Graft TV-EX181845-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death1 report
- Ovation iX Iliac Stent Graft TV-EX282845-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft TV-IL1428100-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft TV-IL1418100-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft TV-IL1422100-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft TV-IL1414100-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft TV-IL1416160-JSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac ExtensionSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
- Ovation iX Iliac Stent Graft Iliac LimbSystem, Endovascular Graft, Aortic Aneurysm Treatment1 report
Recent Ovation iX Iliac Stent Graft adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Complete Blockage; Deformation Due to Compressive Stress
THE PATIENT WAS INITIALLY TREATED FOR A SMALL ABDOMINAL AORTIC ANEURYSM (AAA) AND THROMBOTIC AORTA ON (B)(6) 2026 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL STENT GRAFT AND AN OVATION IX ILIAC LIMB STENT GRAFT. THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2026 WITH A COLD LEFT LEG DUE TO LEFT ILIAC LIMB OCCLUSION WHERE THE AFX2 BSG LEG AND THE OVATION IX LIMB STENT GRAFT OVERLAPPED. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED AN ACUTE BEND. REINTERVENTION WAS COMPLETED ON (B)(6) 2026. THE PHYSICIAN ELECTED TO PERFORM A PENUMBRA (NON-ENDOLOGIX) THROMBECTOMY AND THEN RE-LINED THE AREA WITH A GORE (NON-ENDOLOGIX) VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS. NORMAL STENT GRAFT PATENCY WAS RESTORED TO THE LIMB AND PATIENT WAS DOING WELL. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE POST-SECONDARY PROCEDURE. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 25049061 ↗InjuryApr 29, 2026Obstruction of Flow
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED FOR A FUSIFORM ANEURYSM WITH A LONG NECK AND NARROW ACCESS VESSELS. THE ALTO MAIN BODY WAS DEPLOYED VIA LEFT ACCESS. THE CONTRALATERAL LEG OF THE ALTO MAIN BODY WAS ORIENTED TO THE ANTERIOR/POSTERIOR DIRECTION, RESULTING IN A CROSS-LEGGED (BALLERINA) CONFIGURATION. THE CUSTOMSEAL POLYMER FILL WAS DELIVERED WITHOUT ANY ISSUES. CONTRALATERAL CANNULATION WAS ACHIEVED SUCCESSFULLY IN APPROXIMATELY FOUR MINUTES. THE OVATION IX ILIAC LIMB STENT GRAFT WAS DEPLOYED IN THE RIGHT COMMON ILIAC ARTERY (CIA), FOLLOWED BY TOUCH-UP USING THE INTEGRATED BALLOON 14 MINUTES LATER. NEXT THE OTHER OVATION IX ILIAC LIMB STENT GRAFT WAS DEPLOYED IN THE LEFT CIA, FOLLOWED BY BALLOON TOUCH-UP. THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS OR FLOW DELAYS CONFIRMED. ROUTINE FOLLOW-UP APPROXIMATELY THREE MONTHS LATER ON (B)(6) 2026 CONDUCTED A COMPUTED TOMOGRAPHY (CT) SCAN THAT REVEALED THROMBOTIC OCCLUSION OF THE RIGHT CIA LIMB (FROM THE PROXIMAL TO THE DISTAL END) AS WELL AS OCCLUSION OF THE PROXIMAL SECTION OF THE
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 25034415 ↗InjuryMar 30, 2026Unintended Movement
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS. APPROXIMATELY FOUR (4) MONTHS AFTER POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH ABDOMINAL PAIN. AFTER AN ANGIOGRAM, A TYPE 1B ENDOLEAK WAS IDENTIFIED AS WELL AS BOTH ILIAC LIMBS HAD MIGRATED BACK INTO THE ABDOMINAL ANEURYSM. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT ONE (1) ADDITIONAL OVATION IX LIMB IN EACH ILIAC. THE FINAL PATIENT STATUS WAS REPORTED AS DOING FINE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER 3008011247-2021-00126.NOW, APPROXIMATELY FOUR AND HALF (4.5) YEARS POST THE SECONDARY REINTERVENTION PROCEDURE, A TYPE 1B ENDOLEAK WAS IDENTIFIED. THE RIGHT ILIAC LIMB APPEARS TO HAVE SLIPPED INTO THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO IMPLANT TWO OVATION IX ILIAC LIMBS BY EXTENDING INTO THE EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT DID WELL.
Patient problems: Aneurysm; Clinical Endoleak
MAUDE report 24712324 ↗InjuryMar 3, 2026Calcified; Off-Label Use; Obstruction of Flow
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP ON APPROXIMATELY (B)(6) 2026 CONDUCTED A COMPUTED TOMOGRAPHY THAT IDENTIFIED THE LEFT OVATION IX LIMB WAS STENOSED. THE PATIENT WAS COMPLAINING OF LEFT HIP PAIN. THE PHYSICIAN BALLOONED THE LEFT OVATION IX LIMB, THEN IMPLANTED A (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT TO TRY TO HELP OPEN UP THE STENOSIS. AFTER PLACING THE (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT, THE PHYSICIAN CONDUCTED AN INTRAVASCULAR ULTRASOUND TO RE-EVALUATE. REPORTEDLY, IT WAS CONFIRMED THAT THE STENT GRAFT WAS STILL STENOSED AND WOULD NOT BE ABLE TO EXPAND TO ITS FULL DIAMETER DUE TO THE CALCIUM PREVENTING FULL STENT GRAFT PATENCY. REINTERVENTION WAS COMPLETED ON (B)(6) 2026 WHERE THE PHYSICIAN CHOSE TO CONVERT TO AN AORTO-UNI ILIAC (AUI) BY IMPLANTING AN ABBOTT (NON-ENDOLOGIX) AMPLATZER VASCULAR PLUG IN THE LEFT OVATION IX LIMB TO ACHIEVE OCCLUSION. THE PHYSICIAN THEN ELECTED TO IMPLANT A GORE (NON-ENDOLOGIX) VBX STENT IN THE RIGHT OVATION IX LIMB AND EXTENDED IT PROXIMALLY TO ESTABLISH A BETTER BLOOD FLOW. AFTER CONFIRMING STRONG BLOOD FLOW OF T
Patient problems: Calcium Deposits/Calcification; Hematoma; Ischemia; Low Blood Pressure/ Hypotension; Myocardial Infarction; Pain; Stenosis
MAUDE report 24503400 ↗InjuryFeb 20, 2026Off-Label Use; Separation Problem
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, AND TWO OVATION IX EXTENDERS ON (B)(6) 2019. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THERE WAS SEPARATION OF THE OVATION IX LIMB FROM THE LEFT ILIAC CAUSING A TYPE IB ENDOLEAK. ON (B)(6) 2026 THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB TO BRIDGE THE LEFT COMMON ILIAC SEPARATION BETWEEN THE EXISTING OVATION IX ILIAC LIMB AND AFX2 BSG DEVICE LIMB. THEN A NEW AFX2 BSG WAS IMPLANTED TO HELP BRIDGE AND SEAL THE ILIAC TOGETHER. THEN AN OVATION IX EXTENDER WAS PLACED ON THE RIGHT ILIAC. THE ENDOLEAK WAS RESOLVED, THE PATIENT WAS STABLE AND LEFT THE HOSPITAL THE NEXT DAY.
Patient problems: Clinical Endoleak
MAUDE report 24402178 ↗InjuryDec 9, 2025Off-Label Use; Material Puncture/Hole; Lack of Effect; Off-Label Use; Material Puncture/Hole; Lack of Effect
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, AND AN OVATION IX EXTENDER ON (B)(6) 2018. ON (B)(6) 2025, DURING A ROUTINE FOLLOW UP, A TYPE IB ENDOLEAK FROM THE RIGHT ILIAC WAS FOUND. ON (B)(6) 2025 AN INTERVENTION OCCURRED WITH IMPLANTATION OF AN AFX2 BSG, A VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB. THE LEAK WAS RESOLVED AND THE PATIENT IS DOING GREAT. NOTE: THE AFX2 SYSTEM WAS EVALUATED USING ENDOLOGIX COMPONENTS. THE SAFETY AND EFFECTIVENESS OF OTHER STENT OR STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.
Patient problems: Clinical Endoleak
MAUDE report 23761187 ↗InjuryNov 21, 2025Migration; Lack of Effect; Migration; Lack of Effect
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM AND AN OVATION IX EXTENDER. THE PATIENT PRESENTED EMERGENTLY ON (B)(6) 2025 WITH ABDOMINAL PAIN AND A RUPTURED ANEURYSM. REPORTEDLY THE OVATION IX LIMB PULLED BACK INTO THE AORTA CAUSING A TYPE IB ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF ANOTHER OVATION IX LIMB TO EXTEND TO THE RIGHT HYPOGASTRIC. THE TYPE IB ENDOLEAK ON THE RIGHT SIDE WAS SEALED. THE PATIENTS ABDOMINAL PAIN SUBSIDED AND WAS SYMPTOM FREE. ONE WEEK LATER ON (B)(6) 2025 THE PATIENT WAS BROUGHT BACK IN TO COMPLETE AN EXTENSION ON THE LEFT COMMON ILIAC ARTERY (LCIA). THERE WAS NO ENDOLEAK PRESENT IN THE LCIA BEFORE THE PROCEDURE. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX LIMB TO EXTEND THE LCIA TO THE LEFT HYPOGASTRIC AS A PREVENTATIVE MEASURE. THE FINAL PATIENT STATUS WAS REPORTED TO BE WELL POST-SECONDARY PROCEDURES.
Patient problems: Abdominal Pain; Clinical Endoleak; Ruptured Aneurysm
MAUDE report 23618811 ↗InjuryNov 18, 2025Lack of Effect; Lack of Effect
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW-UP, THE COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED ANEURYSM ENLARGEMENT AND A TYPE 1B ON ENDOLEAK COMING FROM THE LEFT ILIAC ARTERY WITH NO SEAL FROM THE FLARED OVATION IX ILIAC LIMB. THE PHYSICIAN ELECTED TO COIL THE PATIENT'S LEFT INTERNAL ILIAC ARTERY WITH (NON-ENDOLOGIX) COILS AND IMPLANT TWO (2) OVATION IX ILIAC EXTENSIONS FROM THE AORTIC BODY LIMB DOWN INTO THE LEFT EXTERNAL ILIAC ARTERY TO CREATE A SEAL TO SUCCESSFULLY RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST THIS SECONDARY PROCEDURE AND WAS DISCHARGED HOME THE NEXT DAY.
Patient problems: Aneurysm; Clinical Endoleak
MAUDE report 23583390 ↗InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2025 WITH A POSSIBLE KIDNEY INFECTION, AND IT WAS THEN REALIZED THAT THE RIGHT COMMON ILIAC LIMB EXTENSION HAD A DISEASED ANEURYSM SEGMENT WHICH CONTINUED AND DISEASE PROGRESSION. REINTERVENTION TOOK PLACE ON (B)(6) 2025 IN WHICH THE PHYSICIAN DECIDED TO COIL EMBOLIZE THE RIGHT INTERNAL ILIAC ARTERY (RIIA) AND EXTEND THE LIMB FURTHER INTO THE EXTERNAL ILIAC ARTERY BY IMPLANTING AN OVATION IX ILIAC LIMB. THE PATIENT ALSO HAD AN EXTREMELY PATENT INFERIOR MESENTERIC ARTERY (IMA) SO THE PHYSICIAN ALSO COIL EMBOLIZED THE IMA VIA SUPERIOR MESENTERIC ARTERY. IT IS BELIEVED THAT THE PATIENT HAD A PATENT TYPE II ENDOLEAK (NON-DEVICE RELATED) WHICH WAS CAUSING THE SAC EXPANSION FROM THE IMA. THE PATIENT STATUS WAS REPORTED TO BE DOING WELL AND RECOVERING FROM THE PROCEDURE. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME FROM SUBACUTE REHAB ON POSTOPERATIVE DAY TWENTY IN FAIR CONDITION.
Patient problems: Aneurysm; Clinical Endoleak; Unspecified Infection
MAUDE report 23556185 ↗InjurySep 19, 2025Off-Label Use; Off-Label Use
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO OVATION IX ILIAC LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1B ENDOLEAK ON THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED. THE PHYSICIAN ELECTED TO IMPLANT AN OVATION IX ILIAC LIMB TO SUCCESSFULLY RESOLVE THE TYPE 1B ENDOLEAK. THE PATIENT HAS BEEN DISCHARGED HOME. NOTE: THE INITIAL AND REINTERVENTION PROCEDURES ARE OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS THE SAFETY AND EFFECTIVENESS OF OTHER STENT GRAFT DEVICES USED IN CONJUNCTION WITH THE AFX2 SYSTEM HAVE NOT BEEN ESTABLISHED.
Patient problems: Clinical Endoleak
MAUDE report 23096862 ↗InjurySep 8, 2025Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG). REPORTEDLY THE PATIENT HAD EXTENSIVE BI-LATERAL ILIAC DISEASE AS WELL WITH CALCIUM OCCLUSION. AN OVATION IX LIMB WAS PLACED ON THE RIGHT-SIDE POST AAA REPAIR AND THE EXTERNAL ILIAC WAS RUPTURED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN REPAIR IN ORDER TO FIX THE DISTAL EXTERNAL INTO THE FEMORAL WITH A GRAFT/PATCH REPAIR. PATIENT STATUS WAS STABLE AND CLOSED. APPROXIMATELY 1 HOUR LATER BEFORE LEAVING THE OPERATING ROOM THE PATIENT BECAME UNSTABLE, AND PRESSURE DROPPED. THE SURGEON RE-OPENED THE PATIENT INCISION TO INVESTIGATE AND SAW AN ILIAC TEAR HIGHER UP THAT REQUIRED ADDITIONAL OVATION IX LIMBS OVERLAPPING INTO THE AFX2 BSG LIMB. THIS COVERED THE ILIAC TEAR AND THE PATIENT WAS STABILIZED. THE FINAL PATIENT STATUS WAS REPORTEDLY STABLE. (INITIAL MDR#3008011247-2025-00047) ADDITIONAL FINDINGS DISCOVERED DURING THE CLINICAL INVESTIGATION IDENTIFIED THAT THE PATIENT RETURNED TO THE OPERATING ROO
Patient problems: Obstruction/Occlusion
MAUDE report 22993973 ↗InjuryAug 28, 2025Device Stenosis; Device Stenosis
THE PATIENT WAS IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. ON (B)(6) 2019 THE PATIENT DEVELOPED AN OCCLUDED RIGHT LIMB WITH THROMBUS IN THE RIGHT COMMON FEMORAL ARTERY ANEURYSM. THE PHYSICIAN ELECTED TO PERFORM A THROMBECTOMY OF THE RIGHT INTERNAL ILIAC ARTERY AS WELL AS IMPLANT UNKNOWN (NON-ENDOLOGIX) BILATERAL COMMON ILIAC ARTERY STENTS. THEN A RIGHT EXTERNAL ILIAC ARTERY/SUPERFICIAL FEMORAL ARTERY EMBOLECTOMY WAS PERFORMED, AN OPEN THROMBECTOMY OF THE RIGHT CORONARY FEMORAL ARTERY WAS PERFORMED, AND A VIABAHN (NON-ENDOLOGIX) STENT WAS PLACED FROM THE RIGHT SUPERFICIAL FEMORAL ARTERY TO BELOW-KNEE POPLITEAL ARTERY. THE FINAL PATIENT'S STATUS WAS REPORTED AS STABLE.
Patient problems: Obstruction/Occlusion
MAUDE report 22913272 ↗InjuryAug 13, 2025Positioning Failure; Off-Label Use; Positioning Failure; Off-Label Use
THE PATIENT WAS TREATED WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG), AN AFX VELA SUPRARENAL, TWO OVATION IX ILIAC LIMBS, AND AN OVATION IX EXTENDER ON (B)(6) 2022. APPROXIMATELY TWO YEARS AFTER THE INITIAL PROCEDURE, INTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF AN AFX2 BSG AN AFX VELA INFRARENAL, AND AN OVATION IX ILIAC LIMB TO TREAT ANEURYSM ENLARGEMENT, A TYPE IB ENDOLEAK OF THE RIGHT COMMON ILIAC (RCI) ARTERY, TYPE IIIB ENDOLEAK OF THE DISTAL MAIN BODY, AND LOSS OF OVERLAP OF THE LEFT OVATION IX ILIAC LIMB FROM THE AFX2 BSG. (REPORTED UNDER MFR# 3011063223-2024-00120). APPROXIMATELY ONE YEAR POST INTERVENTION, DURING A PROCEDURE TO TREAT AN UNRELATED HEART ISSUE, THE CATHETER PUSHED THE AFX2 BSG UP AND THE OVATION IX EXTENDER IN THE RCI SLIPPED OUT OF THE AFX2 BSG CAUSING A TYPE IB ENDOLEAK. REINTERVENTION OCCURRED ON (B)(6) 2025. REPORTEDLY, THE ILIAC WAS TORTUOUS. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO KEEP THE RIGHT ILIAC OPEN BUT FAILED AND WAS UNABLE TO PLACE A NEW, RIGHT COMMON ILIAC ARTERY GRAFT. THE PROCEDURE CONVERTED TO AN AORTO-UNI-I LIAC (AUI) WITH A LEFT TO RIGHT FEMORAL BYPASS. THE PATIENT WAS REPORTED AS HAVING NO ABDOMINAL PAIN AND
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797424 ↗InjuryJun 16, 2025Off-Label Use; Off-Label Use
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. REPORTEDLY THE PATIENT HAD EXTENSIVE BI-LATERAL ILIAC DISEASE AS WELL WITH CALCIUM OCCLUSION. AN OVATION IX LIMB WAS PLACED ON THE RIGHT-SIDE POST AAA REPAIR AND THE EXTERNAL ILIAC WAS RUPTURED. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN REPAIR IN ORDER TO FIX THE DISTAL EXTERNAL INTO THE FEMORAL WITH A GRAFT/PATCH REPAIR. PATIENT STATUS WAS STABLE AND CLOSED. APPROXIMATELY 1 HOUR LATER BEFORE LEAVING THE OPERATING ROOM THE PATIENT BECAME UNSTABLE, AND PRESSURE DROPPED. THE SURGEON RE-OPENED THE PATIENT INCISION TO INVESTIGATE AND SAW AN ILIAC TEAR HIGHER UP THAT REQUIRED ADDITIONAL OVATION IX LIMBS OVERLAPPING INTO THE AFX2 MAIN BODY LIMB. THIS COVERED THE ILIAC TEAR AND THE PATIENT WAS STABILIZED. THE FINAL PATIENT STATUS WAS REPORTEDLY STABLE.
Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Ruptured Aneurysm
MAUDE report 22213705 ↗InjuryMay 29, 2025Lack of Effect; Lack of Effect
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A PROXIMAL RIGHT ILIAC STENT COMPRESSION (GREATER THAN 50 PERCENT), BILATERAL TYPE IB ENDOLEAKS AND OUTFLOW TO THE LUMBAR ARTERIES (CLASSIFIED AS A NON-DEVICE-RELATED TYPE II ENDOLEAK). BOTH LIMBS WERE PULLED UP PROXIMALLY BEYOND THE MARGINS OF THE VERY SHORT COMMON ILIACS RESULTING IN THE BILATERAL TYPE 1B ENDOLEAKS. THE PHYSICIAN ELECTED TO RE-INTERVENE AND EXTENDED BILATERALLY WITH OVATION IX ILIAC LIMBS ON (B)(6) 2023 TO RESOLVE THIS EVENT. (REPORTED TO THE FDA ON MDR# 3008011247-2023-00067). ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED THAT THE RIGHT COMMON IS NOW ANEURYSMAL AND THE OVATION IX ILIAC LIMB NO LONGER HAS PURCHASE RESULTING IN A TYPE IB ENDOLEAK. REPORTEDLY, THE PATIENT HAD A SHORT ECTATIC COMMON ILIAC AND ON THE INITIAL ANGIOGRAM IT WAS DETERMINED THAT THE INTERNAL ILIAC ON THE RIGHT SIDE WAS NOT PATENT. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB STENT GRAFT. THE PROXIMAL PLACEMENT WAS AT
Patient problems: Clinical Endoleak
MAUDE report 22107334 ↗
Other Endologix LLC products
All Endologix LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page