Alto Abdominal Stent Graft SystemRecalls & reported problems across all models
Endologix LLC · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 272
- Deaths reported
- 20
- Injuries reported
- 226
- Recalls
- 0
We found 9 models of Alto Abdominal Stent Graft System by Endologix LLC in the FDA's device registry (GUDID). Together they are named in 272 adverse event reports in the FDA's MAUDE database, received between Oct 5, 2020 and Sep 29, 2026 — classified as 20 deaths, 226 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (64 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 Alto Abdominal Stent Graft System problems
Device problems
- Lack of Effect64
- Insufficient Device Problem Information42
- Off-Label Use26
- Patient-Device Incompatibility26
- Filling Problem25
- Malposition of Device25
- Appropriate Device Problem Term/Code Not Available23
- Device Dislodged or Dislocated19
Patient problems
- Failure of Implant96
- Clinical Endoleak95
- No Clinical Signs, Symptoms or Conditions29
- Aneurysm24
- Obstruction/Occlusion24
- Low Blood Pressure/ Hypotension21
- Stenosis13
- Ischemia12
Alto Abdominal Stent Graft System models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alto™ Abdominal Stent Graft System TV-AB2980-NSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death65 reports
- Alto™ Abdominal Stent Graft System TV-AB2680-NSystem, Endovascular Graft, Aortic Aneurysm Treatment5 deaths56 reports
- Alto™ Abdominal Stent Graft System TV-AB3480-NSystem, Endovascular Graft, Aortic Aneurysm Treatment6 deaths56 reports
- Alto™ Abdominal Stent Graft System TV-AB2380-NSystem, Endovascular Graft, Aortic Aneurysm Treatment4 deaths48 reports
- Alto™ Abdominal Stent Graft System TV-AB2080-NSystem, Endovascular Graft, Aortic Aneurysm Treatment20 reports
- Alto™ Abdominal Stent Graft System TV-AB2680-NSystem, Endovascular Graft, Aortic Aneurysm Treatment8 reports
- Alto™ Abdominal Stent Graft System TV-AB3480-NSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death8 reports
- Alto™ Abdominal Stent Graft System TV-AB2980-NSystem, Endovascular Graft, Aortic Aneurysm Treatment2 deaths7 reports
- Alto™ Abdominal Stent Graft System TV-AB2380-NSystem, Endovascular Graft, Aortic Aneurysm Treatment1 death4 reports
Recent Alto Abdominal Stent Graft System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Lack of Effect
Patient problems: Aneurysm; Clinical Endoleak
MAUDE report 50932563 ↗InjurySep 25, 2026Off-Label Use
The patient was implanted with the Alto Abdominal Stent Graft system to treat an abdominal aortic aneurysm (AAA) on (b)(6) 2026. During this initial procedure, a type IA endoleak was identified and treated with a Palmaz stent (non-Endologix). It was reported that the case was borderline on-label, the patient was not an open surgical candidate, and had no other treatment options. The patient was reported as doing fine, was expected to be discharged one day post-op, and scheduled for a 30-day follow-up. After the initial report, clinical assessment determined that the type IA endoleak was not resolved by the Palmaz stent; however, it is unknown if the 30-day follow-up was performed to determine if the endoleak ultimately resolved.
Patient problems: Clinical Endoleak
MAUDE report 50897181 ↗InjuryAug 13, 2026Off-Label Use; Obstruction of Flow
Patient problems: Bacterial Infection; Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 50240493 ↗InjuryJun 9, 2026Material Puncture/Hole
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 ANEURYSM GROWTH WAS FOUND. THE COMPUTED TOMOGRAPHY (CT) REVEALED A POSSIBLE TYPE IIIB ENDOLEAK BETWEEN THE ALTO MAIN BODY STENT GRAFT AND THE OVATION IX ILIAC LIMB AS WELL AS AN INDETERMINATE ENDOLEAK COMING FROM AROUND THE AORTIC NECK OF THE ALTO MAIN BODY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. THE PHYSICIAN ELECTED TO IMPLANT (NON-ENDOLOGIX) COVERED STENTS EXTENDING THE PROXIMAL ILIAC LIMBS TO COVER THE ENDOLEAKS. THE FINAL PATIENT STATUS WAS NOT REPORTED.
Patient problems: Aneurysm; Clinical Endoleak; Stenosis; Thrombosis/Thrombus
MAUDE report 25446033 ↗InjuryMay 8, 2026Fluid/Blood Leak; Material Integrity Problem
THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT THE DURING THE PROCEDURE A POLYMER LEAK WAS SUSPECTED. FOLLOWING THE DEPLOYMENT OF THE ALTO BIFURCATED STENT GRAFT VIA A RIGHT APPROACH PER THE STANDARD PROCEDURE, THE POLYMER KIT WAS CONNECTED, AND POLYMER INJECTION WAS PERFORMED. POLYMER WAS INJECTED INTO ALL RINGS; THE IPSILATERAL RING, SEALING RING, SUPPORT RING, CONTRALATERAL RING, AND THE PROCEDURE MOVED TO CONTRALATERAL CANNULATION. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE FILL SYRINGE CONNECTED TO THE FILL CONNECTOR BOTTOMED OUT ALTHOUGH POLYMER SHOULD HAVE REMAINED IN IT. SUSPECTING A POLYMER LEAK, THE PHYSICIAN CLAMPED THE FILL CONNECTOR TUBE WITH FORCEPS. SIMULTANEOUSLY, THE PATIENT¿S BLOOD PRESSURE DROPPED ACUTELY TO THE 50S. THE ANESTHESIOLOGIST ADMINISTERED NOREPINEPHRINE, AND ALTHOUGH IT TOOK SOME TIME, THE BLOOD PRESSURE RECOVERED TO THE 100S. THE PROCEDURE WAS CONTINUED, AND AFTER 14 MINUTES, TOUCH-UP WAS PERFORMED USING THE INTEGRATED BALLOON. THE CONTRALATERAL LIMB AND THE IPSILATERAL LIMB WERE DEPLOYED, THEN TOUCH-UPS WERE PERFORMED AT THE JUNCT
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 25125946 ↗InjuryMar 31, 2026Malposition of Device
THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM WHICH RESULTED IN UNTREATED RIGHT RENAL OCCLUSION. THE ALTO MAIN BODY DELIVERY SYSTEM WAS INSERTED VIA A RIGHT APPROACH. THE RENAL ARTERIES WERE CONTRAST-IMAGED TO IDENTIFY THEIR APPROXIMATE LOCATIONS. AFTER THE MID-CROWN OF THE ALTO MAIN BODY WAS DEPLOYED, BALLOON EXPANSION WAS PERFORMED. FOLLOWING PARALLAX ADJUSTMENT, RENAL ARTERY ANGIOGRAPHY WAS PERFORMED AGAIN. AFTER INJECTING THE POLYMER FILL AND CONFIRMING THAT THE SEALING RING POSITION WAS APPROPRIATE, THE PROXIMAL CROWN WAS DEPLOYED. CONTRALATERAL CANNULATION WAS PERFORMED USING THE CROSSOVER LUMEN. FOURTEEN MINUTES LATER, BALLOON EXPANSION WAS CARRIED OUT FOR TWO MINUTES. AT THIS POINT, IT WAS OBSERVED THAT THE ALTO MAIN BODY SEALING RING WAS SLIGHTLY OVERLAPPING THE RIGHT RENAL ARTERY, AND THE BLOOD FLOW IN THE RIGHT RENAL ARTERY WAS DELAYED; THEREFORE, CORRECTIVE ACTION WAS TAKEN. A SHEATH WAS INSERTED VIA THE LEFT ARM, AND AN ATTEMPT WAS MADE TO CANNULATE THE RENAL ARTERY, BUT IT WAS UNSUCCESSFUL. FOLLOW-UP ANGIOGRAPHY REVEALED THAT THE RENAL ARTERY WAS COMPLETELY OCCLUDED. WHEN CANNULATION WA
Patient problems: Obstruction/Occlusion
MAUDE report 24744067 ↗InjuryMar 30, 2026Device Stenosis
THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY WERE EMBOLIZED WITH COILS. A GORE (NON-ENDOLOGIX) 26X33 CUFF WAS DEPLOYED TO EMBOLIZE THE PROXIMAL LUMBAR ARTERY. THE ALTO MAIN BODY WAS DEPLOYED VIA RIGHT ACCESS. CONTRALATERAL CANNULATION WAS COMPLETED WITHIN 7 MINUTES OF DEPLOYMENT. THE CONTRALATERAL OVATION IX ILIAC LIMB WAS DEPLOYED. BALLOON TOUCH UP WAS PERFORMED AT FOURTEEN MINUTES ON THE PROXIMAL PORTION OF THE ALTO MAIN BODY, FOLLOWED BY THE DEPLOYMENT OF THE IPSILATERAL OVATION IX ILIAC LIMB. AFTER BALLOONING THE JUNCTIONS BETWEEN THE LIMBS AND THE ALTO MAIN BODY, THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS. FOLLOWING DISCHARGE, ON (B)(6) 2026, THE PATIENT COMPLAINED OF LEFT LEG PAIN. EXAMINATION REVEALED STENOSIS IN THE PROXIMAL PORTION OF THE LEFT LEG OF THE ALTO MAIN BODY. THE STENOSIS WAS TREATED WITH DEPLOYMENT OF A BARE METAL STENT (NON-ENDOLOGIX), AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE POSITIONING HEIGHT OF THE LEFT AND RIGHT LIMBS DIFFERED BY APPROXIMATELY ONE MARKER. THE STENOSIS WAS LIKELY TO HAVE OCCURRED BECAUSE THE ANATOMY AT IR+40 BEING RELATIVELY NARROW AND THERE WAS I
Patient problems: Pain; Stenosis
MAUDE report 24715120 ↗InjuryMar 19, 2026Migration
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM WITH A RIGHT RENAL CHIMNEY STENT (NON ENDOLOGIX) ON (B)(6) 2024 FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THIRTY DAYS POST PROCEDURE, THE RIGHT RENAL STENT BECAME OCCLUDED. THE PATIENT WAS ADMITTED, AND THE RIGHT RENAL CHIMNEY WAS ACCESSED FROM THE GROIN, FOLLOWED BY PERCUTANEOUS MECHANICAL THROMBECTOMY. THE CHIMNEY STENT (NON ENDOLOGIX) WAS SUBSEQUENTLY EXTENDED DISTALLY. DUE TO PROCEDURAL MANIPULATION, THE ALTO MAIN BODY SHIFTED, RESULTING IN A TYPE IA ENDOLEAK IDENTIFIED ON THE FINAL ANGIOGRAM. THE PATIENT WAS DISCHARGED GIVEN THE HIGH CONTRAST LOAD AND THE TEMPORARY PERIOD OF RENAL MALPERFUSION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AT THE END OF (B)(6) 2026. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION. MEDTRONIC ENDURANT AORTIC CUFF (NON ENDOLOGIX), A RIGHT RENAL PERISCOPE STENT (NON ENDOLOGIX), A LEFT RENAL CHIMNEY STENT (NON ENDOLOGIX), AND COIL EMBOLIZATION OF THE ANEURYSM SAC (NON ENDOLOGIX) WERE PLACED. THE TYPE IA ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT HAS REMAINED ASYMPTOMATIC THROUGHOUT THE COURSE OF TREATMENT, WITH THE EXCEPTION OF THE INITIAL RENAL STENT OCCLUSION. FOLLOWI
Patient problems: Clinical Endoleak; Obstruction/Occlusion
MAUDE report 24645817 ↗InjuryMar 6, 2026Fluid/Blood Leak; Material Integrity Problem
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. DURING THIS INITIAL PROCEDURE, THE ALTO MAIN BODY WAS DEPLOYED VIA THE RIGHT APPROACH. THE POLYMER KIT WAS CONNECTED TO INJECT THE POLYMER. PRIOR TO THE PROCEDURE THE BLOOD PRESSURE WAS 113/50. AFTER COMPLETION OF THE POLYMER FILL, HYPOTENSION WAS OBSERVED WITH A BLOOD PRESSURE OF 40/30 AND THE HEART RATE REMAINED AT APPROXIMATELY 100BPM. ONLY THE BLOOD PRESSURE DECREASED. THE BLOOD PRESSURE NORMALIZED APPROXIMATELY 10-15 MINUTES AFTER TREATMENT BY ANESTHESIA WITH EPHEDRINE HYDROCHLORIDE, NEOSYNEPHRINE, EPINEPHRINE AND POLARAMINE AND THE PROCEDURE WAS CONTINUED. THE BILATERAL LIMBS WERE PLACED AND THE PROCEDURE WAS COMPLETED.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24539293 ↗InjuryMar 5, 2026Lack of Effect
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP, A TYPE IA ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2026 THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT (NON-ENDOLOGIX) BUT IT COULD NOT BE DELIVERED. THE PHYSICIAN ELECTED TO FILL THE SAC WITH COILS (NON-ENDOLOGIX) AND THE ENDOLEAK WAS RESOLVED.
Patient problems: Clinical Endoleak
MAUDE report 24522231 ↗InjuryMar 3, 2026Fluid/Blood Leak; Material Puncture/Hole
THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THE GRAFT WAS PLACED BELOW THE LOWEST LEFT RENAL AND THE POLYMER WAS MIXED WITH 20 STROKES. THE POLYMER WAS CONNECTED WITHIN LESS THAN A MINUTE AND WAITED TO FILL THE RINGS. AFTER FIVE (5) MINUTES OF FULLY FILLING THE RINGS THE ANESTHESIOLOGIST MENTIONED THE PATIENT¿S BLOOD PRESSURE PLUMMETED AND INQUIRED IF THE ILIAC ARTERY WAS RUPTURED. IT WAS NOTED THAT THE POLYMER SYRINGE WAS NOTED TO HAVE BOTTOMED OUT. THE PHYSICIAN TOOK A CONTRAST RUN WHICH DID NOT SHOW ANY EXTRAVASATION. THE ANESTHESIOLOGIST WAS REQUESTED TO ADMINISTER EPINEPHRINE, BENADRYL AND STEROIDS TO TREAT FOR A POLYMER ALLERGIC REACTION. THE PATIENT WAS STABILIZED AND THE PROCEDURE WAS CONTINUED WITH PLACEMENT OF THE ILIAC LIMBS AND THE AAA WAS SEALED. THE PATIENT WAS EXTUBATED AND SENT TO THE INTENSIVE CARE UNIT (ICU).
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24502641 ↗InjuryFeb 25, 2026Filling Problem; Improper or Incorrect Procedure or Method
THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. DURING THE PROCEDURE, THE CONTRALATERAL LIMB DID NOT FULLY FILL WITH POLYMER. THE PHYSICIAN ATTEMPTED TO PUSH AND PULL ON THE HANDLE (OFF LABEL USE), BUT THE POLYMER WOULD NOT ADVANCE. THE PHYSICIAN THEN TRIED PUTTING A LITTLE EXTRA PRESSURE ON THE SYRINGE (OFF LABEL USE), BUT IT CAUSED THE RINGS TO DELAMINATE. A KELLY CLAMP WAS PLACED ON THE POLYMER TO ENSURE THAT POLYMER WOULDN¿T BE INJECTED INTO THE PATIENT IF THERE WAS AN OPENING. ANESTHESIOLOGIST WAS NOTIFIED IN CASE THERE WAS ANAPHYLACTIC REACTION. THE PHYSICIAN USED THE CROSSOVER LUMEN TO PLACE THE CONTRALATERAL LIMB. BALLOONING OF THE RINGS WAS DONE WITH LIGHT PRESSURE. THE REST OF THE PROCEDURE WENT WELL WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM. THERE WERE NO ADVERSE PATIENT EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24443953 ↗DeathFeb 24, 2026Positioning Failure; Filling Problem; Off-Label Use; Short Fill
THE PATIENT WAS BEING TREATED WITH ENDOVASCULAR REPAIR SINCE THEY WEREN'T A SURGICAL CANDIDATE DURING AN OFF-LABEL CASE ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM IN COMPLEX ANATOMY. REPORTEDLY THE PATIENT HAD PREVIOUS (NON-ENDOLOGIX) ILIAC STENTS GRAFTS PLACED IN BOTH COMMON ILIACS APPROXIMATELY TEN-ELEVEN (10-11) YEARS PRIOR THAT EXTENDED INTO THE AORTA BUT STOPPED ABOUT 77MM FROM THE RIGHT RENAL ARTERY. THE PHYSICIANS PARTIALLY DEPLOYED THE ALTO MAIN BODY STENT GRAFT ABOVE THE LANDING ZONE, ADVANCED A WIRE INTO THE CONTRALATERAL LIMB LUMEN, THEN SNARED AND EXTERNALIZED THE WIRE INTO THE CONTRALATERAL ACCESS. THE DEVICE SUCCESSFULLY LANDED AT THE DESIRED LOCATION. THE IPSILATERAL LIMB AND THE RINGS FILLED (WITH POLYMER), BUT THE CONTRALATERAL LIMB DIDN¿T. THE CASE CONTINUED BY EXTENDING INTO THE COMMON ILIACS JUST SHORT OF THE HYPOGASTRIC ARTERIES ON BOTH SIDES WITH THE OVATION IX ILIAC STENT GRAFT LIMBS. DURING THE DEPLOYMENT OF THE CONTRALATERAL LIMB, IT LANDED BELOW THE THIRD HALF RING IN THE ALTO MAIN BODY LIMB. AFTER BALLOONING THE LIMBS AN ANGIOGRAPHY WAS OBTAINED THAT SHOWED A TYPE IA ENDOLEAK AND A RUPTURED RIGHT COMMON ILIAC ARTERY AROUND THE
Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture; Shock
MAUDE report 24434605 ↗InjuryFeb 24, 2026Fluid/Blood Leak
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. EIGHT MINUTES INTO THE INITIAL PROCEDURE THE PATIENT BECAME UNSTABLE AND BLOOD PRESSURE DROPPED. THE POLYMER RINGS LOST THEIR CONTRAST, THE AUTO INJECTOR WAS REMOVED AND ANESTHESIA WAS INFORMED. ANESTHESIA INTUBATED THE PATIENT, GOT BLOOD PRESSURE UNDER CONTROL AND PLACED PATIENT ON A VENTILATOR. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT (NON-ENDOLOGIX)TO STABILIZE THE SEALING RINGS OF THE ALTO MAIN BODY. THE ANEURYSM WAS EXCLUDED AND POST COMPUTED TOMOGRAPHY ANGIOGRAPHY TAKEN ONE HOUR LATER LOOKED GOOD. THE PATENT WAS THEN SENT TO THE INTENSIVE CARE UNIT. THE FOLLOWING DAY THE PATIENT WAS EXTUBATED, RESPONDING TO COMMANDS, AND MOVING ARMS AND LEGS. THE PATIENT IS IN A REHAB FACILITY OUT OF THE HOSPITAL AND HAS HAD A LOT OF BLOOD TRANSFUSIONS DUE TO A HEMATOMA NOT RELATED TO THE PROCEDURE. PATIENT SORES ON BACK ARE CLEARING UP.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24433857 ↗InjuryFeb 10, 2026Malposition of Device; Lack of Effect
THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AFTER THE STENT-GRAFT WAS DEPLOYED, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN FELT THERE WERE VERY LIMITED OPTIONS FOR REPAIRING INTRAOPERATIVELY TYPE 1A ENDOLEAK DUE TO LENGTH FROM RENAL TO TOP OF LIMBS BEING LESS THAN 45MM, AND PHYSICIAN DID NOT WANT TO PALMAZ DUE TO OTHER SURGICAL AND ENDO OPTIONS. THE PATIENT IS BEING MONITORED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE INTRAOPERATIVE TYPE IA ENDOLEAK HAS NOT BEEN RESOLVED AND IT IS UNKNOWN IF FURTHER INTERVENTION WILL BE PERFORMED. THE PATIENT IS CURRENTLY DOING FINE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3008011247-2021-00081. ADDITIONAL INFORMATION: IT WAS REPORTED THAT CURRENTLY THE STENT GRAFT WAS FOUND TO HAVE SETTLED INTO THE REVERSE TAPER NECK COMING DOWN LOWER THAN INTENDED AND THE STENT GRAFT RADIO OPAQUE MARKERS ARE SITTING 5-7MM BELOW THE RENAL WITH THE CENTER OF THE RING SITTING AT 15MM BELOW THE RENAL WHERE THE NECK IS 39MM IN DIAMETER. THE ENDOLEAK APPEARS TO BE ALL ANTERIOR ON CENTERLINE. IT WAS NOTED THAT COILING AROUND THE RING COULD BE ATTEMPTED IF AN OPEN REPAIR IS NOT A FEASIBLE OPT
Patient problems: Aneurysm
MAUDE report 24308889 ↗
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.
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