Alto™ Abdominal Stent Graft System TV-AB2980-N (UDI 00850007370909)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00850007370909), received between Jun 10, 2021 and Sep 29, 2026 — classified as 1 death, 56 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (27 reports).

3 other recalls cover devices cleared under the same FDA submission (P120006); they may or may not involve this specific model.

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 65 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Lack of Effect

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 50932563 ↗
• InjuryJan 12, 2026Collapse; Filling Problem; Off-Label Use; Device Dislodged or Dislocated

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. IT WAS REPORTED THAT THE POLYMER FILL DID NOT FILL THE CONTRALATERAL LIMB. ALL TROUBLESHOOTING EFFORTS WERE MADE TO GET THE LIMB TO FILL WITH POLYMER, BUT THEY WERE INEFFECTIVE. THE REST OF THE STENT GRAFT POLYMER FILLED AS USUAL. THE PHYSICIAN USED THE UP AND OVER TECHNIQUE TO OBTAIN CONTRALATERAL ACCESS. ONCE THE CONTRALATERAL ACCESS WAS SECURED, AN 8-40 PERIPHERAL (NON-ENDOLOGIX) BALLOON WAS USED TO ENSURE THE ILIAC LIMB WAS OPEN. AFTER THE POLYMER HAD CURED, THE PHYSICIAN BALLOONED THE MAIN BODY RINGS AND FINISHED WITH THE MAIN BODY. THE OVATION IX IPSILATERAL ILIAC LIMB WAS PLACED, AND THE OVATION IX CONTRALATERAL ILIAC LIMB WAS PLACED AND THEN THE PROXIMAL END OF THE OVATION IX CONTRALATERAL ILIAC LIMB WAS MATCHED WITH THE PROXIMAL END OF THE OVATION IX IPSILATERAL ILIAC LIMB AND IMPLANTED WITHOUT INCIDENT AND THE LIMBS WERE BALLOONED. UPON THE FINAL ANGIOGRAM IT WAS NOTED THAT THE ALTO MAIN BODY HAD SLIPPED DOWN FROM THE ORIGINAL LANDING SPOT, RESULTING IN A TYPE IA ENDOLEAK. BALLOONING WAS ATTEMPTED BUT UNSUCCESSFUL. THE FACILITY HAD NO PALMAZ STENTS

  Patient problems: Clinical Endoleak; Exsanguination

  MAUDE report 24049494 ↗
• InjuryDec 16, 2025Malposition of Device; Malposition of Device

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. THE AORTIC NECK DIAMETER BELOW THE RENAL ARTERIES WAS 20.6MM AND 7MM DISTALLY THE DIAMETER WAS 23.1MM. A (NON-ENDOLOGIX) STENT WAS PLACED IN THE LEFT RENAL ARTERY FOR EXPANSION. THE INFERIOR MESENTERIC ARTERY (IMA) AND THE LUMBAR ARTERY WERE ALSO EMBOLIZED BY PLACING A 36×4.5 GORE (NON-ENDOLOGIX) EXCLUDER. THE ALTO MAIN BODY WAS DEPLOYED TO ALIGN WITH THE INFERIOR EDGE OF THE LOWEST RENAL ARTERY. DURING POLYMER FILLING, DISTAL MIGRATION OF THE MAIN BODY BY APPROXIMATELY 3MM WAS CONFIRMED. AFTER 14 MINUTES, THE INTEGRATED BALLOON WAS USED FOR DILATION. CONTRALATERAL LEG CANNULATION WAS PERFORMED USING THE CROSSOVER LUMEN. AT THIS TIME, FURTHER DISTAL MIGRATION OF THE MAIN BODY BY APPROXIMATELY 2MM WAS OBSERVED AND AN ANGIOGRAM CONFIRMED A TYPE 1A ENDOLEAK. AFTER THE RIGHT AND LEFT ILIAC LIMBS WERE IMPLANTED BALLOON TOUCH-UP ON THE SEALING RING WAS PERFORMED AND A SUBSEQUENT ANGIOGRAM STILL CONFIRMED THE TYPE 1A ENDOLEAK. THE FOLLOWING DEVICES WERE ADDITIONALLY DEPLOYED AT THE SEALING RING, 32×4.5, 28.5×3.3, 36×4.5 GORE (NON-ENDOLOGIX) EXCLUDERS. ADDITIONALLY,

  Patient problems: Clinical Endoleak

  MAUDE report 23816611 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. DURING THE PROCEDURE THE PATIENT¿S AORTA RUPTURED WHILE BALLOONING THE SEALING RINGS. THE PHYSICIAN ELECTED TO PERFORM AN SURGICAL PROCEDURE WITH EXPLANT OF THE STENT GRAFTS AND REPAIR THE RUPTURED AORTA. IT WAS REPORTED THAT THE PATIENT EXPIRED ON 15 OCTOBER 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Rupture

  MAUDE report 23457282 ↗
• InjuryAug 27, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE POLYMER FILL WAS PERFORMED WITHOUT ISSUES, AND THE CONTRALATERAL LIMB WAS PLACED WITHIN 14 MINUTES WITHOUT USING THE CROSSOVER LUMEN. THE IPSILATERAL LIMB WAS ALSO PLACED UNEVENTFULLY. THE FINAL ANGIOGRAM CONFIRMED AN ENDOLEAK AROUND THE INTERFACE BETWEEN THE ALTO MAIN BODY AND THE LEFT LEG. SUSPECTING A POSSIBLE TYPE 1A ENDOLEAK, BALLOON TOUCH-UP OF THE SEALING RING AND SUPPORT RING WAS PERFORMED; HOWEVER, BUT THE SITUATION DID NOT CHANGE. UPON REVIEWING THE INTRAOPERATIVE IMAGING SEVERAL TIMES, A POSSIBLE VASCULAR DISSECTION WAS SUSPECTED; THEREFORE, AN ANGIOGRAM WAS PERFORMED FROM THE PROXIMAL CROWN SECTION AND DID NOT CONFIRM A DISSECTION CAVITY. BY A PROCESS OF ELIMINATION, A TYPE 3B WAS SUSPECTED; THEREFORE, AN ANGIOGRAM WAS PERFORMED FROM THE MAIN BODY SECTION AND IMMEDIATELY AFTER CONTRAST WAS INJECTED, AN ENDOLEAK FROM THE MAIN BODY WAS CONFIRMED, RESULTING IN THE DETERMINATION OF A TYPE 3B ENDOLEAK. SINCE THE ENDOLEAK WAS NOT FLOWING INTO THE ANEURYSM, THE PROCEDURE WAS COMPLETED EXPECTING THE ENDOLEAK WILL THROMBOSE. THE PATIENT IS BEING MONITO

  Patient problems: Clinical Endoleak

  MAUDE report 22904577 ↗
• InjuryAug 19, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE FINAL POST IMPLANT IMAGE SHOWED A TYPE 1A ENDOLEAK AND WHEN BALLOONING WAS PERFORMED THE ENDOLEAK APPEARED WORSE. THE PHYSICIAN TOOK A SHOT WITH A PIGTAIL CATHETER FROM WITHIN THE ALTO MAIN BODY AND FOUND THE GRAFT WAS INTACT. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND TO REEVALUATE THE CONDITION OF THE ENDOLEAK IN A FEW WEEKS THE PATIENT WAS REPORTED AND DOING GREAT.

  Patient problems: Clinical Endoleak

  MAUDE report 22843911 ↗
• InjuryJul 9, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  CONFIRMATION WAS RECEIVED ON 03 SEPTEMBER 2025, THAT THE FOLLOW-UP COMPUTED TOMOGRAPHY HAS NOT YET BEEN PERFORMED.

  Patient problems: Clinical Endoleak

  MAUDE report 22456784 ↗
• InjuryJun 25, 2025Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. THE ALTO MAIN BODY WAS DELIVERED VIA THE LEFT ACCESS, BUT DURING POLYMER INJECTION, INCOMPLETE FILL OCCURRED DUE TO A KINKED POLYMER PATH TO THE CONTRALATERAL LEG. THE PHYSICIAN REPOSITIONED AND MANIPULATED, BUT FULL FILL COULD NOT BE ACHIEVED. CANNULATION ATTEMPTS VIA THE CROSSOVER LUMEN WERE INITIALLY UNSUCCESSFUL BUT EVENTUALLY SUCCEEDED AFTER INFLATING THE INTEGRATED BALLOON, ALLOWING ACCESS PAST THE OBSTRUCTION. BOTH CONTRALATERAL AND IPSILATERAL OVATION IX LIMBS WERE IMPLANTED SUCCESSFULLY. FINAL ANGIOGRAPHY SHOWED NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330110 ↗
• InjuryMay 21, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO STENT GRAFT SYSTEM ON (B)(6) 2022. THE ALTO MAIN BODY WAS USED AS AN AORTO-UNI-ILIAC (AUI) DEVICE, SECURING THE CONTRALATERAL LIMB WITH SUTURES AFTER FAILING TO CROSS THE RIGHT COMMON ILIAC ARTERY. APPROXIMATELY TWO (2) YEARS POST INDEX PROCEDURE FOLLOW-UP IDENTIFIED A TYPE IB ENDOLEAK. THE TYPE IB ENDOLEAK ORIGINATED FROM THE TIED-OFF LIMB. REINTERVENTION WAS PERFORMED ON (B)(6) 2025. A TAPERED AFX LIMB STENT GRAFT WAS IMPLANTED TO SEAL THE AFFECTED LIMB AND EXTENDED PROXIMALLY USING AN OVATION IX EXTENDER. THE TYPE IB ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS DISCHARGED.

  Patient problems: Clinical Endoleak

  MAUDE report 22063072 ↗
• InjuryMar 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN ALTO STENT GRAFT SYSTEM ON (B)(6) 2022. THE ALTO MAIN BODY WAS USED AS AN AORTO-UNI-ILIAC (AUI) DEVICE, SECURING THE CONTRALATERAL LIMB WITH SUTURES AFTER FAILING TO CROSS THE RIGHT COMMON ILIAC ARTERY. APPROXIMATELY TWO (2) YEARS POST INDEX PROCEDURE FOLLOW-UP IDENTIFIED A TYPE IB ENDOLEAK. THE TYPE IB ENDOLEAK ORIGINATED FROM THE TIED-OFF LIMB. REINTERVENTION WAS PERFORMED ON (B)(6) 2025. A TAPERED AFX LIMB STENT GRAFT WAS IMPLANTED TO SEAL THE AFFECTED LIMB AND EXTENDED PROXIMALLY USING AN OVATION IX EXTENDER. THE TYPE IB ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT WAS DISCHARGED.

  Patient problems: Clinical Endoleak

  MAUDE report 21688057 ↗
• InjuryJan 27, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. APPROXIMATELY THREE (3) MONTHS AFTER THE INDEX PROCEDURE, DURING FOLLOW-UP, THE PATIENT EXHIBITED SIGNS OF A POTENTIAL TYPE IA ENDOLEAK. ON (B)(6), 2025, THE PATIENT UNDERWENT A RE-INTERVENTION DURING WHICH THE PHYSICIAN ELECTED TO IMPLANT A (NON-ENDOLOGIX) PALMAZ P3110 ON AN ATLAS 18X4. IT WAS REPORTED THAT THE TYPE IA ENDOLEAK WAS RESOLVED. THE PATIENT¿S FINAL STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 21243180 ↗
• MalfunctionNov 14, 2024Filling Problem; Malposition of Device; Filling Problem; Malposition of Device

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2023, INVOLVING THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS INSERTED WITHOUT VERIFYING CONTRALATERAL ORIENTATION, RESULTING IN MISALIGNMENT OF THE MARKER POSITION. TO ADDRESS THIS, THE ENTIRE SHEATH WAS ROTATED. FOLLOWING MAIN BODY DEPLOYMENT, A SLOW POLYMER INJECTION CAUSED THE CONTRALATERAL LEG TO DEPLOY ON THE UNINTENDED RIGHT SIDE INSTEAD OF THE PLANNED LEFT. ALTHOUGH POLYMER WAS NOT INJECTED INTO THE CONTRALATERAL LEG, THE RIM WAS PLACED AS INTENDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686538 ↗
• InjuryAug 22, 2024Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. DURING THE PROCEDURE, ISSUES AROSE WITH THE POLYMER INJECTION USING THE AUTO-INJECTOR. INITIALLY, ONLY THE IPSILATERAL LIMB RINGS WERE FILLED. ATTEMPTS TO RESOLVE THIS BY EXCHANGING THE AUTO-INJECTOR AND ADJUSTING THE DEVICE POSITION FAILED. ABOUT FIVE (5) MINUTES AFTER THE INITIAL POLYMER INJECTION, THE PHYSICIAN MANUALLY PUSHED THE SYRINGE WITH SIGNIFICANT FORCE, SLIGHTLY FILLING THE SEALING RING, BUT THE POLYMER STARTED TO CURE. FURTHER ATTEMPTS TO PUSH THE SYRINGE MANUALLY WERE UNSUCCESSFUL AS THE POLYMER HAD ALREADY CURED INSIDE. A SECOND POLYMER FROM THE SAME LOT WAS USED, BUT THE ALREADY CURED POLYMER INSIDE THE DELIVERY SYSTEM BLOCKED THE NEW INJECTION. THE SECOND POLYMER WAS ALSO CURED, WITHIN FIVE (5) MINUTES. A BALLOON TOUCH-UP WAS PERFORMED FOURTEEN (14) MINUTES AFTER THE FIRST INJECTION. ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. THE CONTRALATERAL GATE WAS ACCESSED THROUGH THE CROSS-OVER LUMEN, AND BOTH CONTRALATERAL AND IPSILATERAL LIMBS WERE IMPLANTED. A (NON-ENDOLOGIX) EXCLUDER CUFF WAS IMPLANTED PROXIMALLY. A TYPE II ENDOLEAK

  Patient problems: Clinical Endoleak

  MAUDE report 20032724 ↗
• InjuryJul 16, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT A 5.2 CM SACCULAR ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN IRREGULAR THROMBUS APPEARANCE ON JUNE 25, 2024. AN INITIAL COMPUTED TOMOGRAPHY (CT) SCAN SHOWED TWO LEFT RENAL ARTERIES, AND IT WAS PLANNED TO USE A 26 MM AORTIC BODY (AB) TO SEAL AND MAINTAIN A PATENT LOWER RENAL ARTERY. UPON FURTHER EVALUATION OF THE CT SCAN IT WAS DETERMINED THAT THE PATIENT HAD THREE LEFT RENAL ARTERIES AND ONE RIGHT RENAL ARTERY. THE INFERIOR MESENTERIC ARTERY (IMA) WAS LARGE AND PATENT, WITH A PAIR OF LARGE LUMBAR ARTERIES ADJACENT. THE PATIENT UNDERWENT A PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR (PEVAR) WITH THE IMPLANTATION OF THE ALTO MAIN BODY. TO PREVENT A TYPE 2 ENDOLEAK, THE IMA WAS COIL EMBOLIZED BEFORE GRAFT INSERTION, WHICH WAS SUCCESSFULLY PERFORMED WITHOUT COMPLICATIONS. THE ALTO GRAFT WAS INITIALLY PLACED AT THE SECOND LEFT RENAL ARTERY, AIMING TO PRESERVE THE THIRD LEFT RENAL ARTERY. A 29 MM ALTO AB WAS UTILIZED INSTEAD OF THE PLANNED 26 MM AB. IT WAS RECOGNIZED THAT THE THIRD INFERIOR LEFT RENAL ARTERY MIGHT NEED TO BE SACRIFICED TO ENSURE AN ADEQUATE PROXIMAL NECK LANDING ZONE. THE GRAFT WAS SUCCESSFULLY DEPLOYED, BUT

  Patient problems: Clinical Endoleak; Embolism/Embolus; Ischemia; Paraplegia

  MAUDE report 19757015 ↗
• InjuryJul 1, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM ON (B)(6) 2022. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL DUE TO SHOULDER ARTHRITIS, KNEE ARTHRITIS AND LUMBAR PAIN. THE PATIENTS CONDITION DID NOT IMPROVE IN FIVE (5) DAYS AND WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE COMPUTED TOMOGRAPHY (CT) IMAGES SHOWED ANEURYSM ENLARGEMENT, A TYPE II ENDOLEAK, AND POSSIBLE INFLAMMATION AROUND THE STENT GRAFT. THE PHYSICIAN DIAGNOSED THE PATIENT WITH GRAFT INFECTION AND ELECTED TO PERFORM AN OPEN SURGERY TO EXPLANT THE STENT GRAFT AND VESSEL REPLACEMENT. STREPTOCOCCUS WAS DETECTED. PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm; Bacterial Infection; Clinical Endoleak

  MAUDE report 19652150 ↗
• MalfunctionJun 7, 2024Short Fill; Short Fill

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. THE ALTO MAIN BODY WAS DEPLOYED, AND DURING POLYMER FILL, THE CONTRALATERAL LIMB DID NOT FILL. THE PATIENT REQUIRED BILATERAL SURGICAL INCISIONS ON THE FEMORAL ARTERIES DUE TO FAILURES WITH THE PROGLIDE. THE FINAL PATIENT STATUS WAS REPORTED AS ALIVE AND WELL, WITH NO REPORTED ENDOLEAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491483 ↗
• InjuryMay 9, 2024Filling Problem; Patient-Device Incompatibility; Filling Problem; Patient-Device Incompatibility

  THE PATIENT WAS BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE ALTO ABDOMINAL STENT GRAFT DELIVERY SYSTEM WAS INSERTED FROM THE RIGHT ACCESS. DURING POLYMER INJECTION, POLYMER WAS FILLED INTO THE IPSILATERAL RINGS, SEALING RING AND SECONDARY RING, BUT IT STOPPED JUST ABOVE THE 4TH RING OF CONTRALATERAL LIMB (THE MOST PROXIMAL RING OF CONTRALATERAL LIMB). THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE. THE CONTRALATERAL GATE WAS ACHIEVED THROUGH THE CROSS OVER LUMEN. OVATION IX LIMBS WERE IMPLANTED ON BOTH SIDES. THE OPERATION WAS ENDED AFTER BALLOON TOUCH-UP WITHOUT EVIDENCE OF ENDOLEAK. THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19280572 ↗
• InjuryDec 29, 2023Material Invagination; Lack of Effect; Material Invagination; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A TYPE 1A ENDOLEAK WAS PRESENT AT THE END OF THIS PROCEDURE. THE PHYSICIAN BALLOONED INITIALLY AT SIXTEEN (16) MINUTES, AND AFTER THE FINAL RUN, BALLOONED AND HELD FOR TWO (2) MINUTES. THE TYPE 1A ENDOLEAK IMPROVED, BUT THERE WAS STILL A LITTLE BIT OF FILLING. THE PHYSICIAN'S DECISION WAS TO BRING THE PATIENT BACK FOR A 30 DAY COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) BEFORE PROCEEDING. AT THAT POINT, IF THERE IS AN ENDOLEAK, A PALMAZ (NON-ENDOLOGIX) STENT WILL BE PLACED. NO INTERVENTION WAS PERFORMED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 18418849 ↗
• InjuryDec 19, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A TYPE 1A ENDOLEAK WAS PRESENT AT THE END OF THIS PROCEDURE. THE STENT GRAFT WAS BALLOONED BUT DID NOT RESOLVE THE ENDOLEAK. NO INTERVENTION WAS PERFORMED AND THE PATIENT IS BEING MONITORED. PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 18354064 ↗
• MalfunctionDec 14, 2023Filling Problem; Filling Problem

  THE PATENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2023. REPORTEDLY, THE POLYMER FILL WAS EXTREMELY SLOW AND IT WAS AT ABOUT FIVE MINUTES WHEN THE IPSILATERAL LIMB FINALLY STARTED TO SHOW UP (FILL). THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329247 ↗
• InjuryDec 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A TYPE 1A ENDOLEAK WAS PRESENT AT THE END OF THIS PROCEDURE. NO INTERVENTION WAS PERFORMED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 18324118 ↗
• InjuryNov 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A TYPE 1A ENDOLEAK WAS IDENTIFIED DURING THE PROCEDURE. IN AN EFFORT TO ADDRESS THIS COMPLICATION, THE PHYSICIAN OPTED TO UNDERTAKE SUPPLEMENTARY BALLOONING AND DEPLOYED A PALMAZ (NON-ENDOLOGIX) STENT. THE PATIENT WAS LEFT IN STABLE CONDITION WITH THE ENDOLEAK GREATLY REDUCED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 18130543 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY THREE (3) MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK TYPE IB. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) OVATION IX ILIAC LIMB. IT WAS REPORTED THAT THE ENDOLEAK WAS RESOLVED, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Clinical Endoleak

  MAUDE report 17844813 ↗
• InjurySep 15, 2023Off-Label Use; Patient-Device Incompatibility; Lack of Effect; Off-Label Use; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE PATIENT HAD A SEVERELY ANGLED AORTIC NECK. DURING THIS INITIAL PROCEDURE, THERE WAS A TYPE 1A ENDOLEAK. THE PHYSICIAN IMPLANTED A PALMAZ (NON-ENDOLOGIX) STENT IN AN ATTEMPT TO RESOLVE THE ENDOLEAK. THE ENDOLEAK APPEARED TO BE MUCH BETTER; HOWEVER, IT DID NOT COMPLETELY RESOLVE. THE PATIENT WAS REPORTED AS DOING WELL AND WILL CONTINUE TO BE MONITORED WITH A COMPUTED TOMOGRAPHY (CT) AT 30 DAYS POST IMPLANT TO DETERMINE THE STATUS OF THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 17760793 ↗
• MalfunctionSep 7, 2023Inflation Problem; Inflation Problem

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE INTEGRATED BALLOON WOULD NOT INFLATE WHICH CAUSED INCOMPLETE DEPLOYMENT OF MID-CROWN. HOWEVER, THE FINAL RESULT WAS GOOD AND THE PATIENT WAS REPORTED AS DOING WELL. THE DELIVERY SYSTEM WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705359 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P120006. One submission often covers many models, so check the product and lot details in each record.

• Z-2263-2020 · May 6, 2020 · Terminated
  Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
• Z-0125-2015 · Sep 20, 2014 · Terminated
  Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device deliver
• Z-0288-2013 · Oct 19, 2012 · Terminated
  TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The