Alto™ Abdominal Stent Graft System TV-AB2680-N (UDI M701TVAB2680N1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVAB2680N1), received between Nov 3, 2020 and Nov 8, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 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). APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP A TYPE 1A ENDOLEAK WAS IDENTIFIED AS WELL AS AN ANEURYSM ENLARGEMENT OF 2CM. THE PHYSICIAN IS CURRENTLY ASSESSING THE POSSIBILITY OF A RE-INTERVENTION.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18097617 ↗
• InjuryOct 4, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2020. AFTER THE ALTO MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS WERE IMPLANTED, THERE WAS AN INTRAOPERATIVE TYPE IA ENDOLEAK. THE TYPE IA ENDOLEAK WAS SEALED WITH THE IMPLANT OF A NON-ENDOLOGIX PALMAZ STET GRAFT. ON AN UNKNOWN DATE IN 2022, PERCUTANEOUS COILING OF AN ENDOLEAK WAS PERFORMED. PATIENT STATUS WAS NOT REPORTED TO ENDOLOGIX.

  Patient problems: Clinical Endoleak

  MAUDE report 17872944 ↗
• InjurySep 28, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS BEING IMPLANTED WITH AN ALTO ABDOMINAL STENT GRAFT SYSTEM. DURING THE PROCEDURE, IT WAS REPORTED THAT AN INTRAOPERATIVE 1A ENDOLEAK WAS IDENTIFIED. THE INTRAOPERATIVE 1A ENDOLEAK STILL REMAINS. THE PHYSICIAN ELECTED TO COMPLETE THE CASE AND WILL MONITOR THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12540749 ↗
• InjurySep 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (2) TWO MONTHS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW-UP, A TYPE 2 ENDOLEAK (NON ¿ DEVICE-RELATED FAILURE) AND A POSSIBLE TYPE 1A ENDOLEAK WERE IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: THE PHYSICIAN DOES NOT FEEL THERE IS A TYPE 1A ENDOLEAK. THE PHYSICIAN CONFIRMED THERE WAS A (NON-DEVICE-RELATED) TYPE 2 ENDOLEAK. THEREFORE, A COMPLAINT IS NO LONGER WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12434157 ↗
• InjuryJun 21, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A TYPE 1A ENDOLEAK. THE PATIENT WILL BE TAKEN OFF MEDICATION AND IS CURRENTLY BEING MONITORED. CLARIFICATION: THE PATIENT WAS PREVIOUSLY ON MEDICATION PLAVIX (INHIBITS PLATELET AGGREGATION AND THUS INHIBITS ASPECTS OF BLOOD CLOTTING).

  Patient problems: Failure of Implant

  MAUDE report 12037868 ↗
• InjuryFeb 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AN OVATION ALTO ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED. THE PATIENT EXPERIENCED HYPOTENSION EVIDENCED BY A DROP IN BLOOD PRESSURE, AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE CONCLUSION OF THE IMPLANT PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND WITHOUT SYMPTOMS.

  Patient problems: Failure of Implant; High Blood Pressure/ Hypertension

  MAUDE report 11334924 ↗
• InjuryDec 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION ALTO ABDOMINAL AORTIC ANEURYSM STENT. FOURTEEN (14) DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH BILATERAL RENAL STENOSIS WHICH THE PHYSICIAN BELIEVES IS DUE TO THE SUPRARENAL PORTION OF THE STENT. THE PATIENT IS CURRENTLY STABLE AND NO RE-INTERVENTION IS PLANNED AT THIS TIME. ADDITIONAL INFORMATION: THE RENAL STENOSIS EVENT/INCIDENT WAS REFUTED. THERE WAS ADEQUATE RENAL FLOW POST (EVAR) ENDOVASCULAR ANEURYSM REPAIR. THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE II ENDOLEAK OF THE LUMBAR ARTERY OCCURRED. AS A TYPE II ENDOLEAK IS ANATOMY-RELATED AND IS NOT DEVICE RELATED. THIS EVENT IS NO LONGER REPORTABLE TO THE FDA AS THERE IS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF AN ENDOLOGIX DEVICE. A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Stenosis

  MAUDE report 11033151 ↗
• InjuryNov 3, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE WEEKS POST INITIAL PROCEDURE THE PHYSICIAN REPORTED THAT THE PATIENT HAD SOME RIGHT LEG DISCOMFORT. A COMMUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED THAT THE RIGHT LIMB OF THE ALTO AORTIC BODY MAY BE KINKED DUE TO ANGLE OF THE AORTA. THE PHYSICIAN ELECTED TO ADD A BALLOON EXPANDABLE STENT TO RIGHT LIMB OF AORTIC BODY. PATIENT IS STILL EXHIBITING DIMINISHED TO NO PULSES. THE PHYSICIAN HAS NO PLANS TO RE-INTERVENE THE PATIENT IS HOME AND DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 10782650 ↗

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