Alto™ Abdominal Stent Graft System TV-AB2380-N (UDI M701TVAB2380N1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M701TVAB2380N1), received between Oct 5, 2020 and Apr 16, 2021 — classified as 1 death, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE MONTHS POST INITIAL PROCEDURE DURING ROUTINE FOLLOW UP, AN ULTRASOUND REVEALED SAC GROWTH. AN ANGIOGRAM WAS PERFORMED AND REVEALED A PSEUDO ANEURYSM ABOVE THE RENAL ARTERIES THAT CONTINUED BELOW THE RINGS OF THE ALTO DEVICE. THE PSEUDO ANEURYSM DID COMMUNICATE WITH THE PRIMARY FUSIFORM ANEURYSM, HOWEVER IT IS NOT CATEGORIZED AS A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THIS EVENT BY PLACING A NUMBER OF PNUMBRA (NON-ENDOLOGIX) COILS. THE PATIENT IS CURRENTLY BEING MONITORED TO CONFIRM THE EVENT HAS BEEN RESOLVED.

  Patient problems: Aneurysm; Pseudoaneurysm

  MAUDE report 11682740 ↗
• InjuryJan 28, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (4) WEEKS POST INITIAL IMPLANT THE PATIENT PRESENTED FOR A ROUTINE VISIT AND A TYPE 1A ENDOLEAK WAS IDENTIFIED. AN INTERVENTION IS BEING PLANNED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 11245628 ↗
• DeathDec 3, 2020Material Puncture/Hole; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Device-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH THE OVATION ALTO ABDOMINAL STENT GRAFT SYSTEM AND THREE (3) OVATION IX ILIAC LIMBS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT SHOULD BE NOTED THAT THERE WAS A PREVIOUSLY PLACED GORE (NON-ENDOLOGIX) LIMB IN THE RIGHT COMMON COVERING THE COILED HYPO AND EXTENDING INTO THE EXTERNAL. FINAL ANGIOGRAPHY IDENTIFIED AN INTRAOPERATIVE TYPE 1B ENDOLEAK ON THE RIGHT. THIS WAS EXTENDED WITH A VIABHON (NON-ENDOLOGIX) STENT. SUBSEQUENT ANGIOGRAPHY SHOWED A BLUSH, POSSIBLE INTRAOPERATIVE TYPE IIIA ENDOLEAK, IN ILIAC LIMB. THIS WAS RESOLVED WITH IMPLANT OF AN OVATION IX ILIAC LIMB. DURING ADVANCEMENT OF A 12X4 BALLOON IN THE LEFT COMMON ILIAC, THE ILIAC LIMB THAT WAS IN THE EXTERNAL ON THE LEFT (COILED HYPO AND EXTENDED INTO EXTERNAL ON THE LEFT) WAS PUSHED UP BY THE SHEATH AND INTO THE COMMON AS THE SHEATH ON THE LEFT HAD RETRACTED BACK PUSHED INTO THE ARTERY AND CATCHING THE BOTTOM OF LIMB GRAFT IN THE LEFT COMMON THIS WAS BALLOONED, SEAL WAS RE-ATTAINED. THE FINAL ANGIOGRAPHY SHOWED A NEW INTRAOPERATIVE TYPE 1A ENDOLEAK. PERFORMED BALLOONING WITH A 20MM ZMED SUBSEQUENT ANGIOGRAPHY SHOWED THE LEAK WAS STILL FAINT. AN ADDITIONAL PALMAZ (NON-ENDOLOGIX) STENT WAS

  Patient problems: Death; Failure of Implant; Heart Failure; Rupture

  MAUDE report 10942430 ↗
• InjuryOct 5, 2020Failure to Advance; Difficult to Advance; Insufficient Device Problem Information; Failure to Advance; Difficult to Advance; Insufficient Device Problem Information

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN OVATION ALTO ABDOMINAL STENT GRAFT AND TWO OVATION IX ILIAC LIMBS. POST DEPLOYMENT AND POLYMER FILL AN INTRAOPERATIVE TYPE 1A ENDOLEAK WAS IDENTIFIED. AN ATTEMPT WAS MADE TO BALLOON THE TYPE 1A ENDOLEAK; HOWEVER, THE INTEGRAL BALLOON OF THE OVATION ALTO DELIVERY SYSTEM WOULD NOT ADVANCE PAST THE SIGNIFICANT ANGLE AT THE GRAFT BIFURCATION. PATIENT IS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10627665 ↗

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