Alto™ Abdominal Stent Graft System TV-AB2980-N (UDI M701TVAB2980N1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M701TVAB2980N1), received between Feb 3, 2021 and Nov 10, 2022 — classified as 2 deaths, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2022Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; 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). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE A POSSIBLE TYPE 3B ENDOLEAK AND SAC GROWTH WERE NOTED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak; Failure of Implant

  MAUDE report 15775512 ↗
• InjuryAug 10, 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). DURING THIS INITIAL PROCEDURE, THERE WAS A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A NON ENDOLOGIX (PALMAZ) STENT. THE ENDOLEAK IMPROVED BUT IT DID NOT COMPLETELY RESOLVE. THE PATIENT IS CURRENTLY BEING MONITORED AND THE ENDOLEAK WILL BE RE-EVALUATED AT THE 30 DAY FOLLOW UP VISIT. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE TYPE IA ENDOLEAK HAS RESOLVED ON ITS OWN AND REINTERVENTION WAS NOT REQUIRED.

  Patient problems: Failure of Implant

  MAUDE report 12305342 ↗
• InjuryJul 2, 2021Positioning Failure; Positioning Failure

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT WHEN THE POLYMER WAS DELIVERED, THE CONTRALATERAL LIMB DID NOT DEPLOY. ALL TROUBLESHOOTING STEPS WERE PERFORMED; HOWEVER, THE CONTRALATERAL LIMB DID NOT DEPLOY SO THE POLYMER WAS NOT ABLE TO FILL THE LIMB. DEPLOYMENT OF THE IPSILATERAL LIMB WAS COMPLETED AND THE ANEURYSM WAS SEALED WITHOUT AN ENDOLEAK. THE PHYSICIAN THEN PERFORMED A FEMORAL-FEMORAL BYPASS TO PROVIDE BLOOD FLOW TO BOTH LOWER EXTREMITIES. THE PATIENT WAS REPORTED AS DOING WELL AND BOTH LOWER EXTREMITIES HAVE PALPABLE PULSES.

  Patient problems: Failure of Implant

  MAUDE report 12110984 ↗
• InjuryJun 15, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE PATIENT PRESENTED WITH A SHORT ANGLED AORTIC NECK THAT WAS FUNNEL IN SHAPE. IT WAS REPORTED THAT WHEN THE PROXIMAL FIXATION OPENED THE PHYSICIAN PUSHED UP ON THE DELIVERY SYSTEM TO BALLOON THE RING; HOWEVER, THE RINGS PUSHED UP, COVERED THE RIGHT RENAL ARTERY AND PARTIALLY COVERED THE LEFT. THE PHYSICIAN WAS ABLE TO STENT THE LEFT RENAL BUT THE GRAFT SLIPPED INTO THE RENAL ARTERY MORE THAN PLANNED. THE PHYSICIAN WAS UNABLE TO ADVANCE A SECOND RENAL STENT. THE PATIENT IS STABLE AND PRODUCING URINE WHEN HE LEFT THE OPERATING ROOM AND CURRENTLY BEING MONITORED WHILE ADDITIONAL INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 12005738 ↗
• InjuryJun 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY BEING IMPLANTED WITH AN ALTO ABDOMINAL STENT GRAFT SYSTEM. DURING THE PROCEDURE, THE INTEGRATED BALLOON RUPTURED UPON INFLATION. THE ILIAC LIMBS WERE SUCCESSFULLY DEPLOYED USING THE UP AND OVER LUMEN AND, A PALMAZ P4010 (NON-ENDOLOGIX DEVICE) WAS PLACED AT THE LEVEL OF THE SEALING RING. A TYPE 1A ENDOLEAK WAS IDENTIFIED SO THE PHYSICIAN CHOSE TO STOP THE PROCEDURE. THE PHYSICIAN WILL BE GETTING A (CT) COMPUTED TOMOGRAPHY SCAN TO ASSESS THE LEAK LOCATION AND OPTIONS.

  Patient problems: Failure of Implant

  MAUDE report 11935306 ↗
• DeathFeb 17, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AN INTRAOPERATIVE TYPE 1A ENDOLEAK WAS OBSERVED. THE PHYSICIAN ATTEMPTED BALLOONING AND IMPLANTED A NON-ENDOLOGIX (PALMAZ) BARE METAL STENT. THE NON-ENDOLOGIX (PALMAZ) BARE METAL STENT WAS MOUNTED ON A TYSHAK (NON - ENDOLOGIX) BALLOON. THE BALLOON WAS OVERINFLATED AND DISSECTED THE AORTA ABOVE THE RENAL ARTERIES. THE INTRAOPERATIVE TYPE 1A ENDOLEAK WAS RESOLVED. TWO (2) NON-ENDOLOGIX (COOK) ENDOGRAFTS WERE IMPLANTED TO CORRECT THE DISSECTION OF THE AORTA AND A RUPTURE THE RUPTURE APPEARED TO BE CONTAINED AND THE PATIENT¿S ACCESS SITES WERE CLOSED. THE PROCEDURE HAS CONCLUDED HOWEVER, IT WAS LATER REPORTED THAT THE PATIENT EXPIRED LATER THAT DAY. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Death; Rupture

  MAUDE report 11340864 ↗
• DeathFeb 3, 2021Use of Device Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Patient-Device Incompatibility; Insufficient Device Problem Information

  DURING THE INITIAL IMPLANT OF THE OVATION ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA), THE PHYSICIAN WAS UNABLE TO CANNULATE THE CONTRALATERAL LIMB. AFTER SEVERAL HOURS OF TRYING MULTIPLE TECHNIQUES THE PHYSICIAN OPTED TO ABORT THE PROCEDURE. ONLY THE AORTIC MAIN BODY AND ONE (1) LIMB WAS IMPLANTED. AN INTERVENTION IS BEING PLANNED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 11273086 ↗

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