Alto™ Abdominal Stent Graft System TV-AB3480-N (UDI M701TVAB3480N1)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M701TVAB3480N1), received between Dec 7, 2020 and Oct 16, 2024 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryOct 16, 2024Improper or Incorrect Procedure or Method; Lack of Effect; Improper or Incorrect Procedure or Method; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2020 WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM AND A PALMAZ (NON-ENDOLOGIX) STENT WAS IMPLANTED AT INITIAL IMPLANT DUE TO A POSSIBLE TYPE IA ENDOLEAK. THE ENDOLEAK WAS REPORTED TO BE NOT VISIBLE AT THE END OF THE PROCEDURE. THE PATIENT STATUS WAS NOT REPORTED AT THE TIME. ON (B)(6) 2023 THE PATIENT WAS TREATED FOR A TYPE II ENDOLEAK WITH LASER FENESTRATION THROUGH THE LIMB AND EMBOLIZATION COILS. ADDITIONALLY, THE LEFT LIMB WAS RELINED WITH AN OVATION IX ILIAC LIMB POST COILING TO COVER THE FENESTRATION. THE PATIENT STATUS WAS NOT REPORTED AT THE TIME. THE PATIENT SUBSEQUENTLY HAD THEIR LUMBAR ARTERIES AND POSTERIOR ANEURYSM SAC COIL EMBOLIZED IN (B)(6) OF 2023. THE PATIENT STATUS WAS NOT REPORTED AT THE TIME. THE PATIENT PRESENTED TO (B)(6) MEDICAL CENTER ON (B)(6) 2024 WITH BELLY TENDERNESS. THE PATIENT¿S VITALS WERE STABLE WITH NO HEMODYNAMIC ISSUE. AN OUTSIDE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED CONTRAST PASSING AROUND THE PROXIMAL RING WITH NO SAC FILLING IN EITHER ARTERIAL OR DELAYED PHASE. THERE WAS NO RUPTURE AND NO STRIATING IN THE ABDOMEN. THERE WAS A TYPE IA ENDOLEAK. THE PATIENT WAS

  Patient problems: Abdominal Pain; Aneurysm; Clinical Endoleak; Hematoma; Vascular Dissection

  MAUDE report 20463793 ↗
• InjuryJul 9, 2024Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021. A RECENT FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED AN UNKNOWN ENDOLEAK, EITHER A TYPE IIIB ENDOLEAK OR A TYPE II ENDOLEAK. IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY TREATED FOR A TYPE II ENDOLEAK ON TWO SEPARATE OCCASIONS, ONE WAS A DIRECT STICK OF ANEURYSM SAC AND THE OTHER WAS CATHETER BASED TREATMENT ON UNKNOWN DATES. THE PATIENT RETURNED FOR INTERVENTION AND A TYPE IIIB ENDOLEAK WAS FOUND ON CONTRAST ENHANCED ULTRASOUND, HOWEVER IT WAS REPORTED THAT THIS MAY HAVE BEEN CAUSED BY THE DIRECT STICKING OF THE ANEURYSM SAC WHEN THE PHYSICIAN WAS TREATING THE PREVIOUSLY DETECTED TYPE II ENDOLEAK ON AN UNKNOWN DATE. THE PHYSICIAN IMPLANTED TWO OVATION IX ILIAC LIMBS AND THE TYPE IIIB ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19707174 ↗
• InjuryNov 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM ON (B)(6) 2021. DURING THE INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. A PALMAZ STENT (NON-ENDOLOGIX) WAS IMPLANTED TO ATTEMPT TO SEAL THE TYPE IA ENDOLEAK; HOWEVER, THIS WAS NOT SUCCESSFUL. IT SHOULD BE NOTED THAT THE NECK WAS OFF LABEL AS IT WAS SHORT AND A SEVERELY ANGULATED PARARENAL AAA. THE NECK LENGTH WAS 3MM AND SHOULD BE GREATER THAN 7MM. THE TAPER WAS 31.4% SHOULD BE LESS THAN 10%. THE PATIENT WAS MONITORED AND THE 30-DAY COMPUTERIZED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED NO TYPE IA ENDOLEAK. THERE WAS SOME CONTRAST IN THE DISTAL AORTA THAT WAS IDENTIFIED TO BE A TYPE II ENDOLEAK (NON-DEVICE RELATED). THOUGH THE INTRAOPERATIVE TYPE IA ENDOLEAK SEALED ITSELF AT 30 DAYS, IT WAS REPORTED UNDER MFR# 3008011247-2021-00116. ON (B)(6) 2023, THE CTA IDENTIFIED A POSSIBLE TYPE IA AND A TYPE II ENDOLEAK. THE PATIENT IS REPORTED TO BE STABLE AND IS BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 18132583 ↗
• InjurySep 28, 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 THE INITIAL IMPLANT PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT (NON-ENDOLOGIX); HOWEVER, THE TYPE IA ENDOLEAK DID NOT RESOLVE. THE PATIENT WILL BE MONITORED AND A 30-DAY COMPUTERIZED TOMOGRAPHY WILL BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 12544135 ↗
• DeathSep 7, 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 A PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE CASE WAS DONE EMERGENTLY TO TREAT THE RUPTURED AAA; HOWEVER, THE PATIENT EXPIRED ONE DAY AFTER THE PROCEDURE DUE TO A MYOCARDIAL INFARCTION (MI).

  Patient problems: Myocardial Infarction

  MAUDE report 12436472 ↗
• InjuryAug 17, 2021Filling Problem; Filling Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THERE WAS A PARTIAL FILL OF THE ALTO GRAFT AND AN INTRAOPERATIVE TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT, HOWEVER THE ENDOLEAK REMAINED UNRESOLVED. THE PATIENT WILL CONTINUE TO BE MONITORED AT 30-DAY FOLLOW-UP. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE 30-DAY FOLLOW-UP SHOWED THAT THE INTRAOPERATIVE TYPE IA ENDOLEAK HAD RESOLVED AND THAT THE PATIENT IS DOING WELL. THE PHYSICIAN WILL PERFORM A 60-DAY FOLLOW-UP.

  Patient problems: Failure of Implant

  MAUDE report 12331732 ↗
• InjuryJun 19, 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 SEVEN (7) MONTHS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PATIENT IS STABLE AND CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIANS ELECTED TO IMPLANT A PALMAZ BARE METAL STENT (NON- ENDOLOGIX) AND COILS (NON- ENDOLOGIX) TO TREAT THE REPORTED TYPE 1A ENDOLEAK. THE ENDOLEAK APPEARED SIGNIFICANTLY DIMINISHED. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 12029640 ↗
• InjuryDec 7, 2020Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

  THE PATIENT WAS BEING IMPLANTED WITH AN OVATION ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, THE PATIENT HAD PRE-EXISTING BAD RENAL FUNCTION, THE ILIACS WERE EXTREMELY TORTUOUS AND THE AORTIC NECK WAS MODERATELY ANGLED. AFTER PRE-CLOSING THE ILIAC, THE OVATION ALTO WAS INSERTED IN THE RIGHT SIDE FOR USUAL DEPLOYMENT. THE PHYSICIAN (REPORTEDLY, CONTROLLING X-RAY MACHINE AND POSITIONING) PERFORMED SEVERAL ANGIOS TO AGREE UPON CORRECT LANDING SPOT. THE PHYSICIAN THEN ATTEMPTED TO ADJUST THE SHUTTER COLLIMATION TO REDUCE EXPOSURE. IN HINDSIGHT, THE PHYSICIAN MAY HAVE INADVERTENTLY ADJUSTED THE X-RAY MAGNIFICATION. BEFORE THE SECOND NESTED KNOB WAS RELEASED, THE IMAGING WENT LIVE AND IT WAS NOTICED THAT THE MARKERS WERE LOWER THAN A MOMENT BEFORE, THE PHYSICIAN PROCEEDED TO REPOSITION THE MARKS UPWARD TO COMPENSATE FOR THE DROPPAGE. ADDITIONAL ANGIO WAS NOT TAKEN AND DEPLOYMENT CONTINUED AS NORMAL; HOWEVER, THERE WAS DIFFICULTY CANNULATING THE CONTRA-LATERAL GATE, INTEGRATED BALLOONING WAS DONE AT 14 MINUTES ON THE PROXIMAL RINGS. THE UP AND OVER WIRE LUMEN WAS THEN USED TO GET CONTRA-LATERAL GATE ACCESS, AND THE PROCEDURE CONTINUED AS PER USUAL. AFTE

  Patient problems: Failure of Implant; Ischemia

  MAUDE report 10959684 ↗

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