Alto™ Abdominal Stent Graft System TV-AB2080-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00850007370381), received between Jun 24, 2021 and Jun 9, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Lack of Effect” (5 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 ANEURYSM GROWTH WAS FOUND. THE COMPUTED TOMOGRAPHY (CT) REVEALED A POSSIBLE TYPE IIIB ENDOLEAK BETWEEN THE ALTO MAIN BODY STENT GRAFT AND THE OVATION IX ILIAC LIMB AS WELL AS AN INDETERMINATE ENDOLEAK COMING FROM AROUND THE AORTIC NECK OF THE ALTO MAIN BODY. REINTERVENTION WAS COMPLETED ON (B)(6) 2025. THE PHYSICIAN ELECTED TO IMPLANT (NON-ENDOLOGIX) COVERED STENTS EXTENDING THE PROXIMAL ILIAC LIMBS TO COVER THE ENDOLEAKS. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak; Stenosis; Thrombosis/Thrombus

  MAUDE report 25446033 ↗
• InjuryMay 8, 2026Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. IT WAS REPORTED THAT THE DURING THE PROCEDURE A POLYMER LEAK WAS SUSPECTED. FOLLOWING THE DEPLOYMENT OF THE ALTO BIFURCATED STENT GRAFT VIA A RIGHT APPROACH PER THE STANDARD PROCEDURE, THE POLYMER KIT WAS CONNECTED, AND POLYMER INJECTION WAS PERFORMED. POLYMER WAS INJECTED INTO ALL RINGS; THE IPSILATERAL RING, SEALING RING, SUPPORT RING, CONTRALATERAL RING, AND THE PROCEDURE MOVED TO CONTRALATERAL CANNULATION. DURING THE PROCEDURE, IT WAS CONFIRMED THAT THE FILL SYRINGE CONNECTED TO THE FILL CONNECTOR BOTTOMED OUT ALTHOUGH POLYMER SHOULD HAVE REMAINED IN IT. SUSPECTING A POLYMER LEAK, THE PHYSICIAN CLAMPED THE FILL CONNECTOR TUBE WITH FORCEPS. SIMULTANEOUSLY, THE PATIENT¿S BLOOD PRESSURE DROPPED ACUTELY TO THE 50S. THE ANESTHESIOLOGIST ADMINISTERED NOREPINEPHRINE, AND ALTHOUGH IT TOOK SOME TIME, THE BLOOD PRESSURE RECOVERED TO THE 100S. THE PROCEDURE WAS CONTINUED, AND AFTER 14 MINUTES, TOUCH-UP WAS PERFORMED USING THE INTEGRATED BALLOON. THE CONTRALATERAL LIMB AND THE IPSILATERAL LIMB WERE DEPLOYED, THEN TOUCH-UPS WERE PERFORMED AT THE JUNCT

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25125946 ↗
• InjuryMar 6, 2026Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. DURING THIS INITIAL PROCEDURE, THE ALTO MAIN BODY WAS DEPLOYED VIA THE RIGHT APPROACH. THE POLYMER KIT WAS CONNECTED TO INJECT THE POLYMER. PRIOR TO THE PROCEDURE THE BLOOD PRESSURE WAS 113/50. AFTER COMPLETION OF THE POLYMER FILL, HYPOTENSION WAS OBSERVED WITH A BLOOD PRESSURE OF 40/30 AND THE HEART RATE REMAINED AT APPROXIMATELY 100BPM. ONLY THE BLOOD PRESSURE DECREASED. THE BLOOD PRESSURE NORMALIZED APPROXIMATELY 10-15 MINUTES AFTER TREATMENT BY ANESTHESIA WITH EPHEDRINE HYDROCHLORIDE, NEOSYNEPHRINE, EPINEPHRINE AND POLARAMINE AND THE PROCEDURE WAS CONTINUED. THE BILATERAL LIMBS WERE PLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24539293 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE MAIN BODY WAS PLACED WITHOUT ANY ISSUES, AND POLYMER FILLING WAS COMPLETED. SUBSEQUENTLY, THE CONTRALATERAL LIMB AND THE IPSILATERAL LIMB WERE ALSO IMPLANTED. ANGIOGRAPHY CONFIRMED NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2025 IT WAS DECIDED THAT THE STENT GRAFT WOULD BE REMOVED DUE TO INFECTION. ALTHOUGH THE AAA DECREASED IN SIZE AFTER ALTO IMPLANTATION, AN INFECTION WAS CONFIRMED DUE TO RAOULTELLA SPP. THE PATIENT'S SYMPTOMS DUE TO THE INFECTION ARE UNKNOWN. THE EXPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2025, AND THE BARE PORTION OF THE ALTO WAS CUT. THE ENTIRE GRAFT WAS REMOVED AND REPLACED WITH A Y-SHAPED ARTIFICIAL BLOOD VESSEL. THE PATIENT IS CURRENTLY STILL HOSPITALIZED AND BEING MONITORED.

  Patient problems: Bacterial Infection

  MAUDE report 22345357 ↗
• InjuryMay 21, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR THE ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM. A ROUTINE FOLLOW-UP DIAGNOSTIC ANGIOGRAM PERFORMED ON (B)(6) 2025, IDENTIFIED ANEURYSM ENLARGEMENT AND A POSSIBLE TYPE IA ENDOLEAK. REPORTEDLY, THE PHYSICIAN PLANS TO SCHEDULE AN INTERVENTION TO IMPLANT A PALMAZ (NON-ENDOLOGIX) STENT. THE PATIENT IS STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22062594 ↗
• InjuryJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM, TWO (2) OVATION IX ILIAC LIMBS, AND OVATION PRIME FILL POLYMER. DURING THE INITIAL IMPLANT PROCEDURE, UNIFORM FILLING OF THE GRAFT WAS NOTED. THE PHYSICIAN THEN BEGAN WIRING THE CONTRALATERAL GATE, AND AFTER CANNULATING AND MEASURING THE LENGTH BETWEEN THE CONTRALATERAL GATE AND THE HYPOGASTRIC ARTERY, IT WAS OBSERVED THAT THE PATIENT BECAME HYPOTENSIVE, POSSIBLY DUE TO A SUSPECTED RUPTURE. A CHECK FOR A POLYMER LEAK WAS PERFORMED, INDICATING THAT THE POLYMER SYRINGE WAS EMPTY. THE PHYSICIAN THEN REMOVED THE AUTOINJECTOR SO THAT THE POLYMER SITUATION COULD BE ADDRESSED. EPINEPHRINE AND BENADRYL WERE ADMINISTERED, WHICH STABILIZED THE PATIENT'S VITAL SIGNS. THE PHYSICIAN CHOSE NOT TO INFLATE THE BALLOON NEAR THE SEALING AREA TO AVOID DISRUPT THE POLYMER, AS AN ANGIOGRAM HAD ALREADY CONFIRMED A SECURE SEAL. THE MAIN BODY WAS RELEASED USING A THIRD NESTED KNOB. THE LIMB ON ONE SIDE WAS MEASURED USING IVUS (INTRAVASCULAR ULTRASOUND) AND SUCCESSFULLY IMPLANTED. THE OVATION IX ILIAC LIMBS WERE BALLOONED WITH TWO (2) 12X3 (NON-ENDOLOGIX) BALLOO

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18494564 ↗
• InjuryDec 15, 2023Lack of Effect; Lack of Effect

  THE PATIENT UNDERWENT IMPLANTATION OF THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) DAYS LATER, SUPPLEMENTARY TREATMENT WAS ADMINISTERED TO ADDRESS AN INFECTION CHARACTERIZED BY GAS WITHIN THE AORTA, FEVER, AND SIGNS OF INFLAMMATION. AN OPEN SURGICAL INTERVENTION WAS PERFORMED, INVOLVING DRAINAGE AND OMENTUM FILLING. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE FOLLOWING THE SECONDARY PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 18336649 ↗
• InjuryDec 15, 2023Material Twisted/Bent; Material Twisted/Bent

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE AORTIC BODY WAS IMPLANTED FROM THE RIGHT SIDE AND DEPLOYED WITHOUT PROBLEM. WHEN DEPLOYING THE CONTRALATERAL LEG, IT WAS SLIGHTLY TWISTED, BUT IT WAS RELEASED AFTER BALLOONING. WHEN DEPLOYING THE IPSILATERAL LEG, THE AORTIC BODY WAS NOTED TO BE TWISTED. THERE WAS NO ENDOLEAK OBSERVED AND THE PROCEDURE WAS CONCLUDED. TWO (2) DAYS INITIAL PROCEDURE THE PATIENT'S ANKLE BRACHIAL INDEX (ABI) WAS FOUND TO HAVE DECREASED TO 0.3. AN EMERGENT REINTERVENTION PROCEDURE WAS PERFORMED WHERE SMART (NON-ENDOLOGIX) STENTS WERE IMPLANTED IN THE LEFT AND RIGHT LIMBS OF THE AORTIC BODY RESPECTIVELY AND RELEASED THE TWISTED AORTIC BODY. THE ABI IMPROVED TO 1.0 AND THE PATIENT WAS DISCHARGED FIVE (5) DAYS LATER.

  Patient problems: Stenosis

  MAUDE report 18333937 ↗
• InjuryOct 2, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE POST PROCEDURE ANGIOGRAM REVEALED A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A NON-COMPLIANT (NON-ENDOLOGIX) BALLOON WHICH REDUCED THE ENDOLEAK BUT DID NOT COMPLETELY RESOLVE IT. THE PHYSICIAN WILL FOLLOW UP WITH A COMPUTED TOMOGRAPHY (CT) AT A LATER TIME AND THE PATIENT WAS REPORTED AS DOING GOOD.

  Patient problems: Clinical Endoleak

  MAUDE report 17855316 ↗
• InjuryOct 2, 2023Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE PATIENTS SEVERELY TAPERED NECK. DURING THE INITIAL PROCEDURE A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO WAIT FOR THE 30 DAY FOLLOW UP TO SEE IF THE ENDOLEAK IS STILL PRESENT. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Clinical Endoleak

  MAUDE report 17853301 ↗
• InjuryMay 24, 2023Deformation Due to Compressive Stress; Device Stenosis; Deformation Due to Compressive Stress; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, IT WAS NOTED THAT THE CASE WAS DIFFICULT FROM AN ACCESS STANDPOINT AND AFTER SEVERAL PRE-DILATION AND DOTTERING TECHNIQUES THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. KISSING BALLOON EXPANDABLE (NON-ENDOLOGIX) STENTS WERE USED TO OPEN UP THE NARROW DISTAL AORTA AND WERE PART OF THE PRE CASE PLAN. DURING THE PROCEDURE IT APPEARED AS IF THE LIMBS MIGHT BE TWISTED BUT UPON MOVING THE C-ARM INTO A RIGHT ANTERIOR OBLIQUE (RAO) AND LEFT ANTERIOR OBLIQUE (LAO) POSITION IT APPEARED AS THE LIMBS WERE NOT TWISTED OR COMPROMISED AND DISTAL FLOW WAS GOOD. AT 30 DAY FOLLOW UP, THE COMPUTED TOMOGRAPHY (CT) SHOWED THE FLOW LUMEN IN THE UNSUPPORTED PORTION OF THE MAIN BODY APPEARED TO BE SMALL MEASURING 7MM (AVERAGE FLOW DIAMETER). ADDITIONALLY, THERE APPEARS TO BE A LOT OF CONTRAST COMING OUT OF THE LIMB MID ANEURYSM SAC WHICH WAS SEEN APPROXIMATELY 48MM BELOW THE MAIN BODY FLOW DIVIDER; HOWEVER IT DOES NOT APPEAR TO BE AT THE OVERLAP BETWEEN THE LIMB AND THE MAIN BODY. A TYPE 3A ENDOLEAK SEEMS UNLIKELY. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVEN

  Patient problems: Clinical Endoleak

  MAUDE report 16992493 ↗
• InjuryMay 2, 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 (TWO OVATION IX ILIAC LIMBS WERE IMPLANTED IN THE LEFT ILIAC), ON (B)(6) 2022. ON (B)(6) 2023, A TYPE IIIA ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS IDENTIFIED. REINTERVENTION WAS COMPLETED ON (B)(6) 2023. AT REINTERVENTION THE EXACT ENDOLEAK POINT WAS NOT DETERMINED. A GORE EXCLUDER LEG (NON-ENDOLOGIX) WAS IMPLANTED INTO EACH LIMB. THE TYPE IIIA ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 16856315 ↗
• InjurySep 14, 2022Insufficient 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 SUBSEQUENT POST-BALLOONING ANGIOGRAPHY SHOWED A TYPE 3A ENDOLEAK FROM THE JUNCTION BETWEEN THE AORTIC BODY AND THE RIGHT ILIAC LIMB; THEREFORE ADDITIONAL BALLOONING WAS PERFORMED IN THAT AREA AND THIS SUCCESSFULLY RESOLVED THE TYPE 3A ENDOLEAK, HOWEVER, THE LEFT LEG OF THE ALTO AORTIC BODY APPEARED TO BE NARROWED. ADDITIONAL BALLOONING WAS PERFORMED ON THE LEFT SIDE AND ALTHOUGH THE NARROWING WAS ABLE TO BE EXPANDED WITH THE BALLOON, IT NARROWED AGAIN ONCE THE BALLOON WAS DEFLATED. ALTHOUGH THE NARROWING IN THE LEFT LEG STILL REMAINED, BLOOD FLOW WAS CONFIRMED THROUGH THE NARROWED AREA. A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) WAS ALSO PRESENT AT THE TIME OF THIS PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE DECISION WAS MADE TO MONITOR THE PATIENT. THE PATIENT RETURNED FOR THE ONE MONTH FOLLOW-UP VISIT WITH COMPLAINT OF PAIN AFTER WALKING FOR TWENTY (20) MINUTES. IT WAS NOTED THAT ALTHOUGH THE PULSATION IN THE LEFT LEG WAS PALPABLE, IT WAS WEAKER THAN THAT OF THE RIGHT LEG. THE PATIENT WAS PLACED ON MEDICATION AND IS CURRENTLY BEING MONITORED WHILE A

  Patient problems: Failure of Implant; Pain; Stenosis

  MAUDE report 15419436 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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, A CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A RETROGRADE AORTIC DISSECTION OF THE DESCENDING AORTA. IT WAS REPORTED THAT THE ANCHOR ON THE PROXIMAL CROWN APPEARS TO HAVE CAUSED THIS DISSECTION; HOWEVER, THE PATIENT DID NOT COMPLAIN OF CHEST OR BACK PAIN (DISCOMFORT). THE PATIENT¿S DISCHARGE WAS POSTPONED AND THE PATIENT WILL BE MONITORED IN THE HOSPITAL.

  Patient problems: Vascular Dissection

  MAUDE report 15214782 ↗
• InjuryMay 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM (ONE (1) ALTO MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS). POST-DEPLOYMENT, WHILE ATTEMPTING TO ADVANCE THE Q50 MERIT MEDICAL BALLOON TO MOLD THE RINGS, THE NOSE CONE OF THE BALLOON BECAME CAUGHT ON THE DISTAL SUPRARENAL PORTION OF THE ALTO MAIN BODY, PUSHING THE ALTO MAIN BODY PROXIMALLY ABOUT 1CM AND PARTIALLY COVERING LEFT RENAL. ARM ACCESS WAS OBTAINED, AND THE LEFT RENAL WAS SUCCESSFULLY STENTED. THERE SEEMED TO BE SEAL IN THE NECK AT THE SECOND RING; HOWEVER, THE FINAL ANGIO SHOWED A POSSIBLE TYPE IA ENDOLEAK OR TYPE II ENDOLEAK. THE PATIENT LEFT THE OPERATING ROOM AND WAS BEING MONITORED. ADDITIONAL INFORMATION: DURING THE CLINICAL ASSESSMENT IT WAS IDENTIFIED THAT THERE WAS A TYPE 2 (NON ¿ DEVICE RELATED FAILURE), NOT A TYPE 1A ENDOLEAK. THE CLINICAL ASSESSMENT ALSO IDENTIFIED AN ILIAC OCCLUSION THAT OCCURRED (8) EIGHT DAYS AFTER THE INITIAL PROCEDURE AND THERE WAS ALSO A SUSPECTED ABDOMINAL ABSCESS OR INFECTION. THESE ADDITIONAL EVENTS THAT WERE IDENTIFIED WILL BE HANDLED UNDER A NEW COMPLAINT FILE.

  Patient problems: Failure of Implant

  MAUDE report 14454507 ↗
• InjuryMay 19, 2022Complete Blockage; Complete Blockage

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO STENT GRAFT SYSTEM (ONE ALTO MAIN BODY AND THREE (3) OVATION IX ILIAC LIMBS). POST-DEPLOYMENT, WHILE ATTEMPTING TO ADVANCE THE Q50 MERIT MEDICAL BALLOON TO MOLD THE RINGS, THE NOSE CONE OF THE BALLOON BECAME CAUGHT ON THE DISTAL SUPRARENAL PORTION OF THE ALTO MAIN BODY, PUSHING THE ALTO MAIN BODY PROXIMALLY ABOUT 1CM AND PARTIALLY COVERING LEFT RENAL. ARM ACCESS WAS OBTAINED, AND THE LEFT RENAL WAS SUCCESSFULLY STENTED. THERE SEEMED TO BE SEAL IN THE NECK AT THE SECOND RING; HOWEVER, THE FINAL ANGIO SHOWED A POSSIBLE TYPE IA ENDOLEAK OR TYPE II ENDOLEAK. THE PATIENT LEFT THE OPERATING ROOM AND WAS BEING MONITORED. (REPORTED UNDER MFR# 3008011247-2022-00047). SEVERAL HOURS POST-PROCEDURE THE PATIENT DEVELOPED A COLD LEG AND WAS BROUGHT BACK INTO THE OPERATING ROOM. THE RIGHT LIMB WAS NOT GETTING FLOW DO TO THE ALTO MAIN BODY LEGS BECOMING A LITTLE TWISTED AND OCCLUDING ON THE RIGHT SIDE. TWO NON-ENDOLOGIX BALLOON-EXPANDABLE STENTS WERE IMPLANTED AT THE LEVEL OF THE SECOND SEALING RING AND INTO THE LEGS OF THE MAIN BODY. NORMAL FLOW WAS ACHIEVED AND THE STENTING AT THE SECOND RING ALSO RESOLVED THE TYP

  Patient problems: Failure of Implant; Obstruction/Occlusion

  MAUDE report 14437641 ↗
• InjuryMay 19, 2022Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE ABSENCE OF AN INFRARENAL NECK. THE PHYSICIAN ELECTED TO PLACE THE ALTO SEALING RING BETWEEN THE RIGHT AND LEFT RENAL ARTERIES AND IMPLANTED A SINGLE RENAL CHIMNEY LIFESTREAM (NON-ENDOLOGIX) BALLOON EXPANDABLE STENT (BES) INTO THE LEFT RENAL ARTERY. A SEAL APPEARED TO HAVE BEEN ACHIEVED; HOWEVER, A TYPE 1A ENDOLEAK WAS LATER OBSERVED. THE PATIENT STATUS WAS REPORTED AS DISCHARGED.

  Patient problems: Failure of Implant; Pseudoaneurysm; Stenosis

  MAUDE report 14436237 ↗
• InjuryMay 9, 2022Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED AND THE PATIENT EXPERIENCED HYPOTENSION EVIDENCED BY A DROP IN BLOOD PRESSURE AND A RASH APPEARS ALL OVER THE BODY DUE TO A SUSPECTED POLYMER LEAK. THE PATIENT WAS TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU AND WAS STABILIZED WITHIN APPROXIMATELY 12 MINUTES. IT WAS NOTED THAT THE MAIN BODY LIMBS APPEARED CROSSED CAUSING DIFFICULTLY TO CANNULATE THE CONTRA LIMB. THE PROCEDURE WAS COMPLETED. THE NEXT MORNING, IT WAS REPORTED THAT THE RIGHT LIMB HAD BECAME OCCLUDED FROM TWO (2) CM ABOVE THE ILIAC BIFURCATION OF THE MAIN BODY TO THE COMMON FEMORAL. A FEMORAL ¿ FEMORAL BYPASS WAS PERFORMED TO RESTORE FLOW. THE PROCEDURE WAS COMPLETED WITH GOOD SEAL. THE PATIENT WAS REPORTED AS DOING FINE AND DISCHARGED THE NEXT DAY.

  Patient problems: Anaphylactic Shock; Failure of Implant; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Rash

  MAUDE report 14341316 ↗
• InjuryAug 6, 2021Malposition of Device; Patient-Device Incompatibility; Malposition of Device; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. IN ADDITION, THE MAIN BODY GRAFT TILTED TO THE RIGHT AND THE SEALING RINGS COVERED THE LEFT RENAL ARTERY. THE PHYSICIAN ELECTED TO BALLOON THE STENT GRAFT AND WHILE THE ENDOLEAK RESOLVED, THE RENAL REMAINED OCCLUDED. THE PATIENT IS REPORTEDLY STABLE AND HAS BEEN DISCHARGED.

  Patient problems: Failure of Implant

  MAUDE report 12290787 ↗
• InjuryJun 24, 2021Difficult to Advance; Insufficient Device Problem Information; Difficult to Advance; 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, THE PHYSICIAN HAD DIFFICULTLY WHEN ADVANCING AND DEPLOYING THE INTEGRATED BALLOON CAUSING THE MAIN BODY (STENT GRAFT) TO MOVE UPWARD ENCROACHED ON THE LOWEST RIGHT RENAL ARTERY. THE PHYSICIAN DECIDED TO USE A NON-ENDOLOGIX (CODA) BALLOON TO PULL THE STENT GRAFT BACK DOWN TO ITS ORIGINAL POSITION AND WAS ABLE TO MOVE IT DOWN A COUPLE MILLIMETERS. THERE WAS AN INTRAOPERATIVE TYPE 1A ENDOLEAK AT THE END OF THE CASE. AFTER FURTHER BALLOONING THE ENDOLEAK LOOKED IMPROVED AND BOTH RENAL ARTERIES WERE FILLING. THE PATIENT IS DOING WELL AND WAS DISCHARGED. ADDITIONAL INFORMATION: UPON THE INTERNAL REVIEW OF THE ONE MONTH POST COMPUTED TOMOGRAPHY (CT) STUDY THE TYPE 1A ENDOLEAK WAS FOUND TO HAVE RESOLVED AND THERE WAS A TYPE 2 ENDOLEAK FROM THE INFERIOR MESENTERY ARTERY.

  Patient problems: Failure of Implant

  MAUDE report 12059707 ↗

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