Alto™ Abdominal Stent Graft System TV-AB2380-N (UDI 00850007370886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00850007370886), received between Jul 1, 2021 and Aug 13, 2026 — classified as 4 deaths, 40 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Lack of Effect” (13 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Off-Label Use; Obstruction of Flow

  Patient problems: Bacterial Infection; Ischemia; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 50240493 ↗
• InjuryMar 31, 2026Malposition of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM WHICH RESULTED IN UNTREATED RIGHT RENAL OCCLUSION. THE ALTO MAIN BODY DELIVERY SYSTEM WAS INSERTED VIA A RIGHT APPROACH. THE RENAL ARTERIES WERE CONTRAST-IMAGED TO IDENTIFY THEIR APPROXIMATE LOCATIONS. AFTER THE MID-CROWN OF THE ALTO MAIN BODY WAS DEPLOYED, BALLOON EXPANSION WAS PERFORMED. FOLLOWING PARALLAX ADJUSTMENT, RENAL ARTERY ANGIOGRAPHY WAS PERFORMED AGAIN. AFTER INJECTING THE POLYMER FILL AND CONFIRMING THAT THE SEALING RING POSITION WAS APPROPRIATE, THE PROXIMAL CROWN WAS DEPLOYED. CONTRALATERAL CANNULATION WAS PERFORMED USING THE CROSSOVER LUMEN. FOURTEEN MINUTES LATER, BALLOON EXPANSION WAS CARRIED OUT FOR TWO MINUTES. AT THIS POINT, IT WAS OBSERVED THAT THE ALTO MAIN BODY SEALING RING WAS SLIGHTLY OVERLAPPING THE RIGHT RENAL ARTERY, AND THE BLOOD FLOW IN THE RIGHT RENAL ARTERY WAS DELAYED; THEREFORE, CORRECTIVE ACTION WAS TAKEN. A SHEATH WAS INSERTED VIA THE LEFT ARM, AND AN ATTEMPT WAS MADE TO CANNULATE THE RENAL ARTERY, BUT IT WAS UNSUCCESSFUL. FOLLOW-UP ANGIOGRAPHY REVEALED THAT THE RENAL ARTERY WAS COMPLETELY OCCLUDED. WHEN CANNULATION WA

  Patient problems: Obstruction/Occlusion

  MAUDE report 24744067 ↗
• InjuryMar 30, 2026Device Stenosis

  THE PATIENT WAS TREATED FOR ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY WERE EMBOLIZED WITH COILS. A GORE (NON-ENDOLOGIX) 26X33 CUFF WAS DEPLOYED TO EMBOLIZE THE PROXIMAL LUMBAR ARTERY. THE ALTO MAIN BODY WAS DEPLOYED VIA RIGHT ACCESS. CONTRALATERAL CANNULATION WAS COMPLETED WITHIN 7 MINUTES OF DEPLOYMENT. THE CONTRALATERAL OVATION IX ILIAC LIMB WAS DEPLOYED. BALLOON TOUCH UP WAS PERFORMED AT FOURTEEN MINUTES ON THE PROXIMAL PORTION OF THE ALTO MAIN BODY, FOLLOWED BY THE DEPLOYMENT OF THE IPSILATERAL OVATION IX ILIAC LIMB. AFTER BALLOONING THE JUNCTIONS BETWEEN THE LIMBS AND THE ALTO MAIN BODY, THE PROCEDURE WAS COMPLETED WITH NO ENDOLEAKS. FOLLOWING DISCHARGE, ON (B)(6) 2026, THE PATIENT COMPLAINED OF LEFT LEG PAIN. EXAMINATION REVEALED STENOSIS IN THE PROXIMAL PORTION OF THE LEFT LEG OF THE ALTO MAIN BODY. THE STENOSIS WAS TREATED WITH DEPLOYMENT OF A BARE METAL STENT (NON-ENDOLOGIX), AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE POSITIONING HEIGHT OF THE LEFT AND RIGHT LIMBS DIFFERED BY APPROXIMATELY ONE MARKER. THE STENOSIS WAS LIKELY TO HAVE OCCURRED BECAUSE THE ANATOMY AT IR+40 BEING RELATIVELY NARROW AND THERE WAS I

  Patient problems: Pain; Stenosis

  MAUDE report 24715120 ↗
• InjuryFeb 24, 2026Fluid/Blood Leak

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. EIGHT MINUTES INTO THE INITIAL PROCEDURE THE PATIENT BECAME UNSTABLE AND BLOOD PRESSURE DROPPED. THE POLYMER RINGS LOST THEIR CONTRAST, THE AUTO INJECTOR WAS REMOVED AND ANESTHESIA WAS INFORMED. ANESTHESIA INTUBATED THE PATIENT, GOT BLOOD PRESSURE UNDER CONTROL AND PLACED PATIENT ON A VENTILATOR. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT (NON-ENDOLOGIX)TO STABILIZE THE SEALING RINGS OF THE ALTO MAIN BODY. THE ANEURYSM WAS EXCLUDED AND POST COMPUTED TOMOGRAPHY ANGIOGRAPHY TAKEN ONE HOUR LATER LOOKED GOOD. THE PATENT WAS THEN SENT TO THE INTENSIVE CARE UNIT. THE FOLLOWING DAY THE PATIENT WAS EXTUBATED, RESPONDING TO COMMANDS, AND MOVING ARMS AND LEGS. THE PATIENT IS IN A REHAB FACILITY OUT OF THE HOSPITAL AND HAS HAD A LOT OF BLOOD TRANSFUSIONS DUE TO A HEMATOMA NOT RELATED TO THE PROCEDURE. PATIENT SORES ON BACK ARE CLEARING UP.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24433857 ↗
• InjuryDec 30, 2025Deformation Due to Compressive Stress; Device Stenosis; Deformation Due to Compressive Stress; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH AN ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. AFTER DELIVERING AND DEPLOYING THE ALTO MAIN BODY VIA THE LEFT ACCESS, THE CUSTOMSEAL POLYMER FILL WAS PERFORMED. THE FILLING WAS SLIGHTLY DELAYED DUE TO THE NARROWNESS OF THE AORTA. THE POLYMER FILL WAS SUCCESSFULLY COMPLETED, REACHING THE CONTRALATERAL SIDE WITHOUT ISSUES. SUBSEQUENTLY, CANNULATION WAS PERFORMED USING THE CROSS-OVER LUMEN. BILATERAL OVATION IX ILIAC LIMB WERE IMPLANTED ONE ON THE CONTRALATERAL SIDE, AND ONE ON THE IPSILATERAL SIDE. THE FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS, AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED ON (B)(6) 2025; THERE WAS A DECREASE IN THE RIGHT LEG ANKLE-BRACHIAL INDEX (ABI) FROM 1.0 TO 0.7. THE COMPUTED TOMOGRAPHY (CT) REVEALED STENOSIS AT THE ORIGIN OF THE ALTO MAIN BODY RIGHT LEG AND AT THE PROXIMAL END IN THE CONTRALATERAL OVATION IX ILIAC LIMB (RIGHT LEG). THE PHYSICIAN STATED THAT THE ILIAC LIMB BECAME TWISTED BECAUSE THE PROXIMAL SECTION WAS POSITIONED IN THE THINNEST PORTION OF THE LONG NECK (16¿18 MM). FURTHERMORE, THE PROXIMAL ENDS OF THE BILATERAL LIMBS WERE POSITIONED DIFFERENTLY (LEFT HIGHER, RIGHT LOWER)

  Patient problems: Stenosis

  MAUDE report 23930560 ↗
• InjuryNov 6, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. REPORTEDLY THE PATIENT HAD AN ANEURYSM MEASURING 51.7CM. THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA; THEN THE PATIENT WAS PLACED AND PREPPED ON THE OPERATING ROOM TABLE IN NORMAL FASHION. BILATERAL COMMON FEMORAL ACCESS WAS OBTAINED. BILATERAL ABBOTT (NON-ENDOLOGIX) PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEMS WERE SUCCESSFULLY DEPLOYED. THE PATIENT HAD VERY TORTUOUS BILATERAL ILIAC ANATOMY. THE ALTO 23 MM AORTIC BODY WAS PREPPED AND DELIVERED WITHOUT ISSUE. THE DEPLOYMENT OF THE MAIN BODY WAS PERFORMED AS PER THE INSTRUCTIONS FOR USE (IFU) STEPS. THE MIDCROWN WAS BALLOONED WITH 5 ML TO EXPAND THE PROXIMAL PORTION OF THE MAIN BODY AND THE GRAFT WAS FIXATED. THE POLYMER WAS INTRODUCED AND IT TOOK ABOUT 90 SECONDS TO COMPLETELY FILL THE DEVICES. IN THE SEALING LEVEL OF THE GRAFT THERE WAS EVIDENCE OF CALCIFICATION IN THE SEALING ZONE COMBINED WITH A REVERSED TAPERED NECK. THE REST OF THE PROCEDURE WAS COMPLETED AS IFU REQUIREMENTS STATE WITH BALLOON OF THE SEALING RING AT 14 ½ MINS AND PLACEMENT OF THE OVATION IX LIMBS (16X140 LEFT, 10X1

  Patient problems: Clinical Endoleak

  MAUDE report 23487112 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR A FUSIFORM ANEURYSM WITH ENDOVASCULAR REPAIR (EVAR) ON (B)(6) 2022 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. AFTER EMBOLIZING THE INFERIOR MESENTERIC ARTERY (IMA) WITH COILS, THE ALTO MAIN BODY WAS INSERTED AND DEPLOYED VIA A RIGHT APPROACH ACCORDING TO THE INSTRUCTIONS. AFTER 14 MINUTES OF POLYMER FILL, CONTRALATERAL CANNULATION WAS PERFORMED. THE CONTRALATERAL OVATION IX LIMB AND THE IPSILATERAL OVATION IX LIMB WERE THEN DEPLOYED. AFTER A TOUCH-UP, NO ENDOLEAKS WERE CONFIRMED, AND THE PROCEDURE WAS COMPLETED. DURING THE FOLLOW-UP CONDUCTED BEFORE DISCHARGE ON (B)(6) 2022, A TYPE II ENDOLEAK WAS CONFIRMED, BUT IT WAS DEEMED THAT NO TREATMENT WAS REQUIRED. AT A FOLLOW-UP ON (B)(6) 2024, THERE WAS NO ANEURYSM ENLARGEMENT CONFIRMED. HOWEVER, ANEURYSM ENLARGEMENT SUBSEQUENTLY BEGAN, AND OPEN SURGERY WAS PERFORMED ON (B)(6) 2025, AS THE TYPE OF ENDOLEAK HAD NOT BEEN DEFINITIVELY IDENTIFIED. A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY WAS ULTIMATELY CONFIRMED BY OPEN SURGERY. IT REMAINS UNKNOWN WHEN THE ANEURYSM ENLARGEMENT BEGAN. DURING OPEN SURGERY, BLOOD FLOW WAS BLOCKED BY A BALLOON CATHETER AROUND THE PROXIMAL RING OF THE ALTO MAI

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23316744 ↗
• InjuryAug 15, 2025Malposition of Device; Malposition of Device

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM (AASGS) ON (B)(6) 2025. THE INTERNAL MESENTERIC ARTERY (IMA) WAS COILED PRIOR TO THE INSERTION OF THE AASGS. IT WAS REPORTED THAT THE ALTO MAIN BODY WAS INSERTED VIA THE RIGHT SIDE, AND THE PROXIMAL CROWN WAS DEPLOYED SO THAT THE PROXIMAL MARKER OF THE AASGS INTEGRATED BALLOON WAS POSITIONED APPROXIMATELY 1MM BELOW THE INFRARENAL ARTERY, WITH THE METALLIC PORTION DIRECTLY BELOW THE RADIOPAQUE MARKER AS A GUIDE, ENSURING THE RING WAS INFRARENAL. AFTER THE POLYMER FILL, IT WAS DETERMINED THAT CONTRALATERAL LIMB PLACEMENT WITHIN 14 MINUTES WOULD BE DIFFICULT. THEREFORE, BALLOON TOUCH-UP WAS PERFORMED BEFORE CONTRALATERAL LIMB PLACEMENT. AT THAT TIME, A BEHAVIOR SUGGESTIVE OF EXPANSION OF THE PROXIMAL RING WAS OBSERVED. BOTH THE CONTRALATERAL AND IPSILATERAL LIMBS WERE DEPLOYED, AND FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS. HOWEVER, IT WAS CONFIRMED THAT THE LEFT RENAL ARTERY WAS APPROXIMATELY 80% COVERED BY THE PROXIMAL RING. TO RESOLVE THE LEFT RENAL ARTERY OCCLUSION, CANNULATION FROM THE LEFT BRACHIAL ARTERY TO THE LEFT RENAL ARTERY WAS ATTEMPTED. A 0.0

  Patient problems: Obstruction/Occlusion

  MAUDE report 22816860 ↗
• InjuryJul 16, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT A FUSIFORM SHAPED ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE AN ANGIOGRAM SHOWED PERSISTENCE OF A TYPE 1A ENDOLEAK. THE LOCATION OF THE ENDOLEAK WAS IDENTIFIED USING A MICROCATHETER. THE ANEURYSM WAS FOUND TO HAVE ENLARGED BY 4MM COMPARED TO THE POST-OPERATIVE COMPUTED TOMOGRAPHY (CT). THE PHYSICIAN ELECTED TO IMPLANT TWO (NON-ENDOLOGIX) COILS TO SUCCESSFULLY RESOLVE THE ENDOLEAK. ADDITIONALLY, A TYPE 2 (NON-DEVICE RELATED) ENDOLEAK WAS CONFIRMED; HOWEVER, BUT THE ANEURYSM DIAMETER DID NOT CHANGE. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22522703 ↗
• InjuryMay 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. RIGHT FEMORAL ARTERY ACCESS WAS GAINED. THE ALTO MAIN BODY RADIO OPAQUE MARKER WAS PLACED TO ALIGN WITH THE CENTER OF A RENAL ARTERY AND IT WAS DEPLOYED. POLYMER INJECTION WAS COMPLETED WITHOUT ANY PROBLEMS. IT WAS THEN NOTICED THAT THE ALTO MAIN BODY WAS PLACED SLIGHTLY LOWER THAN EXPECTED. BEFORE PLACING THE CONTRALATERAL LEG, BALLOON TOUCH-UP WAS PERFORMED AFTER 14 MINUTES WITH THE INTEGRATED BALLOON. THE INTEGRATED BALLOON WAS EXPANDED BY 8CC OF INFLATION VOLUME PER IFU WITHOUT BEING ADVANCED PROXIMALLY. AT THAT MOMENT, THE ALTO MAIN BODY MIGRATED PROXIMALLY APPROXIMATELY ONE SEALING RING WIDTH. AN ANGIOGRAPHY WAS PERFORMED IDENTIFYING THAT THE SEALING RING INTERFERED WITH THE RIGHT AND LEFT RENAL ARTERIES. A BARE METAL STENT WAS IMPLANTED AT THE LEFT RENAL ARTERY AND BLOOD FLOW WAS MAINTAINED. THE RIGHT RENAL ARTERY WAS COMPLETELY OCCLUDED BY THE SEALING RING. BLOOD FLOW WAS NOT CONFIRMED, AND NO FURTHER TREATMENT WAS TAKEN. THE RIGHT AND LEFT OVATION IX ILIAC LIMBS WERE IMPLANTED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22052732 ↗
• MalfunctionApr 25, 2025Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. THE DELIVERY SYSTEM WAS INSERTED THROUGH THE LEFT ACCESS, AND THE ALTO MAIN BODY WAS DEPLOYED. AFTER MIXING THE SYRINGES OF THE POLYMER FILL KIT AT THE SPECIFIED NUMBER OF TIMES AND SPEED, INJECTION TO THE DELIVERY SYSTEM COMMENCED BY USING THE AUTOINJECTOR. POLYMER WAS FILLED INTO THE IPSILATERAL LEG, BUT IT WAS NOT FILLED INTO THE SEALING RING NOR THE CONTRALATERAL LEG. AFTER ADJUSTING THE POSITION OF THE SHEATH, SLIGHTLY PUSHING, PULLING AND TURNING THE DELIVERY SYSTEM, POLYMER WAS FILLED INTO THE SEALING RING. HOWEVER, IT WAS NOT STILL FILLED INTO THE CONTRALATERAL LEG. THE AUTOINJECTOR WAS REPLACED, BUT THAT DID NOT HELP. BECAUSE 14 MINUTES HAD PASSED SINCE THE INJECTION, THE PROCEDURE WAS CONTINUED. AFTER EXPANDING THE SEALING RING WITH THE INTEGRAL BALLOON, THE ANGIOGRAPHY CONFIRMED THERE WERE NO ENDOLEAKS. THE OVATION IX LEFT AND RIGHT LIMBS WERE SUCCESSFULLY IMPLANTED. THEN, BALLOON TOUCH-UP WAS PERFORMED, AND THE ANGIOGRAPHY CONFIRMED THERE WERE NO ENDOLEAKS. THE PROCEDURE WAS COMPLETED. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910610 ↗
• InjuryJan 10, 2025Lack of Effect; Lack of Effect

  THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2022, WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY SIX (6) MONTHS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, IT WAS FOUND THAT THE AORTIC ANEURYSM HAD INCREASED APPROXIMATELY 15MM. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm

  MAUDE report 21125097 ↗
• InjuryDec 10, 2024Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. IT WAS REPORTED THAT THREE MONTHS POST INDEX PROCEDURE (APPROXIMATELY (B)(6) 2024 A FOLLOW UP POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A SLIGHT INDETERMINATE ENDOLEAK. THE PATIENT WAS MONITORED. ON (B)(6) 2024 ANOTHER FOLLOW UP ANGIOGRAPHY SHOWED INCREASE IN THE PREVIOUSLY SEEN INDETERMINATE ENDOLEAK WHICH WAS COMING FROM THE BIFURCATED SECTION OF THE ALTO MAIN BODY, THE PHYSICIAN SUSPECTED THAT IT COULD BE A TYPE IIIB ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 20894571 ↗
• InjuryNov 22, 2024Off-Label Use; Material Puncture/Hole; Malposition of Device; Difficult to Advance; Off-Label Use; Material Puncture/Hole; Malposition of Device; Difficult to Advance

  DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE THE PATIENT WAS TREATED WITH THE IMPLANT OF THE AFX VELA INFRARENAL, FOLLOWED BY THE ALTO MAIN BODY, BOTH THROUGH THE LEFT ACCESS. THIS PROCEDURE WAS OFF-LABEL DUE TO THE AFX VELA INFRARENAL BEING IMPLANTED FIRST. ALTHOUGH THE ALTO MAIN BODY WAS PROPERLY ALIGNED, THE LIMB WAS SLIGHTLY TWISTED AND POSITIONED NEAR THE RENAL ARTERIES, WITH LESS-THAN-IDEAL VISUALIZATION. INSERTION OF THE OVATION IX LIMB ENCOUNTERED DIFFICULTIES PAST THE FOURTH RING, LIKELY DUE TO INTERFERENCE WITH THE VELA STENT OR DEFLECTIONS IN THE CONTRALATERAL LEG. INITIAL ATTEMPTS TO ADJUST THE (DRYSEAL) SHEATH FAILED. AFTER FURTHER REPOSITIONING, THE LIMB ADVANCED SUCCESSFULLY. DURING ANGIOGRAPHY, 70% TO 80% OF SUPERIOR MESENTERIC ARTERY (SMA) WAS OCCLUDED, (NON-ENDOLOGIX) VBX STENTS WERE DEPLOYED IN THE RENAL ARTERY TO ADDRESS THIS. THE PHYSICIAN BELIEVES THAT THE EVENT MAY HAVE BEEN CAUSED BY DEFLECTIONS AND WRINKLES, A PERFORATION NEAR THE FOURTH RING INSIDE THE MAIN BODY CAUSED BY THE GUIDE WIRE, OR INTERFERENCE WITH ANOTHER OBJECT. THE PROCEDURE CONCLUDED WITH THE IMPLANTATION OF AN ADDITIONAL OVATION IX LIMB ON THE IPSILATERAL SIDE, WITH NO ENDOLEAK DE

  Patient problems: Ischemia

  MAUDE report 20759129 ↗
• InjuryNov 11, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. ROUTINE FOLLOW-UP CONDUCTED A COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2024 WHICH IDENTIFIED THE DEVICE LIMBS ARE CRIMPED IN THE UNSUPPORTED PORTION OF THE GRAFT. THE PHYSICIAN ELECTED TO PUT IN GORE (NON-ENDOLOGIX) VBX STENTS DURING REINTERVENTION WHICH WAS COMPLETED ON (B)(6) 2024. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Clinical Endoleak; Stenosis

  MAUDE report 20653157 ↗
• InjuryOct 29, 2024Filling Problem; Off-Label Use; Patient-Device Incompatibility; Filling Problem; Off-Label Use; Patient-Device Incompatibility

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DUE TO EXCESSIVE AORTIC TORTUOSITY, THE MAIN BODY WAS DELIVERED WITH THE ORIENTATION ADJUSTED SO THAT THE POLYMER CHANNELS WERE NOT IN THE TORTUOUS SECTION. THE STENT CROWN WAS SUCCESSFULLY DEPLOYED AND THE POLYMER FILLING WAS STARTED. IT WAS NOTED THAT THE POLYMER FILLING SPEED WAS INITIALLY SLOW AND THERE WAS NO POLYMER FILLING IN THE THIRD RING ON THE IPSILATERAL SIDE. THE DELIVERY SYSTEM WAS MANEUVERED AND THE SHEATH AND GUIDE WIRE WERE PULLED; HOWEVER, NO IMPROVEMENT WAS OBSERVED. THE INTEGRATED BALLOON WAS INFLATED BUT THAT DID CHANGE THE SITUATION. THE PHYSICIAN DECIDED TO DISCONTINUE ATTEMPTS AT FILLING THE POLYMER AS 10 MINUTES HAD ELAPSED SINCE THE MIXING OF THE POLYMER. TWO (NON-ENDOLOGIX) GORE LEGS WERE PLACED ON THE CONTRALATERAL SIDE AND FOLLOWING THE REMOVAL OF THE DELIVERY SYSTEM. THEN A GORE 23MMX3.3CM CUFF WAS PLACED PROXIMALLY AND A GORE EXCLUDER 14.5MMX12CM LEG WAS PLACED IN THE IPSILATERAL LEG. A SUBSEQUENT TOUCH-UP AND CONTRAST EXAMINATION REVEALED THE PERSISTENCE OF A TYPE IIIA ENDOLEAK, NECESSITATING A FURTHER TOUCH-UP PROCEDURE. WHILE THE ENDOLEAK D

  Patient problems: Clinical Endoleak

  MAUDE report 20560227 ↗
• InjuryAug 5, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INDEX PROCEDURE DURING FOLLOW-UP, A POTENTIAL TYPE IIIA ENDOLEAK WAS FOUND. THE INTERVENTION SCHEDULED FOR (B)(6) 2024 WAS FOUND TO BE CANCELLED ON (B)(6) 2024. THE PATIENT IS REPORTED AS BEING STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 19907400 ↗
• DeathApr 26, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WAS TRANSPORTED TO A HOSPITAL OTHER THAN THE IMPLANT FACILITY ON (B)(6) 2023 BUT PASSED AWAY DUE TO AN ACUTE AORTIC DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 19192241 ↗
• DeathApr 23, 2024Malposition of Device; Malposition of Device

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE DEVICE WAS BROUGHT UP THE LEFT SIDE TO LAND ON THE RIGHT RENAL. THE AORTIC NECK WAS 10MM BUT ANGULATED. THE DEVICE ENDED UP BEING STRAIGHTER IN THE AORTA THAN ANTICIPATED. SO, WHEN LANDING OFF THE MIDDLE OF THE RIGHT IT COULD BE SEEN THAT THE LEFT SIDE OF THE DEVICE WAS GOING TO BE A LITTLE BIT LOW. THE PHYSICIAN WAS ADVISED TO TRY TO PUSH THE DEVICE UP A LITTLE BIT, BUT THIS WAS UNSUCCESSFUL. SO, WITH THE MARKERS IN THE MIDDLE OF THE RIGHT RENAL THE ALTO MAIN BODY WAS DEPLOYED, AND THE FILL POLYMER WAS CONNECTED. GATE CANNULATION WAS PERFORMED USING THE CROSSOVER LUMEN. THE ENTIRE PROCEDURE WAS UNREMARKABLE. THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK. BALLOONING WAS PERFORMED WITH A CODA BALLOON; HOWEVER, IT WAS UNSUCCESSFUL. THE FACILITY HAD RUN OUT OF PALMAZ STENTS, AND SINCE THE PATIENT WAS SYMPTOMATIC, THE PHYSICIAN ELECTED TO DEPLOY A MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFF AND LASER FENESTRATE INTO THE SUPERIOR MESENTERIC ARTERY (SMA) AND BOTH RENALS. THE PHYSICIAN WAS ABLE TO STENT ALL THREE OF THE VESSELS SUCCESSFULLY IN PREPA

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 19168551 ↗
• InjuryMar 5, 2024Filling Problem; Fluid/Blood Leak; Filling Problem; Fluid/Blood Leak

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. REPORTEDLY, DURING POLYMER FILL, AT 7 MINUTES THERE WAS UNDER-FILLING OF THE CONTRALATERAL GATE. THE PHYSICIAN INFLATED THE INTEGRATED BALLOON CAUSING THE POLYMER TO FILL THE CONTRALATERAL LIMB. SOON AFTER IT WAS NOTICED THAT THE POLYMER SYRINGE HAD BOTTOMED OUT. THE PATIENT BECAME HYPOTENSIVE. THE ANESTHESIOLOGIST TREATED THE PATIENT WITH EPINEPHRINE, BENADRYL, AND CORTICOSTEROIDS. THE PATIENT WAS PLACED ON NOREPINEPHRINE DRIP FOR ANOTHER 15-20 MINUTES AS THE GRAFT IMPLANTATION WAS COMPLETED. THE FINAL ANGIOGRAM SHOWED A TYPE IA ENDOLEAK DUE TO UNDERFILLING OF THE RINGS. A 14 FRENCH SHEATH WAS PLACED AND A NON-ENDOLOGIX PALMAZ P4010 WAS PLACED USING A 32MM COOK CODA BALLOON. THIS RESOLVED THE TYPE IA ENDOLEAK. THE NOREPINEPHRINE WAS DISCONTINUED 15-20 MINUTES BEFORE THE END OF THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE. NO ENDOLEAKS WERE PRESENT AT THE END OF THE CASE. PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT IS NEUROLOGICALLY INTACT, ABLE TO MOVE ALL LIMBS AND COMPLAINS OF SOME LOW BACK PAIN. COMPUTED TOMOGRAPHY SCAN PERFO

  Patient problems: Clinical Endoleak; Low Blood Pressure/ Hypotension

  MAUDE report 18838253 ↗
• InjuryJan 12, 2024Deformation Due to Compressive Stress; Lack of Effect; Deformation Due to Compressive Stress; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM, AN ADDITIONAL OVATION IX ILIAC LIMB, AND AN OVATION IX EXTENDER. REPORTEDLY, THERE WAS HEAVY TORTUOSITY IN THE NECK. THE PATIENT HAD CALLED INTO THE PHYSICIAN¿S OFFICE WITH A COMPLAINT OF LEG PAIN. ON 02 JANUARY 2024, COMPUTED TOMOGRAPHY SCANS WERE PERFORMED. THE FIRST SHOT IDENTIFIED A TYPE IA ENDOLEAK THAT WAS TREATED SUCCESSFULLY WITH THE IMPLANT OF B BRAUN (NON-ENDOLOGIX) COVERED CP STENT (IDEAL PALMAZ SIZE WAS NOT AVAILABLE) AND BALLOONING. ADDITIONALLY, THERE WAS RIGHT LIMB ISCHEMIA. DUE TO THE WAY THE ALTO MAIN BODY WAS SITTING AT THE BIFURCATION, THE PHYSICIAN ELECTED TO TREAT THE RIGHT AND LEFT SIDES. THE RIGHT SIDE WAS TREATED WITH THE IMPLANT OF A GORE (NON-ENDOLOGIX) VBX 11X59MM AND TWO (2) GORE VBX 11X79MM. THE LEFT SIDE WAS TREATED WITH THE IMPLANT OF TWO (2) GORE VBX 11X59MM. THE PROCEDURE WENT WELL. PATIENT WAS REPORTED TO BE GOOD ONE DAY POST-OPERATION.

  Patient problems: Clinical Endoleak; Ischemia; Pain

  MAUDE report 18507046 ↗
• InjuryJan 9, 2024Malposition of Device; Lack of Effect; Malposition of Device; 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 (2) OVATION IX ILIAC LIMBS, AND OVATION PRIME FILL POLYMER. REPORTEDLY, THE PATIENT HAD A REVERSE TAPER, CALCIFIED, SHORT NECK WITH SMALL ACCESS. ALTO MAIN BODY APPEARED TO SINK DOWN A COUPLE MILLIMETERS AS THE POLYMER WENT IN CAUSING THE ALTO MAIN BODY TO SETTLE INTO THE REVERSE TAPER NECK. APPROXIMATELY EIGHTY-TWO (82) DAYS FOLLOWING THE INITIAL PROCEDURE, A POSTOPERATIVE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE PRESENCE OF AN ENDOLEAK OF INDETERMINATE ORIGIN. THE PATIENT IS CURRENTLY REPORTED TO BE IN STABLE CONDITION. THE ATTENDING PHYSICIAN IS ACTIVELY EVALUATING POTENTIAL RE-INTERVENTION OPTIONS.

  Patient problems: Clinical Endoleak

  MAUDE report 18477691 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; 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). THERE WERE NO ISSUES OR COMPLICATIONS OR ABNORMALITIES WITH THE IMPLANTED PROCEDURE: HOWEVER, THE PATIENT HAD PARALYSIS OF THE LOWER BODY. THE PHYSICIAN SUSPECTS THE PATIENT HAS ANOMALIES. IT WAS NOTED THAT THE ARTERY OF ADAMKIEWICZ WAS BYPASSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Paralysis

  MAUDE report 18163030 ↗
• InjuryOct 11, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIXTY-TWO (62) DAYS POST-INITIAL PROCEDURE THE PHYSICIAN IS QUESTIONING THE PRESENCE OF AN ENDOLEAK TYPE IA. THE PATIENT UNDERWENT A SECONDARY PROCEDURE INVOLVING THE EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA). LIMITED INFORMATION IS AVAILABLE AND THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 17916551 ↗
• InjuryAug 22, 2023Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. REPORTEDLY, UPON ATTACHING THE AUTO INJECTOR TO THE ALTO MAIN BODY, THE SYRINGE STOPPED AT 6CC. THE DEVICE WAS MOUNTED ON A TERUMO GLIDEWIRE ADVANTAGE WHICH IS NOT THE NORMAL STIFFNESS. THE PHYSICIAN FOUND NO RELATIONSHIP WITH THE GUIDEWIRE STIFFNESS AND THE SYRINGE STOPPING AT 6CC. AT APPROXIMATELY ONE MINUTE THE SYRINGE WAS STILL STUCK ON 6CC. THE PHYSICIAN TOOK OFF THE AUTO INJECTOR AND RE-ATTACHED IT. THIS ALLOWED THE GRAFT TO FILL, AND IT STOPPED AT APPROXIMATELY 3CC. THE PATIENT¿S BASELINE PRESSURE WAS 124 SYSTOLIC. APPROXIMATELY 5 MINUTES INTO GATE CANNULATION IT WAS NOTICED THE SYRINGE WAS EMPTY AND NOTED PATIENT¿S PRESSURE IN THE 70S AND THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) BEGAN DOSING BENADRYL AND EPINEPHRINE. THE PATIENT PRESSURE GOT UP INTO THE 80S. THE GRAFT STILL APPEARED FILLED. PATIENT PRESSURE DROPPED BACK INTO THE 70S OCCASIONALLY OVER THE NEXT 3 MINUTES. ONCE THE LIMB WAS ATTACHED AND GRAFT DETACHED AT 14 MINUTES, THE CRNA HAD GIVEN A LARGE QUANTITY OF EPINEPHRINE AND PATIENT PRESSURE GOT UP IN THE 230S. GRADUALLY

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 17598193 ↗

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