Alto™ Abdominal Stent Graft System TV-AB2680-N (UDI 00850007370893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00850007370893), received between Jul 27, 2021 and Mar 5, 2026 — classified as 5 deaths, 44 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (10 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. ON (B)(6) 2026, DURING A ROUTINE FOLLOW UP, A TYPE IA ENDOLEAK WAS IDENTIFIED. ON (B)(6) 2026 THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT (NON-ENDOLOGIX) BUT IT COULD NOT BE DELIVERED. THE PHYSICIAN ELECTED TO FILL THE SAC WITH COILS (NON-ENDOLOGIX) AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 24522231 ↗
• InjuryMar 3, 2026Fluid/Blood Leak; Material Puncture/Hole

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2026. THE GRAFT WAS PLACED BELOW THE LOWEST LEFT RENAL AND THE POLYMER WAS MIXED WITH 20 STROKES. THE POLYMER WAS CONNECTED WITHIN LESS THAN A MINUTE AND WAITED TO FILL THE RINGS. AFTER FIVE (5) MINUTES OF FULLY FILLING THE RINGS THE ANESTHESIOLOGIST MENTIONED THE PATIENT¿S BLOOD PRESSURE PLUMMETED AND INQUIRED IF THE ILIAC ARTERY WAS RUPTURED. IT WAS NOTED THAT THE POLYMER SYRINGE WAS NOTED TO HAVE BOTTOMED OUT. THE PHYSICIAN TOOK A CONTRAST RUN WHICH DID NOT SHOW ANY EXTRAVASATION. THE ANESTHESIOLOGIST WAS REQUESTED TO ADMINISTER EPINEPHRINE, BENADRYL AND STEROIDS TO TREAT FOR A POLYMER ALLERGIC REACTION. THE PATIENT WAS STABILIZED AND THE PROCEDURE WAS CONTINUED WITH PLACEMENT OF THE ILIAC LIMBS AND THE AAA WAS SEALED. THE PATIENT WAS EXTUBATED AND SENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24502641 ↗
• InjuryAug 15, 2025Malposition of Device; Malposition of Device

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE IMPLANT OF THE ALTO ABDOMINAL GRAFT SYSTEM ON (B)(6) 2024. REPORTEDLY, CALCIFICATION WAS OBSERVED AROUND THE RENAL ARTERIES, AND THE NECK ANGLE WAS 45 DEGREES. AFTER EMBOLIZING THE LUMBAR ARTERY, THE ALTO MAIN BODY WAS DEPLOYED; POSITIONED SLIGHTLY MORE PROXIMAL THAN PLANNED. BALLOON TOUCH-UP WAS PERFORMED AT 14 MINUTES POST POLYMER FILL. ANGIOGRAPHY SHOWED THE SEALING RING WAS FLOATING, BUT THE SUPPORT RINGS WERE APPOSED TO THE VESSEL, CONFIRMING THAT THERE WERE NO ENDOLEAKS. THE BILATERAL LIMBS WERE DEPLOYED, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2025, A TYPE IA ENDOLEAK WAS CONFIRMED. REINTERVENTION IS PLANNED TO ADD A CUFF AND COILS; HOWEVER, THE DATE HAS NOT YET BEEN PROVIDED.

  Patient problems: Clinical Endoleak

  MAUDE report 22817587 ↗
• InjuryAug 1, 2025Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA) ON JULY 10, 2025 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE ALTO ABDOMINAL STENT GRAFT DELIVERY SYSTEM WAS DEPLOYED AS USUAL. IT WAS REPORTED THAT THE POLYMER FILL WAS NOT COMPLETELY FILLING ALL THE RINGS. THE PHYSICIAN ATTEMPTED TO IMPROVE THE INCOMPLETE POLYMER FILLING WITH THE FOLLOWING MANIPULATIONS: PUSHING UP OR PULLING DOWN THE DELIVERY SYSTEM BY 2-3 MM, PULLING DOWN THE STIFF GUIDEWIRE, INFLATING THE INTEGRATED BALLOON (WITH A SMALLER AMOUNT THAN THE DESIGNED VOLUME), SLOWLY ROTATING THE HANDLE OF THE DELIVERY SYSTEM CLOCKWISE AND COUNTER-CLOCKWISE, EACH IN ONE DIRECTION WITHIN 90 DEGREES. DESPITE THESE MANIPULATIONS THE POLYMER FILLED ONLY TO THE THIRD AND FOURTH RINGS. THE POLYMER DID NOT FILL INTO THE FIRST AND SECOND RINGS. AFTER FOURTEEN MINUTES HAD PASSED, THE PHYSICIAN DETERMINED FURTHER FILLING WOULD BE DIFFICULT, AND THE BILATERAL LIMBS WERE DEPLOYED. THE FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22693040 ↗
• InjuryJul 31, 2025Adverse 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). THE ANEURYSM DIAMETER WAS 47MM PRE-OPERATIVELY. DURING THIS INITIAL PROCEDURE, THE MAIN BODY WAS PLACED VIA THE RIGHT APPROACH, CANNULATION WAS PERFORMED VIA THE CROSSOVER LUMEN. CONTRALATERAL CANNULATION WAS NOT COMPLETED WITHIN 14 MINUTES OF POLYMER FILL. ONE OVATION IX LIMB WAS PLACED ON THE CONTRALATERAL SIDE AND TWO OVATION IX LIMBS WERE PLACED ON THE IPSILATERAL SIDE. AFTER TOUCH UP THE ANGIOGRAPHY CONFIRMED NO ENDOLEAKS AND THE PROCEDURE WAS COMPLETED. FOLLOW-UPS WERE CARRIED OUT ON (B)(6) 2022 AND (B)(6) 2023. THE ANEURYSM DIAMETER REMAINED 45MM DURING THIS PERIOD, AND NO ENDOLEAKS WERE CONFIRMED. ON (B)(6) 2025, DURING A FOLLOW-UP, THE ANEURYSM DIAMETER WAS 50MM, AND AN ANEURYSM ENLARGEMENT OF OVER 5MM WAS CONFIRMED. THERE WERE NO ENDOLEAKS OR MIGRATION, AND THE PATIENT WAS PLACED UNDER OBSERVATION. IT WAS DECIDED THAT NO FURTHER INTERVENTION WAS REQUIRED AT THIS TIME, AND A FOLLOW-UP WOULD BE CARRIED OUT IN 6 MONTHS.

  Patient problems: Aneurysm

  MAUDE report 22674341 ↗
• InjuryMay 5, 2025Device Stenosis; Device Stenosis

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. IT WAS REPORTED THAT A BLISTER FORMED WITHIN THE ALTO MAIN BODY AND OCCLUDED THE LIMB; HOWEVER, IT WAS STILL PATENT AND THERE WAS BLOOD FLOW THROUGH IT. THE PHYSICIAN BALLOONED THE GRAFT AND ADDED A VIABAHN (NON-ENDOLOGIX) STENT TO OPEN THE GRAFT AND MOVE IT UP MORE. THIS HELPED OPEN THE LIMB A BIT MORE, BUT IT WAS STILL PARTIALLY OCCLUDED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Stenosis

  MAUDE report 21963955 ↗
• InjuryApr 23, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON (B)(6) 2018. THE PATIENT UNDERWENT REPAIR OF A TYPE II ENDOLEAK (NON-DEVICE RELATED) IN 2019 (EXACT DATE UNKNOWN). IT WAS REPORTED ON (B)(6) 2022 THAT ANEURYSM ENLARGEMENT WITH NO ENDOLEAK WAS IDENTIFIED. AT REINTERVENTION ON (B)(6) 2022, IT WAS IDENTIFIED THAT THE AFX VELA SUPRARENAL HAD MIGRATED APPROXIMATELY 15MM. CLINICAL ASSESSMENT OF THIS EVENT DETERMINED A TYPE IA ENDOLEAK WAS ALSO PRESENT. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. (PREVIOUSLY REPORTED UNDER MFR# 2031527-2022-00123). ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT OF THE DEVICE ON (B)(6) 2025 DUE TO AN ENDOLEAK (INDETERMINATE ORIGIN). THE PATIENT IS REPORTED TO BE STABLE AND IN ICU.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21892732 ↗
• InjuryMar 26, 2025Filling Problem; Failure to Advance; Filling Problem; Failure to Advance

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE LENGTH OF THE PROXIMAL NECK WAS 8MM. CALCIFICATION WAS OBSERVED IN THE PROXIMAL NECK, BILATERAL COMMON ILIAC ARTERIES (CIA), AND EXTERNAL ILIAC ARTERIES (EIA). IT WAS NOTED THAT AN EGOIST (NON-ENDOLOGIX) STANDARD STIFF WIRE WAS USED AND A DRYSEAL (NON-ENDOLOGIX) 16 FR SHEATH WHICH WAS INSERTED THROUGH THE LEFT FEMORAL ARTERY. RESISTANCE WAS ENCOUNTERED DUE TO CIA AND EIA CALCIFICATION. IT WAS REPORTED THAT WHEN THE ALTO MAIN BODY DELIVERY SYSTEM WAS BEING INSERTED, SIGNIFICANT RESISTANCE WAS ENCOUNTERED IN THE AREA WHERE THE TIP COMES OUT FROM THE DRYSEAL SHEATH; THEREFORE, THE ALTO DELIVERY SYSTEM WAS REMOVED. THE DRYSEAL SHEATH WAS ADVANCED CLOSER TO THE RENAL ARTERIES, AND THE ALTO DELIVERY SYSTEM WAS REINSERTED AND ADVANCED CLOSE TO THE RENAL ARTERIES. THE ALTO STENT WAS DEPLOYED, AND AN ATTEMPT WAS MADE TO INJECT THE POLYMER; HOWEVER, THE STENT GRAFT COULD NOT BE FILLED. THE DELIVERY SYSTEM WAS MOVED SLIGHTLY PROXIMALLY, AND POLYMER WAS ABLE TO BE INJECTED INTO THE IPSILATERAL LEG. THE DELIVERY SYSTEM WAS MOVED UP AND DOWN, AND THE POLYMER ROUTE WAS CHECKED FOR KIN

  Patient problems: Clinical Endoleak

  MAUDE report 21698904 ↗
• DeathNov 13, 2024Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. IT WAS REPORTED ON (B)(6) 2024, THAT THE ALTO GRAFT SYSTEM HAD OCCLUDED AND LIMB ISCHEMIA. REINTERVENTION WAS COMPLETED ON (B)(6) 2024 WITH THE IMPLANT OF TWO (2) OVATION IX ILIAC LIMBS AND THE OCCLUSION APPEARED TO BE TREATED SUCCESSFULLY. HOWEVER, THE LIMB RE-OCCLUDED AS AFTER THE RIGHT COMMON FEMORAL ARTERY (CFA) WAS CLOSED, THERE WAS NO DOPPLER SIGNAL. AN ANGIOGRAM FROM THE LEFT CONFIRMED AN OCCLUDED RIGHT LIMB. THE SURGEON THEN PROCEEDED TO DO A FEM-FEM BYPASS FROM THE LEFT EXTERNAL ILIAC TO THE RIGHT EXTERNAL ILIAC; HOWEVER, UPON FINISHING THE FEM-FEM BYPASS, THE LEFT LIMB HAD OCCLUDED. AN AXILLARY BI-FEM BYPASS WAS THEN PERFORMED, WHICH ALSO OCCLUDED. THE PATIENT WAS TAKEN TO THE ICU WHERE LABS WERE RUN, AND THE PATIENT WAS DIAGNOSED WITH HEPARIN INDUCED THROMBOCYTOPENIA WHICH LIKELY CONTRIBUTED TO THE GRAFT OCCLUDING. REINTERVENTION OF ANOTHER AXILLARY BI-FEM BYPASS WAS ATTEMPTED THE FOLLOWING MORNING. THE PATIENT EXPIRED IN THE HOSPITAL ON APPROXIMATELY 27 OCTOBER 2024.

  Patient problems: Ischemia; Obstruction/Occlusion

  MAUDE report 20674168 ↗
• InjuryNov 8, 2024Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2023. IT WAS REPORTED THAT DURING THE CASE THE FLUOROSCOPY REVEALED THAT THE STENT MARKER WAS MISALIGNED PROMPTING THE DELIVERY SYSTEM TO BE ROTATED. THE PHYSICIAN ROTATED THE DELIVERY SYSTEM WHILE THE ENTIRE SHEATH AND ALTO STENT GRAFT SYSTEM SHOULD BE ROTATED AS ONE UNIT WHICH RESULTED IN RESISTANCE. IT IS POSSIBLE THAT THE ALTO MAIN BODY GOT TWISTED AT THIS TIME. THE ALTO MAIN BODY WAS DEPLOYED, AND THE POLYMER INJECTION WAS COMMENCED, THE POLYMER WAS NOT BEING INJECTED INTO THE STENT GRAFT. THE DELIVERY SYSTEM WAS THEN SUBJECTED TO A SERIES OF PUSHING AND PULLING MOTIONS, RESULTING IN THE INJECTION OF THE SEALING AND SUPPORT RINGS. WHEN THE PROCEDURE REACHED THE FOURTH RING IN THE CONTRALATERAL LEG, THE POLYMER STOPPED FILLING. THE PHYSICIAN ELECTED TO IMPLANT THE CONTRALATERAL LIMB WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT AN ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641228 ↗
• InjuryOct 2, 2024Obstruction of Flow; Malposition of Device; Patient-Device Incompatibility; Obstruction of Flow; Malposition of Device; Patient-Device Incompatibility

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. IT WAS REPORTED THAT THE PHYSICIAN HAD TO EXTEND FROM THE MAIN BODY BIFURCATION UP TO THE SECONDARY RING WITH I-CAST (NON-ENDOLOGIX) STENTS DUE TO APPROXIMATELY A 90 DEGREE ANGLE LIMITING FLOW INTO THE LEFT ILIAC LIMB. THE PHYSICIAN EXTENDED PROXIMAL WITH BILATERAL 10X38MM I-CAST STENTS AFTER VERIFYING THAT THE PROXIMAL SEAL WAS INTACT AND A PALMAZ (NON-ENDOLOGIX) STENT WAS NOT REQUIRED. THE ORIGIN OF THE LEFT HYPOGASTRIC ARTERY WAS POORLY VISUALIZED IN THE COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) AND THE LEFT HYPOGASTRIC ARTERY WAS INADVERTENTLY COVERED; HOWEVER, THE PHYSICIAN WAS NOT CONCERNED ABOUT THIS BECAUSE THE RIGHT HYPOGASTRIC ARTERY WAS LARGER. THE PHYSICIAN WAS SATISFIED WITH THE RESULTS OF THE PROCEDURE AND THE PATIENT HAD EQUAL PULSES BILATERALLY IN THE COMMON FEMORAL ARTERIES AND IN THE FEET. IT WAS NOTED THAT THE PATIENT WAS DOING WELL THE NEXT DAY AFTER THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20351457 ↗
• MalfunctionSep 24, 2024Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF AN ALTO STENT GRAFT SYSTEM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE GRAFT WAS INSERTED VIA THE LEFT GROIN, POSITIONED ANTERIORLY, AND CONNECTED TO THE POLYMER. THE PHYSICIAN REPOSITIONED THE STIFF WIRE TO HELP THE GRAFT SETTLE MORE NATURALLY, BUT UNDER FLUOROSCOPY, ONLY THE IPSILATERAL GATE RINGS FILLED, WHILE THE CONTRALATERAL GATE RING, SEALING RING, AND SUPPORT RING DID NOT. ATTEMPTS TO ADJUST THE GRAFT WITH SLIGHT PRESSURE RESULTED IN MINIMAL FILLING OF THE SEALING AND SUPPORT RINGS, BUT THE CONTRALATERAL GATE RINGS REMAINED UNFILLED. AFTER THE 14-MINUTE POLYMER SET TIMER, THE SEALING RING WAS BALLOONED, AND BOTH LIMBS WERE PLACED, FOLLOWED BY BALLOONING WITH 10X40 BALLOONS. A (NON-ENDOLOGIX) 3110 PALMAZ STENT WAS DEPLOYED TO ACHIEVE A SEAL. THE PROCEDURE WAS COMPLETED WITHOUT ANY ENDOLEAKS, AND THE PATIENT REMAINED STABLE, LATER BEING TRANSFERRED TO THE ICU FOR MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296432 ↗
• MalfunctionJun 19, 2024Filling Problem; Filling Problem

  THE PATIENT WAS TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2024, WITH THE IMPLANTATION OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. INITIALLY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED ON BOTH EXTERNAL ILIAC ARTERIES (EIA). THE ALTO DEVICE WAS INSERTED FROM THE LEFT ACCESS AND DEPLOYED. DURING POLYMER INJECTION, THE POLYMER FAILED TO FILL, EVEN IN THE IPSILATERAL RINGS. ATTEMPTS TO RESOLVE THIS INCLUDED RE-CONNECTING THE AUTOINJECTOR AND REMOVING THE GREEN CAP FROM THE SYRINGE, BUT THESE EFFORTS WERE UNSUCCESSFUL. THE SYRINGE AND AUTOINJECTOR WERE REPLACED, BUT THE ISSUE PERSISTED. FINALLY, AFTER MOVING THE DELIVERY SYSTEM UP AND DOWN, THE POLYMER FILLED THE RINGS. THE LIMBS WERE THEN IMPLANTED, AND THE OPERATION WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PATIENT¿S STATUS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19568180 ↗
• InjuryJun 7, 2024Difficult to Advance; Difficult to Advance

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES IN DELIVERING THE DEVICE. IT WAS REPORTED THAT THE PRESSURE FROM THE ADVANCED DEVICE CAUSED AN ILIAC ARTERY RUPTURE. THE RUPTURE WAS SUBSEQUENTLY STENTED AND REPAIRED USING A GORE VIABAHN (NON-ENDOLOGIX) STENT. THE AAA WAS SUCCESSFULLY TREATED, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Rupture

  MAUDE report 19489853 ↗
• InjuryMay 24, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2022 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2024 IDENTIFIED A TYPE 1A ENDOLEAK AND ANEURYSM ENLARGEMENT SIGNIFIED BY SAC GROWTH OF 1.5 CM. THE PHYSICIAN IS PLANNING A SECONDARY INTERVENTION WITH A PALMAZ (NON-ENDOLOGIX) STENT, HOWEVER SECONDARY HAS NOT BEEN SCHEDULED AT THIS TIME. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19394841 ↗
• InjuryMar 25, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; 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). IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF CARDIAC RUPTURE WHICH WAS THE RESULT OF A CARDIAC INFARCTION IN (B)(6) 2023 WHICH REQUIRED A SURGICAL PROCEDURE AT THE TIME AND A PERICARDIAL PATCH WAS USED. THERE WAS NO TREATMENT DONE ON THE CORONARY ARTERIES. IT WAS REPORTED THAT PRIOR TO THE ALTO PROCEDURE, THE RIGHT INTERNAL ILIAC, SUPERIOR AND INFERIOR GLUTEAL ARTERIES WERE OCCLUDED BY COILS. THE INFERIOR MESENTERIC ARTERY (IMA) AND A LUMBAR ARTERY WERE ALSO OCCLUDED. THIS PART OF THE PROCEDURE TOOK FIVE (5) HOURS. THE ALTO MAIN BODY WAS INSERTED VIA THE LEFT ACCESS AND DEPLOYED AND THE POLYMER WAS INJECTED. THE PATIENT'S BLOOD PRESSURE WAS NORMAL AT THIS POINT. THE CONTRALATERAL GATE CANNULATION WAS NOT COMPLETED AFTER 14 MINUTES; THEREFORE, BALLOONING WAS DONE FIRST. THE CONTRALATERAL GATE WAS SUCCESSFULLY CANNULATED AFTER THE BALLOONING, AND AN OVATION IX ILIAC LIMB WAS IMPLANTED. AN ADDITIONAL OVATION IX ILIAC LIMB WAS ADDED AND AT THIS POINT THE ANESTHESIOLOGIST POINTED OUT THERE WAS BLOOD PRESSURE DROP OF APPROXIMATELY AROUND 50BPM. THERE WERE NO PROCEDURE RELATED COMP

  Patient problems: Cardiac Arrest

  MAUDE report 18970864 ↗
• InjuryMar 22, 2024Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE PATIENT HAD A SHORT AORTIC NECK MEASURING APPROXIMATELY 10MM, WITH THE LEFT RENAL ARTERY BEING A COUPLE OF MILLIMETERS LOWER THAN THE RIGHT. THERE WAS BOTH THROMBUS AND CALCIUM AT THE LEVELS OF BOTH RENALS. THE PROCEDURE WENT WELL AND NO ENDOLEAKS WERE NOTICED; HOWEVER, THE LEFT RENAL WAS BARELY VISIBLE. THE PHYSICIAN TOOK A SIMMONS 2 (NON-ENDOLOGIX) CATHETER UP AND GOT A PICTURE OF THE LEFT RENAL AT THE END OF THE PROCEDURE AND LEFT THE CASE CONFIDENT THAT ALL WAS WELL. IT WAS REPORTED THAT THE NEXT DAY THE PATIENT HAD STOPPED MAKING URINE. AN ULTRASOUND WAS TAKEN AND SHOWED THERE WAS NO FLOW IN BOTH RENALS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS NOT TAKEN BECAUSE THE PATIENTS¿ CREATININE HAD ALSO RISEN. THE PHYSICIAN STATED THERE WAS CLOT IN BOTH RENALS, AND THAT THE LEFT WAS SLIGHTLY WORSE THAN THE RIGHT. IT IS UNKNOWN IF THE STENT GRAFT HAD COVERED THE RENALS AS THE PHYSICIAN HAD NOT LOOKED. IT WAS NOTED THAT WITH THE MANIPULATION OF THE GRAFT, ALONG WITH THE CALCIUM AND THROMBUS, THERE WERE FLOW COMPROMISED. THE PHYSICIAN ELECTED TO PERFORM BYPASS

  Patient problems: Obstruction/Occlusion; Respiratory Failure

  MAUDE report 18958293 ↗
• InjuryJan 24, 2024Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024. REPORTEDLY THIS WAS AN OFF LABEL CASE AS THE NON CONIC SHAPE DIAMETER GROWTH IS 12.8% AND SHOULD BE = 10%. AND THE MAX ILIAC DIAMETER MEASURED AT 7.5MM AND SHOULD BE = 8MM AND = 25MM. THE ALTO MAIN BODY SEALING RING WAS PLACED OVER THE LEFT RENAL AND A GORE (NON-ENDOLOGIX) VBX 5X29 MM STENT WAS PLACED TO CREATE A CHIMNEY. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF THE OVATION IX ILIAC LIMBS. A SMALL TYPE IA ENDOLEAK WAS SEEN AT THE END OF THE PROCEDURE. THE PATIENT WILL BE MONITORED AND A 30 DAY FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) WILL BE PERFORMED SEE IF THE TYPE IA ENDOLEAK RESOLVES. ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTING THAT THE FOLLOW UP CTA SHOWED THAT THE INTRAOPERATIVE TYPE IA ENDOLEAK HAS RESOLVED.

  Patient problems: Clinical Endoleak

  MAUDE report 18572254 ↗
• InjuryJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH THE ALTO STENT GRAFT SYSTEM. THE PATIENT HAD A SHORT OFF LABEL NECK WITH A SEVERE ANGLE, MAKING THEM UNSUITABLE FOR A Z-FEN PROCEDURE. DESPITE CHALLENGES IN IMAGING AND DEVICE DEPLOYMENT DUE TO THE NECK'S ANGLE, THE PROCEDURE WAS SUCCESSFUL IN SEALING THE ANEURYSM. A POST-PROCEDURE ISSUE AROSE AS THE LEFT RENAL WAS LOST, POSSIBLY DUE TO THE MIGRATION OF THE RING OR INACCURACIES IN MARKING. THE PATIENT IS STABLE, AND THE CASE OUTCOME, WHILE SUCCESSFUL IN SEALING THE ANEURYSM, RESULTED IN THE LOSS OF THE LEFT KIDNEY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18557053 ↗
• InjuryDec 21, 2023Material Puncture/Hole; Patient-Device Incompatibility; Material Puncture/Hole; Patient-Device Incompatibility

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. A RECENT FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED AN ENDOLEAK AROUND THE SUPPORT RING OF ALTO BODY; HOWEVER, THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED. A TYPE 2 ENDOLEAK (NON-DEVICE RELATED) OR A TYPE 3B ENDOLEAK WAS SUSPECTED AND IT WAS DETERMINED THE ENDOLEAK WAS NOT A TYPE 1A. ON (B)(6)2023 THE ENDOLEAK WAS OBSERVED ON ECHOCARDIOGRAPHY AND BLOOD FLOW FROM THE DEVICE WAS CONFIRMED. THE PHYSICIAN SUSPECTS A TYPE 3B ENDOLEAK AND DID NOT RULE OUT A TYPE 2 ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18370998 ↗
• InjuryDec 13, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA WAS INTENTIONALLY OCCLUDED. AFTER IMPLANT OF THE ALTO MAIN BODY THERE WAS NO TYPE 1A ENDOLEAK NOTED. THE CONTRALATERAL LIMB WAS IMPLANTED ON THE RIGHT SIDE. DURING INSERTION OF THE IPSILATERAL ILIAC LIMB ON THE LEFT SIDE, THE ALTO MAIN BODY MOVED SLIGHTLY; HOWEVER, THE PHYSICIAN CONTINUED THE IMPLANT OF THE LIMB FOLLOWED BY AN ILIAC EXTENSION ON THE RIGHT SIDE. AN INDETERMINATE ENDOLEAK WAS OBSERVED AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT NOT TO PERFORM ANY FURTHER TREATMENT AT THAT TIME. REFERENCE MFR # 3008011247-2023-00198 FOR THIS EVENT. APPROXIMATELY THREE OR FOUR DAYS POST INITIAL PROCEDURE A CONTRAST COMPUTED TOMOGRAPHY (CT) WAS TAKEN PRIOR TO PATIENT DISCHARGE AND SHOWED LEFT LIMB STENOSIS AROUND THE TERMINAL AORTA. AN EMERGENCY INTERVENTION WAS PERFORMED AT THAT TIME AND A BARE STENT WAS IMPLANTED ON THE LEFT LIMB. REFERENCE MFR # 3008011247-2023-00199 FOR THIS EVENT. IT WAS REPORTED THAT THE SIX (6) MONTH FOLLOW-UP CONTRAST CT SHOWED A POSSIBLE TYPE 1A ENDOLEAK. THE PATIENT WAS ADMITTED TO THE H

  Patient problems: Clinical Endoleak

  MAUDE report 18316708 ↗
• InjuryDec 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL PROCEDURE, THE INFERIOR MESENTERIC ARTERY (IMA WAS INTENTIONALLY OCCLUDED. AFTER IMPLANT OF THE ALTO MAIN BODY THERE WAS NO TYPE 1A ENDOLEAK NOTED. THE CONTRALATERAL LIMB WAS IMPLANTED ON THE RIGHT SIDE. DURING INSERTION OF THE IPSILATERAL ILIAC LIMB ON THE LEFT SIDE, THE ALTO MAIN BODY MOVED SLIGHTLY; HOWEVER, THE PHYSICIAN CONTINUED THE IMPLANT OF THE LIMB FOLLOWED BY AN ILIAC EXTENSION ON THE RIGHT SIDE. AN INDETERMINATE ENDOLEAK WAS OBSERVED AND THE PHYSICIAN DECIDED TO MONITOR THE PATIENT NOT TO PERFORM ANY FURTHER TREATMENT AT THAT TIME. APPROXIMATELY THREE OR FOUR DAYS POST INITIAL PROCEDURE A CONTRAST COMPUTED TOMOGRAPHY (CT) WAS TAKEN PRIOR TO PATIENT DISCHARGE AND SHOWED LEFT LIMB STENOSIS AROUND THE TERMINAL AORTA. AN EMERGENCY INTERVENTION WAS PERFORMED AT THAT TIME AND A BARE STENT WAS IMPLANTED ON THE LEFT LIMB. REFERENCE MFR # 3008011247-2023-00199 FOR THIS EVENT.IT WAS REPORTED THAT THE SIX (6) MONTH FOLLOW-UP CONTRAST CT SHOWED A POSSIBLE TYPE 1A ENDOLEAK. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2023 FOR ADDITIONAL EVALUATION AND T

  Patient problems: Clinical Endoleak

  MAUDE report 18312684 ↗
• InjuryNov 16, 2023Off-Label Use; Patient-Device Incompatibility; Material Deformation; Off-Label Use; Patient-Device Incompatibility; Material Deformation

  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 PATIENT'S ANATOMY HAVING TWO (2) 90 DEGREE BENDS IN THE AORTIC NECK. IT WAS REPORTED THAT THE STENT GRAFT POLYMER RING DID NOT LAND AS INTENDED AND AFTER BALLOONING THE RING FOR A MINUTE, THERE WAS A TYPE 1A ENDOLEAK. AN ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN DECIDED IT WAS NOT NECESSARY TO IMPLANT THE ILIAC LIMBS AND THIS WOULD NOT HELP RESOLVE THE ENDOLEAK. THE PATIENT WAS REPORTED AS DOING FINE AFTER THE ENDOVASCULAR PROCEDURE. THE PHYSICIAN ALSO DECIDED TO PERFORM AN OPEN SURGICAL REPAIR THE NEXT DAY POST IMPLANT; HOWEVER, IT IS UNKNOWN IF THAT WAS DONE.

  Patient problems: Clinical Endoleak

  MAUDE report 18154175 ↗
• InjuryNov 9, 2023Lack of Effect; Lack of Effect

  THE PATIENT UNDERWENT INITIAL TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) THROUGH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM. APPROXIMATELY THIRTY (30) DAYS POST THE INITIAL PROCEDURE, AN ENDOLEAK TYPE IA WAS DETECTED DURING THE 30-DAY FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SCAN. THE PHYSICIAN IS PRESENTLY EVALUATING THE POTENTIAL NEED FOR RE-INTERVENTION. THE PATIENT'S CURRENT MEDICAL STATUS IS DOCUMENTED AS STABLE. ADDITIONAL INFORMATION: FOLLOWING A THOROUGH CLINICAL ASSESSMENT, NOTABLE EVIDENCE EMERGED POINTING TOWARDS A 12MM SAC GROWTH AND THE PRESENCE OF A TYPE II ENDOLEAK (NON¿DEVICE RELATED) IN THE LUMBAR ARTERY. THIS DISCOVERY WAS DONE ON (B)(6) 2023, WHILE REVIEWING THE CT (COMPUTED TOMOGRAPHY) SCAN DATED (B)(6) 2023.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18104185 ↗
• InjurySep 11, 2023Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE (5) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH RENAL FAILURE AND RAPID ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER). SUBSEQUENT ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) NON-ENDOLOGIX 4010 PALMAZ STENT ON (B)(6) 2023. WHILE THE TYPE IA ENDOLEAK WAS REPORTEDLY IMPROVED, IT WAS NOT RESOLVED, AND THEREFORE THE ANEURYSM WAS NOT SUCCESSFULLY EXCLUDED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION AND DISCHARGED.

  Patient problems: Aneurysm; Clinical Endoleak; Renal Failure

  MAUDE report 17719734 ↗

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