Alto™ Abdominal Stent Graft System TV-AB3480-N (UDI 00850007370916)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00850007370916), received between May 26, 2021 and Sep 25, 2026 — classified as 6 deaths, 43 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Filling Problem” (8 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.

• InjurySep 25, 2026Off-Label Use

  The patient was implanted with the Alto Abdominal Stent Graft system to treat an abdominal aortic aneurysm (AAA) on (b)(6) 2026. During this initial procedure, a type IA endoleak was identified and treated with a Palmaz stent (non-Endologix). It was reported that the case was borderline on-label, the patient was not an open surgical candidate, and had no other treatment options. The patient was reported as doing fine, was expected to be discharged one day post-op, and scheduled for a 30-day follow-up. After the initial report, clinical assessment determined that the type IA endoleak was not resolved by the Palmaz stent; however, it is unknown if the 30-day follow-up was performed to determine if the endoleak ultimately resolved.

  Patient problems: Clinical Endoleak

  MAUDE report 50897181 ↗
• InjuryMar 19, 2026Migration

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM WITH A RIGHT RENAL CHIMNEY STENT (NON ENDOLOGIX) ON (B)(6) 2024 FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THIRTY DAYS POST PROCEDURE, THE RIGHT RENAL STENT BECAME OCCLUDED. THE PATIENT WAS ADMITTED, AND THE RIGHT RENAL CHIMNEY WAS ACCESSED FROM THE GROIN, FOLLOWED BY PERCUTANEOUS MECHANICAL THROMBECTOMY. THE CHIMNEY STENT (NON ENDOLOGIX) WAS SUBSEQUENTLY EXTENDED DISTALLY. DUE TO PROCEDURAL MANIPULATION, THE ALTO MAIN BODY SHIFTED, RESULTING IN A TYPE IA ENDOLEAK IDENTIFIED ON THE FINAL ANGIOGRAM. THE PATIENT WAS DISCHARGED GIVEN THE HIGH CONTRAST LOAD AND THE TEMPORARY PERIOD OF RENAL MALPERFUSION. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AT THE END OF (B)(6) 2026. ON (B)(6) 2026, THE PATIENT UNDERWENT REINTERVENTION. MEDTRONIC ENDURANT AORTIC CUFF (NON ENDOLOGIX), A RIGHT RENAL PERISCOPE STENT (NON ENDOLOGIX), A LEFT RENAL CHIMNEY STENT (NON ENDOLOGIX), AND COIL EMBOLIZATION OF THE ANEURYSM SAC (NON ENDOLOGIX) WERE PLACED. THE TYPE IA ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE PATIENT HAS REMAINED ASYMPTOMATIC THROUGHOUT THE COURSE OF TREATMENT, WITH THE EXCEPTION OF THE INITIAL RENAL STENT OCCLUSION. FOLLOWI

  Patient problems: Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 24645817 ↗
• InjuryFeb 25, 2026Filling Problem; Improper or Incorrect Procedure or Method

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2026. DURING THE PROCEDURE, THE CONTRALATERAL LIMB DID NOT FULLY FILL WITH POLYMER. THE PHYSICIAN ATTEMPTED TO PUSH AND PULL ON THE HANDLE (OFF LABEL USE), BUT THE POLYMER WOULD NOT ADVANCE. THE PHYSICIAN THEN TRIED PUTTING A LITTLE EXTRA PRESSURE ON THE SYRINGE (OFF LABEL USE), BUT IT CAUSED THE RINGS TO DELAMINATE. A KELLY CLAMP WAS PLACED ON THE POLYMER TO ENSURE THAT POLYMER WOULDN¿T BE INJECTED INTO THE PATIENT IF THERE WAS AN OPENING. ANESTHESIOLOGIST WAS NOTIFIED IN CASE THERE WAS ANAPHYLACTIC REACTION. THE PHYSICIAN USED THE CROSSOVER LUMEN TO PLACE THE CONTRALATERAL LIMB. BALLOONING OF THE RINGS WAS DONE WITH LIGHT PRESSURE. THE REST OF THE PROCEDURE WENT WELL WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC STENT GRAFT SYSTEM. THERE WERE NO ADVERSE PATIENT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443953 ↗
• DeathFeb 24, 2026Positioning Failure; Filling Problem; Off-Label Use; Short Fill

  THE PATIENT WAS BEING TREATED WITH ENDOVASCULAR REPAIR SINCE THEY WEREN'T A SURGICAL CANDIDATE DURING AN OFF-LABEL CASE ON (B)(6) 2026 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM IN COMPLEX ANATOMY. REPORTEDLY THE PATIENT HAD PREVIOUS (NON-ENDOLOGIX) ILIAC STENTS GRAFTS PLACED IN BOTH COMMON ILIACS APPROXIMATELY TEN-ELEVEN (10-11) YEARS PRIOR THAT EXTENDED INTO THE AORTA BUT STOPPED ABOUT 77MM FROM THE RIGHT RENAL ARTERY. THE PHYSICIANS PARTIALLY DEPLOYED THE ALTO MAIN BODY STENT GRAFT ABOVE THE LANDING ZONE, ADVANCED A WIRE INTO THE CONTRALATERAL LIMB LUMEN, THEN SNARED AND EXTERNALIZED THE WIRE INTO THE CONTRALATERAL ACCESS. THE DEVICE SUCCESSFULLY LANDED AT THE DESIRED LOCATION. THE IPSILATERAL LIMB AND THE RINGS FILLED (WITH POLYMER), BUT THE CONTRALATERAL LIMB DIDN¿T. THE CASE CONTINUED BY EXTENDING INTO THE COMMON ILIACS JUST SHORT OF THE HYPOGASTRIC ARTERIES ON BOTH SIDES WITH THE OVATION IX ILIAC STENT GRAFT LIMBS. DURING THE DEPLOYMENT OF THE CONTRALATERAL LIMB, IT LANDED BELOW THE THIRD HALF RING IN THE ALTO MAIN BODY LIMB. AFTER BALLOONING THE LIMBS AN ANGIOGRAPHY WAS OBTAINED THAT SHOWED A TYPE IA ENDOLEAK AND A RUPTURED RIGHT COMMON ILIAC ARTERY AROUND THE

  Patient problems: Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture; Shock

  MAUDE report 24434605 ↗
• InjuryFeb 10, 2026Malposition of Device; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AFTER THE STENT-GRAFT WAS DEPLOYED, A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN FELT THERE WERE VERY LIMITED OPTIONS FOR REPAIRING INTRAOPERATIVELY TYPE 1A ENDOLEAK DUE TO LENGTH FROM RENAL TO TOP OF LIMBS BEING LESS THAN 45MM, AND PHYSICIAN DID NOT WANT TO PALMAZ DUE TO OTHER SURGICAL AND ENDO OPTIONS. THE PATIENT IS BEING MONITORED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE INTRAOPERATIVE TYPE IA ENDOLEAK HAS NOT BEEN RESOLVED AND IT IS UNKNOWN IF FURTHER INTERVENTION WILL BE PERFORMED. THE PATIENT IS CURRENTLY DOING FINE. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 3008011247-2021-00081. ADDITIONAL INFORMATION: IT WAS REPORTED THAT CURRENTLY THE STENT GRAFT WAS FOUND TO HAVE SETTLED INTO THE REVERSE TAPER NECK COMING DOWN LOWER THAN INTENDED AND THE STENT GRAFT RADIO OPAQUE MARKERS ARE SITTING 5-7MM BELOW THE RENAL WITH THE CENTER OF THE RING SITTING AT 15MM BELOW THE RENAL WHERE THE NECK IS 39MM IN DIAMETER. THE ENDOLEAK APPEARS TO BE ALL ANTERIOR ON CENTERLINE. IT WAS NOTED THAT COILING AROUND THE RING COULD BE ATTEMPTED IF AN OPEN REPAIR IS NOT A FEASIBLE OPT

  Patient problems: Aneurysm

  MAUDE report 24308889 ↗
• InjuryDec 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  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. DURING THE PROCEDURE, A POLYMER LEAK WAS EXPERIENCED. APPROXIMATELY FOUR MINUTES AFTER THE POLYMER WAS MIXED, THE PATIENT'S BLOOD PRESSURE BECAME HYPOTENSIVE DROPPING TO 50 BEATS PER MINUTE. AT THAT POINT, THE POLYMER SYRINGE HAD FULLY BOTTOMED OUT. IT IS UNKNOWN WHAT WAS ADMINISTERED; HOWEVER, THE ANESTHESIA TEAM WAS ABLE TO STABILIZE THE PATIENT'S BLOOD PRESSURE. NO ADDITIONAL IMPLANTS WERE REQUIRED, AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23784996 ↗
• InjuryJul 30, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE YEAR LATER, DURING A ROUTINE FOLLOW UP, IT WAS DISCOVERED THAT THERE WAS A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO USE A PALMAZ STENT GRAFT (NON-ENDOLOGIX) TO RESOLVE THE TYPE IA ENDOLEAK. THE FINAL PATIENT STATUS IS UNKNOWN.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22671512 ↗
• InjuryJul 1, 2025Filling Problem; Off-Label Use; Material Twisted/Bent; Filling Problem; Off-Label Use; Material Twisted/Bent

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6)2025, WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. DURING THE PROCEDURE, THE CONTRALATERAL LIMB FAILED TO FILL WITH POLYMER. IT WAS ALSO REPORTED THAT A DELAY IN POLYMER FILL OCCURRED UPON THE CONNECTION OF THE AUTOINJECTOR. DUE TO THESE COMPLICATIONS, THE PHYSICIAN ELECTED TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL FOR EXPLANTATION AND OPEN SURGICAL REPAIR.

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

  MAUDE report 22372101 ↗
• InjuryJun 12, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. APPROXIMATELY TWENTY-EIGHT (28) DAYS AFTER THE INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED. A RE-INTERVENTION WAS DONE ON (B)(6) 2025. THE PHYSICIAN ELECTED TO USE A (NON-ENDOLOGIX) 4010 PALMAZ STENT INSIDE OF THE EXISTING ALTO GRAFT WHICH HELPED ATTAIN PROXIMAL SEAL. THE TYPE IA ENDOLEAK WAS SUCCESSFULLY RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22194540 ↗
• InjuryOct 31, 2024Short Fill; Deformation Due to Compressive Stress; Migration; Short Fill; Deformation Due to Compressive Stress; Migration

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE CONTRALATERAL LIMB OF THE ALTO MAIN BODY DID NOT FILL WITH POLYMER. THE "UP AND OVER" LUMEN WAS USED TO WIRE THE CONTRALATERAL GATE AND SUCCESSFULLY PLACE THE CONTRALATERAL LIMB. ONE DAY LATER THE PATIENT PRESENTED WITH BUTTOCK CLAUDICATION/PAIN AND DIMINISHED PULSES IN THE RIGHT GROIN AND FOOT. THE RIGHT ILIAC WAS FOUND TO HAVE MIGRATED AND KINKED AT THE BIFURCATION OF THE AORTIC BODY. THE PHYSICIAN ELECTED TO IMPLANT 11X59MM VBX (NON-ENDOLOGIX) STENTS BILATERALLY RAISING THE BIFURCATION OF THE AORTIC BODY AND REMEDYING THE PROBLEM.

  Patient problems: Ischemia; Pain

  MAUDE report 20580113 ↗
• InjuryAug 27, 2024Device Stenosis; Device Stenosis

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANTATION OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM ON (B)(6) 2023. APPROXIMATELY ONE MONTH AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A SIGNIFICANT KINK IN THE UNSUPPORTED AREA OF THE CONTRALATERAL GATE OF THE MAIN BODY. ON (B)(6) 2023, A RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN OPTED FOR THE IMPLANTATION OF A BES (BIOABSORBABLE EVEROLIMUS-ELUTING STENT), USING A 9X39MM STENT ON THE LEFT AND A 10X39MM STENT ON THE RIGHT. POSTERIOR TIBIAL ARTERY (PTA) EXAMINATION REVEALED NO STENOSIS AFTER STENT PLACEMENT. THE LEFT COMMON FEMORAL ARTERY (LCFA) AND POSTERIOR SUPERFICIAL ARTERY (PSA) WERE OVERSEWN USING A CONTINUOUS RUNNING SUTURE. THE FINAL ANGIOGRAPHY DEMONSTRATED NO STENOSIS, INDICATING GOOD FLOW. A COMPREHENSIVE CLINICAL EVALUATION WAS ALSO CONDUCTED, REVEALING EVIDENCE OF STENOSIS IN THE PROXIMAL LEFT COMMON ILIAC ARTERY AND THE OCCURRENCE OF A TYPE II ENDOLEAK (ANATOMY-RELATED), INVOLVING THE LUMBAR AND INFERIOR MESENTERIC ARTERIES. THESE CONDITIONS WERE IDENTIFIED DURING A THOROUGH EXAMINATION OF THE COMPUTED TOMOGRAPHY (CT) SCAN. (MFR# 3008011247-2023-00179) ON JULY

  Patient problems: Stenosis

  MAUDE report 20077993 ↗
• InjuryAug 22, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023. APPROXIMATELY ONE (1) YEAR POST INDEX PROCEDURE FOLLOW-UP A COMPUTED TOMOGRAPHY (CT) REVEALED A TYPE IA ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Clinical Endoleak

  MAUDE report 20033941 ↗
• MalfunctionAug 5, 2024Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ON BOTH LEGS, THE ALTO MAIN BODY WAS INSERTED FROM THE RIGHT ACCESS. DURING POLYMER INJECTION, THE POLYMER FILLED VERY SLOWLY. THE POLYMER FILL STOPPED WHILE 10CC STILL REMAINED IN THE SYRINGE. POLYMER WAS OBSERVED IN THE IPSILATERAL 1ST AND 2ND RINGS AND A PART OF SEALING RING; HOWEVER, NO POLYMER WAS APPARENT IN IPSILATERAL 3RD AND 4TH RINGS, SUPPORT RING AND ALL CONTRALATERAL RINGS. BOTH LIMBS WERE THEN IMPLANTED. AN ANGIOGRAPHY WAS TAKEN THAT SHOWED A TYPE IA ENDOLEAK. THE PHYSICIAN DECIDED TO ADD A GORE (NON-ENDOLOGIX) EXCLUDER CUFF TO THE PROXIMAL PORTION OF THE GRAFT. THE TYPE 1A ENDOLEAK WAS RESOLVED INTRAOPERATIVELY, AND THE OPERATION WAS COMPLETED. THE FINAL PATIENT STATUS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19910208 ↗
• InjuryJul 10, 2024Deflation Problem; Inflation Problem; Device Dislodged or Dislocated; Deflation Problem; Inflation Problem; Device Dislodged or Dislocated

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE INTEGRATED BALLOON ON THE ALTO DELIVERY SYSTEM WOULD ONLY PARTIALLY INFLATE AND WOULD NOT EXPAND THE MID-CROWN. THE BALLOON ALSO WOULD NOT DEFLATE WHEN THEY ASPIRATED THE BALLOON WHICH WAS UP DURING THE POLYMER FILL. THE ALTO MAIN BODY DEVICE ENDED UP LANDING HIGHER THAN PLANNED AND THE PHYSICIAN FELT LIKE THIS WAS BECAUSE OF THE INABILITY TO USE THE BALLOON TO EXPAND THE DEVICE BEFORE FIXATING. THERE WAS ALSO A TYPE 1A ENDOLEAK AT 14 MINUTES POST IMPLANT. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ (NON-ENDOLOGIX) STENT; HOWEVER, THE TYPE 1A ENDOLEAK WAS STILL PRESENT. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND DOING WELL AT END OF PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19710460 ↗
• InjuryMay 17, 2024Short Fill; Migration; Short Fill; Migration

  THE PATIENT WAS BEING IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PROCEDURE STARTED AS NORMAL WITH ACCESS, MOVED FORWARD TO FIXATION OF 34MM STENT GRAFT. THE MARKERS WERE PLACED AT THE LOWER LEFT ACCESSORY RENAL, JUST UNDER MID-RENAL ARTERY. FIXATED AND MOVED ON TO POLYMER INJECTION. AFTER MIXING THE POLYMER AND ATTACHING IT TO POLYMER PORT FOLLOWED BY ATTACHING IT TO THE AUTOINJECTOR, THE PHYSICIAN NOTICED POLYMER WAS NOT FILLING THE STENT GRAFT. THE PHYSICIAN GENTLY RETRACTED THE DELIVERY SYSTEM, BUT THE POLYMER STILL DID NOT FILL THE STENT GRAFT. THEN PROCEEDED TO GENTLY PUSH DELIVERY SYSTEM FORWARD AND THE STENT GRAFT STILL DID NOT FILL. THE PHYSICIAN DETACHED THE POLYMER SYRINGE AND AUTOINJECTOR, AND A NEW POLYMER AND AUTOINJECTOR WERE USED. THE POLYMER WAS MIXED AND ATTACHED TO POLYMER PORT ONCE AGAIN, THIS TIME GRAFT FILLED EXTREMELY SLOW. RETRACTED THE LUNDERQUIST (NON-ENDOLOGIX) WIRE TO ALLOW GRAFT TO ORIENTATE TO NATIVE ARTERY AND PROCEEDED TO USE UP AND OVER LUMEN FOR CANNULATION. BALLOONED SEALING RING AT 14 MINUTES 30 SECONDS FOR ONE MINUTE, THEN PLACED LIMBS ON BOTH SIDES. THE FINAL RUN SHOWED A LARGE TYPE 1A ENDOLEAK

  Patient problems: Clinical Endoleak

  MAUDE report 19339191 ↗
• InjuryMay 2, 2024Filling Problem; Filling Problem

  THE PATIENT WAS BEING TREATED FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2024 WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM. THE ALTO ABDOMINAL STENT GRAFT DELIVERY SYSTEM WAS INSERTED FROM THE RIGHT ACCESS. DURING POLYMER INJECTION, POLYMER ONLY PARTIALLY FILLED THE CONTRALATERAL LEG SUPPORT RINGS. THE PHYSICIAN PULLED DOWN THE STIFF WIRE AND JIGGLED THE DELIVERY SYSTEM, BUT IT DID NOT RESOLVE THE PROBLEM. THE CONTRALATERAL CANNULATION WAS ACHIEVED THROUGH THE CROSS OVER LUMEN. AFTER 14 MINUTES, THE POLYMER STILL DID NOT COMPLETELY FILL INTO EITHER OF THE CONTRALATERAL LEG SUPPORT RINGS. THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE AND IMPLANTED LIMBS. PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235182 ↗
• DeathApr 8, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2024, WITH THE IMPLANTATION OF AN ALTO ABDOMINAL AORTIC GRAFT SYSTEM. FOLLOWING THE DEPLOYMENT OF THE ALTO ABDOMINAL AORTIC GRAFT SYSTEM, A FINAL ANGIOGRAPHY REVEALED THE PRESENCE OF A TYPE 1A ENDOLEAK. DESPITE ATTEMPTS TO ADDRESS THIS WITH A COMPLIANT BALLOON, THE LEAK PERSISTED. A (NON-ENDOLOGIX) 22X40MM ATLAS BALLOON WAS EMPLOYED. DURING THE INFLATION OF THE NON-COMPLIANT BALLOON, A RUPTURE OCCURRED. AS A RESULT OF THE RUPTURE, THE PATIENT'S BLOOD PRESSURE DROPPED, NECESSITATING THE PLACEMENT OF AN OCCLUSION BALLOON WHILE INITIATING CHEST COMPRESSIONS. THE PHYSICIAN MADE THE DECISION TO EXPLANT THE ALTO GRAFT AND LIMBS AND OPTED TO PROCEED WITH AN AXILLARY-FEMORAL BYPASS. IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION: THE CLINICAL EVALUATION REVEALS THAT DURING AN ATTEMPT TO RESOLVE THE TYPE IA ENDOLEAK USING INTRAOPERATIVE BALLOONING OF THE NECK, AN AORTIC RUPTURE OCCURRED. THIS INTRAOPERATIVE AORTIC RUPTURE RESULTED IN SURGICAL CONVERSION, MASSIVE INTERNAL BLEEDING, CARDIAC ARREST, AND DETERIORATION OF THE PATIENT'S CONDITION, ULTIMATELY LEADING TO

  Patient problems: Cardiac Arrest; Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Ruptured Aneurysm

  MAUDE report 19068307 ↗
• InjuryMar 21, 2024Filling Problem; Patient-Device Incompatibility; Filling Problem; Patient-Device Incompatibility

  THE PATIENT UNDERWENT TREATMENT FOR A RUPTURE WITH THE IMPLANTATION OF THE ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024. THIS INITIAL PROCEDURE FALLS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) AS STATED IN THE INSTRUCTIONS FOR USE (IFU), DUE TO THE UTILIZATION OF THE ALTO MAIN BODY DEVICE TO ADDRESS A RUPTURE. THE PATIENT PRESENTED WITH CHALLENGING ANATOMICAL FEATURES, INCLUDING AN ANGLED NECK AND AORTA, AS WELL AS AN EXTREMELY TORTUOUS ILIAC. DEPLOYMENT OF THE ALTO MAIN BODY WAS SUCCESSFUL; HOWEVER, DURING POLYMER FILL, THE CONTRALATERAL LIMB FAILED TO FILL. THE ATTENDING PHYSICIAN ENCOUNTERED DIFFICULTY ACCESSING THE LIMB AND SUSPECTED OCCLUSION DUE TO ITS ANGLE. A FEM-FEM PROCEDURE WAS PERFORMED, EFFECTIVELY SEALING THE ABDOMINAL AORTIC ANEURYSM (AAA). POST-PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 18955939 ↗
• MalfunctionNov 6, 2023Short Fill; Short Fill

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL PROXIMAL EXTENSION ON (B)(6) 2011. APPROXIMATELY TWELVE (12) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A DISASSOCIATION OF THE PROXIMAL EXTENSION AND THE BIFURCATED STENT OF THE AFX GRAFT RESULTING IN A TYPE 3A ENDOLEAK. THIS EVENT OCCURRED BEYOND THE EXPECTED LIFE OF THE PRODUCT OF 10 YEARS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN ALTO STENT GRAFT SYSTEM. DURING THIS PROCEDURE IT WAS NOTED THAT THE CONTRALATERAL LIMB OF THE ALTO GRAFT DID NOT FILL WITH POLYMER. THE ¿UP AND OVER¿ LUMEN WAS USED AND THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS REPORTED AS GOOD PRE AND POST IMPLANT. THE DELIVERY SYSTEM WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18075346 ↗
• InjuryNov 1, 2023Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THE PATIENT'S COMMON ILIAC RUPTURED WHILE THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO SNARE THE GUIDEWIRE THROUGH THE CROSSOVER LUMEN, BUT LOST WIRE ACCESS DUE TO RETRACTING THE SHEATH TOO FAR. IN RESPONSE, THE PHYSICIAN CONVERTED TO OPEN REPAIR, AFTER WHICH THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN TREATED THE HYPOTENSION WITH FLUIDS AND EPINEPHRINE, HOWEVER THE PATIENT IS REPORTEDLY IN POOR CONDITION AND NOT PRODUCING URINE OUTPUT POST PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD PRE-EXISTING, HIGH CREATININE LEVELS AND WAS BELIEVED TO ONLY HAVE ONE FUNCTIONING KIDNEY; THIS IS WHY THE PHYSICIAN CHOSE TO NOT INJECT MUCH CONTRAST DURING THE PROCEDURE. THE PATIENT ALSO HAD HEAVY CALCIFIED DISEASE IN THE LEFT, PROXIMAL COMMON ILIAC WITH A SHARP HAIRPIN TURN THAT WAS UNDERAPPRECIATED.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 18052174 ↗
• InjuryOct 27, 2023Deflation Problem; Filling Problem; Inflation Problem; Deflation Problem; Filling Problem; Inflation Problem

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANT OF AN ALTO STENT GRAFT SYSTEM. THE ALTO DELIVERY SYSTEM WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, AND THE MID-CROWN WAS DEPLOYED. THE PHYSICIAN ATTEMPTED TO INFLATE THE INTEGRATED BALLOON, BUT THE CONTRAST SOLUTION WAS INJECTING SMOOTHLY, AND THE BALLOON DID NOT INFLATE AS EXPECTED. THE PHYSICIAN PUSHED THE SYRINGE STRONGLY TO INFLATE THE BALLOON, AND THE DISTAL PORTION OF MID-CROWN EXPANDED. THE BALLOON DEFLATION WAS ALSO DIFFICULT, AND IT TOOK LONGER THAN EXPECTED TO DEFLATE. THE PHYSICIAN INJECTED THE POLYMER, BUT THE CONTRALATERAL LIMB DID NOT FILL. THE ALTO MAIN BODY WAS SLIGHTLY PUSHED UPWARD, AND THE POLYMER WAS SLIGHTLY FILLED INTO THE CONTRALATERAL LIMB. THE INTEGRATED BALLOON WAS AGAIN INFLATED FOR BALLOONING THE SEALING RING BUT WOULD NOT COMPLETELY INFLATE UP TO THE MAXIMUM VOLUME (19CC). THE BALLOON WAS DEFLATED WITH SOME DIFFICULTY AGAIN. ANGIOGRAPHY WAS PERFORMED. THERE WAS NO ENDOLEAK IDENTIFIED. THE CONTRALATERAL AND IPSILATERAL OVATION IX ILIAC LIMBS WERE IMPLANTED. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAKS AND THE OPERATION WAS COMPLETED. THE PATIENT WAS REPORTED

  Patient problems: Failure of Implant

  MAUDE report 18024837 ↗
• InjuryOct 16, 2023Deformation Due to Compressive Stress; Device Stenosis; Deformation Due to Compressive Stress; Device Stenosis

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A "SIGNIFICANT KINK IN THE UNSUPPORTED AREA OF THE CONTRALATERAL GATE OF THE MAIN BODY". THE PHYSICIAN PLANS TO RE-INTERVENE BY ADDITIONAL "STENTING OF [THE] KINKED LIMB" WITH "LEFT COMMON FEMORAL ARTERY PSEUDOANEURYSM REPAIR". NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT.

  Patient problems: Clinical Endoleak; Pseudoaneurysm; Stenosis

  MAUDE report 17946392 ↗
• InjuryOct 16, 2023Filling Problem; Filling Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THE PHYSICIAN NOTICED THAT THE POLYMER FILLED THE SEALING RING, SUPPORT RING AND IPSILATERAL SIDE, BUT NOT THE CONTRALATERAL SIDE. DESPITE THE SYRINGE NOT BEING ENTIRELY EMPTY, THE PATIENT REMAINED STABLE, AND POLYMER LEAKAGE WAS NOT SUSPECTED. ATTEMPTS WERE MADE TO RESOLVE THE ISSUE, BUT THE ALTO DEVICE'S BODY COULD NOT BE PUSHED FURTHE. A CROSS-OVER LUMEN AND GUIDEWIRE WERE USED TO ACCESS THE CONTRALATERAL LEG, BUT DUE TO A LACK OF SUPPORT ON THAT SIDE, THE SNARE DELIVERY CATHETER COULDN'T BE INSERTED. AFTER 14 MINUTES, BALLOONING WAS PERFORMED, AND EVENTUALLY, THE SNARE DELIVERY CATHETER WAS SUCCESSFULLY ADVANCED INTO THE CONTRALATERAL LEG, ALLOWING FOR THE PLACEMENT OF THE FOLLOWING LIMBS. THE PROCEDURE WAS CONCLUDED AND NO INJURY TO THE PATIENT WAS OBSERVED. THE DELIVERY SYSTEM IS UNAVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Failure of Implant

  MAUDE report 17946111 ↗
• DeathJun 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. ELEVEN (11) DAYS POST INITIAL PROCEDURE, THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INITIAL REPORT. NOTE: THIS IS A CLINICAL STUDY PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17203904 ↗
• MalfunctionJun 14, 2023Short Fill; Short Fill

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. DURING THE INITIAL IMPLANT PROCEDURE, THE INJECTED POLYMER ONLY FILLED ONE SIDE AND THE RINGS, LEAVING THE OPPOSITE SIDE UNFILLED. THE PHYSICIAN ATTEMPTED TO RESOLVE THIS ISSUE BY MANIPULATING THE DEVICE BUT WAS UNSUCCESSFUL. ANOTHER ATTEMPT WAS MADE BY CANNULATING THE OPPOSITE GATE AFTER PERFORMING PROXIMAL BALLOONING. THIS TIME, THE CANNULATION WAS SUCCESSFUL, AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ANY OBSERVED ENDOLEAKS. THE IPSILATERAL LIMB WAS IMPLANTED WITHOUT COMPLICATIONS. AN ANGIOGRAPHY LATER REVEALED A TYPE II ENDOLEAK (NON¿DEVICE RELATED FAILURE) FROM THE LUMBAR ARTERY. A KINK IN THE STENT-GRAFT BETWEEN THE SUPPORT RING AND THE FOURTH LEG RING ON THE OPPOSITE SIDE WAS CONFIRMED, POSSIBLY CAUSED BY VESSEL TORTUOSITY. BALLOONING WAS PERFORMED IN THE KINKED AREA, AND THE PRESSURE GRADIENT OF THE RIGHT LIMB SHOWED NO ISSUES. THE PATIENT WAS REPORTEDLY NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125736 ↗

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