Ovation iX Abdominal Stent Graft System Aortic Body (REF TV-AB2680-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI M701TVAB2680J1), received between Nov 23, 2015 and Apr 5, 2024 — classified as 4 deaths, 83 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (25 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 87 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2024Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WAS REPORTED. A REVIEW OF COMPUTED TOMOGRAPHY (CT) SCANS SHOWED A SLIGHT ENDOLEAK OUTSIDE THE SEAL LOCATION. ADDITIONALLY, THE CT SHOWED THERE IS CONTRAST AROUND THE LEFT LIMB; HOWEVER, THE SOURCE CANNOT BE LOCATED. THERE IS ALSO A PATENT INFERIOR MESENTERIC ARTERY (IMA). THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19048912 ↗
• InjuryJan 5, 2023Appropriate Device Problem Term/Code Not Available; Lack of Effect; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT IS REPORTEDLY IN GOOD CONDITION, AND THE PHYSICIAN IS EXPLORING TREATMENT OPTIONS.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 16101464 ↗
• InjuryMay 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM AND AN PALMAZ (NON-ENDOLOGIX) STENT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED VIA COMPUTERIZED TOMOGRAPHY. REINTERVENTION IS TO BE SCHEDULED. PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 14325342 ↗
• InjuryJan 10, 2022Off-Label Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX AAA STENT GRAFT SYSTEM. APPROXIMATELY THREE AND A HALF (3.5) POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH BELLY PAIN. AFTER A REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN, IT WAS DETERMINED THE PATIENT HAD AN ANEURYSM ENLARGEMENT AS WELL AS A TYPE 1A ENDOLEAK. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO IMPLANT A BX STENT (NON-ENDOLOGIX) DEVICE. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT INDICATING THAT A NON-ENDOLOGIX DEVICE WAS IMPLANTED DURING THE INITIAL IMPLANT PROCEDURE ON (B)(6) 2018; THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE OVATION IX SYSTEM PER IFU.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13215299 ↗
• InjurySep 7, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (1) ONE YEAR AFTER POST INITIAL PROCEDURE, THE PATIENT WAS PRESENT IN THE HOSPITAL WITH AN AORTIC OCCLUSION. A RE-INTERVENTION WAS DONE AND THE PHYSICIAN ELECTED TO DO AN AXILLARY FEMORAL BYPASS. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING THE SECONDARY PROCEDURE. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST BILATERAL LIMB ISCHEMIA OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE LIMB ISCHEMIA WAS DISCOVERED DURING REVIEW OF THE EMERGENCY ROOM NOTE AND THE OPERATIVE NOTES.

  Patient problems: Failure of Implant; Ischemia; Renal Failure

  MAUDE report 12436984 ↗
• InjuryJun 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PATIENT WILL CONTINUE TO BE MONITORED AND IS REPORTEDLY STABLE. UPDATED INFORMATION AN INTERVENTION IS BEING DISCUSSED BY THE PHYSICIAN BUT SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 12071917 ↗
• InjuryMar 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL IMPLANT DURING A ROUTINE FOLLOW-UP, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN ENDOLEAK OF INDETERMINATE ORIGIN. THE PATIENT WAS REPORTED AS BEING STABLE AND AN INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 11507604 ↗
• InjuryJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THIS INITIAL A PROCEDURE, A POSSIBLE TYPE 1A ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ (NON- ENDOLOGIX) STENT PROACTIVELY. THIS EVENT WAS PREVIOUSLY REPORTED UNDER (MDR # 300811247-2019-00110). NOW, APPROXIMATELY 1.5 YEARS POST INITIAL PROCEDURE, A TYPE 1A ENDOLEAK WAS OBSERVED DURING ROUTINE FOLLOW UP. PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 11159014 ↗
• InjurySep 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL IMPLANT, A TYPE 1A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW UP. THE PATIENT IS STABLE AND PENDING RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 10478250 ↗
• InjuryAug 11, 2020Device-Device Incompatibility; Separation Problem; Device-Device Incompatibility; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THERE WERE AN ADDITIONAL TWO GORE (NON-ENDOLOGIX) ILIAC LIMBS IMPLANTED (OFF LABEL USE OF CONCOMITANT DEVICES). APPROXIMATELY 2 YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH A CONTAINED RUPTURE. ADDITIONALLY, THERE WAS A TYPE 3A ENDOLEAK WITH SEPARATION BETWEEN THE OVATION IX ILIAC LIMB AND THE GORE (NON-ENDOLOGIX) ILIAC LIMB. AN ATTEMPT WAS MADE TO RELINE THE OVATION IX WITH AN ENDURANT (NON-ENDOLOGIX) STENT GRAFT; HOWEVER, THIS WAS ABANDONED DUE TO COMPRESSION OF THE GRAFT AND COVERAGE OF BOTH RENALS. EXPLORATORY LAPAROTOMY WAS PERFORMED WITH REMOVAL OF THE ENDURANT STENT GRAFT AS WELL AS THE OVATION IX WITH RESIDUAL LEFT ILIAC LIMB LEFT IN THE LEFT COMMON ILIAC ARTERY. AORTIC THROMBOSIS WAS ALSO REMOVED. REPORTEDLY, ONLY THE GORE (NON-ENDOLOGIX) WAS LEFT. OPEN REPAIR OF THE RUPTURED AAA WAS COMPLETED WITH PLACEMENT OF A 22MM AORTIC TUBE GRAFT. PATIENT IS REPORTED TO HAVE BEEN DISCHARGED HOME ON DIALYSIS AND WELL.

  Patient problems: Aneurysm; Blood Loss; Failure of Implant; Rupture; Thrombosis

  MAUDE report 10394041 ↗
• InjuryAug 5, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. UPON POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED (EVIDENCE OF A POLYMER LEAK). THE PATIENT EXPERIENCED HYPOTENSION WITH BRADYCARDIAI, AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE REMAINDER OF THE CASE WAS COMPLETED WITHOUT INCIDENT AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED AT THE COMPLETION OF THE CASE. THE PATIENT WAS REPORTED STABLE AND DOING FINE AT THE COMPLETION OF THE CASE.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 10370436 ↗
• InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS EXPERIENCING CLAUDICATION (PAIN IN THE LEGS). AN ANGIOGRAM IDENTIFIED STENOSIS (NARROWING WITHIN THE MAIN BODY OF THE STENT). THE PHYSICIAN SUCCESSFULLY PLACED NON - ENDOLOGIX STENTS AND RESOLVED THE STENOSIS. THE PATIENTS PULSES IN THE LEGS IMPROVED AND IS RECOVERING WELL.

  Patient problems: Stenosis

  MAUDE report 10184631 ↗
• InjuryApr 8, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE CASE CONCLUDED WITHOUT ADDITIONAL NEGATIVE PATIENT SEQUELAE AND THE ANEURYSM WAS EXCLUDED. THE PATIENT WAS REPORTED AS STABLE AND WILL CONTINUED TO BE MONITORED.

  Patient problems: Failure of Implant; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension

  MAUDE report 9935517 ↗
• InjuryFeb 5, 2020Malposition of Device; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL IMPLANT PROCEDURE, THE PROXIMAL MARKERS OF THE MAIN BODY WERE DEPLOYED SLIGHTLY LOW OF THE TARGET LANDING ZONE AT THE LEFT RENAL OSTIUM. UPON CONCLUSION OF THE PROCEDURE, THE FINAL IMAGING DETECTED A TYPE IA ENDOLEAK AROUND THE RENALS ON THE PATIENT'S RIGHT SIDE. THE PHYSICIAN ELECTED TO TREAT THE INTRAOPERATIVE ENDOLEAK BY ADDITIONALLY IMPLANTING A PALMAZ STENT, AFTER WHICH THE MAJORITY OF THE LEAK DISAPPEARED. THE PATIENT WAS REPORTEDLY STABLE WHEN LEAVING THE OPERATING ROOM. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT AND BELIEVES THE ENDOLEAK WILL SELF-RESOLVE WITHIN A MONTH OF THE PROCEDURE. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9673017 ↗
• InjuryJan 16, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 9599315 ↗
• InjuryJan 16, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT AND A PALMAZ (NON-ENDOLOGIX) STENT; THIS CONSTITUTES AN OFF-LABEL INITIAL CASE DUE TO USE WITH AN ADJUNCTIVE DEVICE. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN OVATION IX MAIN BODY AND ILIAC LIMB ON (B)(6) 2019; THIS IS ALSO AN OFF-LABEL PROCEDURE DUE TO USE OF AFX WITH OVATION IX DEVICES. THIS ACUTE EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 2031527-2019-00266. IN ADDITION AND DURING THE RE-INTERVENTION PROCEDURE IN (B)(6) 2019, THE PATIENT EXPERIENCED HYPOTENSION AND ANAPHYLAXIS POST POLYMER FILL OF THE OVATION IX MAIN BODY. THE PATIENT WAS SUCCESSFULLY TREATED FOR THE ANAPHYLACTIC REACTION PER DEVICE IFU, AFTER WHICH THE PATIENT STABILIZED. THE RE-INTERVENTION WAS REPORTED TO HAVE TAKEN APPROXIMATELY EIGHT (8) HOURS TO COMPLETE, WHICH IS CONSIDERED A PROLONGED PROCEDURE. THIS INTRAOPERATIVE EVENT WAS PREVIOUSLY REPORTED PER MFR. REPORT # 3008011247-2019-00094. ANOTHER FIVE (5) MONTHS POST RE-INTERVENTION (SOMETIME IN (B)(6) 2019), THE PATIEN

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9599107 ↗
• InjuryJan 7, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. POST EXTERNALIZED CROSSOVER WIRE, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. AT THE CONCLUSION OF THE PROCEDURE, THE ANEURYSM WAS CONFIRMED SUCCESSFULLY EXCLUDED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 9559190 ↗
• InjuryOct 3, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE AORTIC BODY FILL CHANNELS APPEARED FILLED. AT THE CONCLUSION OF THE PROCEDURE THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 9151637 ↗
• InjurySep 19, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AN INTRAOPERATIVE TYPE IA ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO BALLOON AT THE LEVEL OF THE SEALING RINGS HOWEVER, THE ENDOLEAK REMAINED. A DECISION WAS MADE TO CONCLUDE THE CASE AND CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 9092657 ↗
• InjurySep 19, 2019Component Incompatible; Off-Label Use; Difficult to Advance; Component Incompatible; Off-Label Use; Difficult to Advance

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCEMENT OF THE AORTIC BODY DELIVERY SYSTEM THROUGH THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN ELECTED TO IMPLANT A BES AT THE PROXIMAL LEFT COMMON ILIAC ARTERY BELOW THE AORTIC BIFURCATION. THE AORTIC BOY DELIVERY SYSTEM WAS TRACKED THROUGH THE BES DEVICE HOWEVER, THE BES WAS DISLODGED AND DISPLACED UPWARD ON THE AORTIC BODY DELIVERY SHEATH. THE PHYSICIAN UNSHEATHED THE AORTIC BODY STENT GRAFT, THE BES LODGED ON THE DISTAL PORTION OF THE AB. POLYMER FILL WAS COMPLETED HOWEVER, THE CONTRALATERAL LIMB COULD NOT BE VISUALIZED. A DECISION WAS MADE TO IMPLANT A BARD COVERED STENT AT THE PROXIMAL EDGE OF THE IPSILATERAL LIMB. AT THE CONCLUSION OF THE CASE, AN INTRA-OPERATIVE TYPE I ENDOLEAK WAS PRESENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 9092332 ↗
• InjuryAug 27, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. THE AORTIC MAIN BODY LANDED AND DEPLOYED AS EXPECTED. POLYMER MIX AND FILL COMPLETED AS EXPECTED. THE FINAL RUN REVEALED A TYPE IA ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO BALLOON AT THE LEVEL OF THE SEALING RINGS HOWEVER, THE ENDOLEAK REMAINED. A DECISION WAS MADE TO CONCLUDE THE CASE AND MONITOR THE PATIENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8938194 ↗
• InjuryJul 16, 2019Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. DURING THE PROCEDURE, THE GRAFT DID NOT DEPLOY AS EXPECTED. AFTER POSITIONING OF THE GRAFT THE CROWN APPEARED FULLY DEPLOYED HOWEVER THE BOTTOM APPEARED CONSTRAINED. THE PIGTAIL WAS USED TO RELEASE THE COMPRESSION OPEN. THE ANEURYSM WAS EXCLUDED WITH SUCCESSFUL SEAL HOWEVER, THE GRAFT WAS NOTED TO LAND LOWER THAN EXPECTED. THE PROCEDURE CONCLUDED WITHOUT INCIDENT. THE PATIENT WAS REPORTED IN GOOD CONDITION AND WILL CONTINUE TO BE MONITORED. THERE WAS NO NEGATIVE PATIENT SEQUELAE AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8796461 ↗
• InjuryJul 12, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE CASE CONCLUDED WITHOUT ADDITIONAL NEGATIVE PATIENT SEQUELAE AND THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 8785163 ↗
• InjuryJul 12, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE A POSSIBLE TYPE IA ENDOLEAK WAS OBSERVED HOWEVER, THERE WERE VISUALIZATION DIFFICULTIES. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT GRAFT PROACTIVELY. THE POST ANGIOGRAM APPEARED SIMILAR WITH CONTINUED VISUALIZATION ISSUES. THE PHYSICIAN CONCLUDED THE CASE AND PLANS TO FOLLOW-UP DURING ROUTINE SURVEILLANCE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 8784902 ↗
• InjuryJun 19, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, A POLYMER LEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT GRAFT AND BALLOON AT THE LEVEL OF THE SEALING RINGS TO RESOLVE A TYPE IA ENDOLEAK, HOWEVER THE ENDOLEAK REMAINED. THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Aneurysm; Failure of Implant; Low Blood Pressure/ Hypotension

  MAUDE report 8714381 ↗

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