Ovation iX Abdominal Stent Graft System Aortic Body (REF TV-AB3480-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI M701TVAB3480J1), received between Nov 23, 2015 and Nov 22, 2024 — classified as 11 deaths, 91 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 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 105 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN ALTO STENT GRAFT SYSTEM FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017. APPROXIMATELY SEVEN (7) YEARS AFTER THE INITIAL PROCEDURE, NON-SYMPTOMATIC SAC ENLARGEMENT, WITH A SUSPECTED TYPE II ENDOLEAK WAS IDENTIFIED. THE SAC MEASURED AT 9CM IN 2017, IN 2023 IT MEASURED AT 5.3CM, AND THE MOST RECENT COMPUTED TOMOGRAPHY MEASURED IT AT 6.3CM. ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2024, CONFIRMING THE TYPE II ENDOLEAKS AT THE INFERIOR MESENTERIC ARTERY (IMA) AND LUMBARS. REPORTEDLY, THE OVATION IX MAIN BODY RINGS WERE MISSHAPED. A PALMAZ (NON-ENDOLOGIX) STENT WAS IMPLANTED TO ENSURE PROPER WALL APPOSITION AND ADEQUATE INTERNAL RING LUMEN. HE ALSO DECIDED TO EXTEND THE LEFT COMMON ILIAC ARTERY LIMB TO THE LEFT HYPO BECAUSE THE LIMB HAD LANDED IN THROMBUS DURING THE INITIAL IMPLANT. THE PATIENT WAS REPORTED TO BE DISCHARGED ONE DAY POST-REINTERVENTION AND IS TO BE REFERRED TO INTERVENTIONAL RADIOLOGIST TO EMBOLIZE THE IMA.

  Patient problems: Aneurysm

  MAUDE report 20759080 ↗
• InjuryMay 24, 2024Patient-Device Incompatibility; Lack of Effect; Patient-Device Incompatibility; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM ON (B)(6) 2017. ROUTINE FOLLOW-UP ON (B)(6) 2024 IDENTIFIED TYPE IA ENDOLEAK AND SAC GROWTH. REINTERVENTION HAS NOT YET BEEN PLANNED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 19394614 ↗
• InjuryJan 9, 2024Deformation Due to Compressive Stress; Insufficient Device Problem Information; Device Stenosis; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Device Stenosis

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2018. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING ROUTINE FOLLOW UP THE PHYSICIAN SCHEDULED A REINTERVENTION ON (B)(6) 2024 FOR AN UNKNOWN REASON. THE PATIENT IS CURRENTLY BEING MONITORED. ADDITIONAL INFORMATION: INTERVENTION HAS BEEN COMPLETED. TWO OVATION IX ILIAC EXTENDERS HAVE BEEN IMPLANTED.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18475980 ↗
• DeathDec 6, 2023Device-Device Incompatibility; Lack of Effect; Device-Device Incompatibility; Lack of Effect

  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. AT THE CONCLUSION OF THE PROCEDURE THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 300811247-2019-00166. NOW, APPROXIMATELY FOUR (4) YEARS POST IMPLANT THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS. THE PHYSICIAN STATED THE SEALING RINGS WERE WELL OPPOSED TO THE AORTIC WALL. THERE WAS NO TYPE 1A OR TYPE 2 ENDOLEAK AND NO UNORGANIZED OR FRESH BLOOD IN THE ANEURYSM SAC; HOWEVER, THE COMMON ILIAC ARTERIES (CIA) WERE ANEURYSMAL AND THE PATIENT HAD A GORE (NON-ENDOLOGIX) ILIAC BRANCH ENDOPROSTHESIS (IBE) PLACED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. THE PHYSICIAN ATTRIBUTED THE SAC ENLARGEMENT TO SAC WALL DETERIORATION. AFTER THIS EXPLANT PROCEDURE, THE PATIENT WAS DISCHARGED OUT OF THE INTENSIVE CARE UNIT (ICU) AND IS RECOVERING. THE EXPLANTED STENT GRAFT IS NOT AVAILABLE FOR RETURN.

  Patient problems: Aneurysm

  MAUDE report 18276290 ↗
• InjuryJul 28, 2023Lack of Effect; 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 AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A PALMAZ (NON-ENDOLOGIX) STENT AND UTILIZING A TRUE (NON-ENDOLOGIX) BALLOON ON (B)(6) 2023. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED. ADDITIONAL INFORMATION: INTERNAL CLINICAL ASSESSMENT IDENTIFIED THAT SIGNIFICANT ANEURYSM ENLARGEMENT WAS NOTED PER OPERATIVE REPORT AND CT (COMPUTED TOMOGRAPHY) SCAN AT FOUR (4) DAYS POST SECONDARY INTERVENTION WITH A RECURRING TYPE IA ENDOLEAK (RELATED TO INADEQUATE TREATMENT WITH THE PALMAZ (NON-ENDOLOGIX) STENT AND BALLOONING ON (B)(6) 2023). THE PHYSICIAN ELECTED TO FURTHER TREAT THE PATIENT BY IMPLANTING A NON-ENDOLOGIX FENESTRATED GRAFT ON (B)(6) 2023; THIS TERTIARY INTERVENTION RESULTED IN OCCLUSION OF THE RIGHT RENAL ARTERY, WHICH THEN CAUSED ACUTE KIDNEY INJURY (AKI). THE PATIENT WAS READMITTED ON (B)(6) 2023 FOR TREATMENT OF CONGESTIVE HEART FAILURE (CHF) RELATED TO THE ACUTE KIDNEY FAILURE WHICH STEMMED FROM THE (B)(6) 20

  Patient problems: Aneurysm; Clinical Endoleak; Renal Failure

  MAUDE report 17416125 ↗
• InjuryFeb 16, 2023Lack of Effect; 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 AND A HALF (5.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AND (NON-DEVICE-RELATED) TYPE II ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PATIENT IS REPORTEDLY IN GOOD CONDITION. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Clinical Endoleak

  MAUDE report 16391089 ↗
• InjuryOct 14, 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, TWO (2) OVATION IX ILIAC LIMBS, AND OVATION PRIME FILL POLYMER. APPROXIMATELY TWO (2) YEARS POST-INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP THE PATIENT WAS IDENTIFIED WITH A TYPE IA ENDOLEAK AND A TYPE 2 ENDOLEAK (NON-DEVICE RELATED). A DATE FOR A RE-INTERVENTION HAS NOT YET BEEN SET.

  Patient problems: Failure of Implant

  MAUDE report 15611715 ↗
• InjuryAug 11, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE THE GRAFT WAS DIFFICULT TO DEMATE, THE IMPLANT WAS DISPLACED AND THERE WAS TYPE 1A ENDOLEAK. THIS PATIENT WAS NOT IN ROUTINE FOLLOW-UP CARE. NOW, APPROXIMATELY SIX YEARS POST IMPLANT THE PHYSICIAN REPORTED THAT THE AAA RUPTURED FROM A TYPE 1 ENDOLEAK. UPON FURTHER REVIEW IT APPEARS THERE WAS A JUXTARENAL ANEURYSM THAT MAY HAVE CAUSED THE RUPTURE AS THERE WAS NO VISIBLE TYPE 1A ENDOLEAK AND THE ISSUE APPEARS TO BE WHERE THAT PROXIMAL CROWN IS ABOVE THE OVATION IX FABRIC. THE PHYSICIAN ELECTED TO IMPLANT A COOK PMEG (PHYSICIAN MODIFIED ENDOGRAFT) (NON-ENDOLOGIX) STENT TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST THIS SECONDARY PROCEDURE.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 15207323 ↗
• InjuryJul 18, 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 IMPLANT OF THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK. THE PATIENT IS REPORTEDLY IN STABLE CONDITION, AND RE-INTERVENTION IS CURRENTLY NOT PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 15043147 ↗
• InjuryJun 20, 2022Use of Device Problem; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; 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 STENT GRAFT SYSTEM (ONE (1) OVATION IX MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE II ENDOLEAK (NON-DEVICE RELATED) WAS IDENTIFIED. THIS WAS TREATED WITH THE IMPLANT OF AN OVATION IX ILIAC LIMB AND AN OVATION IX EXTENDER. APPROXIMATELY ONE AND A HALF YEARS (1.5) POST-SECONDARY, A TYPE IA ENDOLEAK WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION WAS COMPLETED WITH THE IMPLANT OF A COOK MEDICAL (NON-ENDOLOGIX) ZFEN STENT-GRAFT (REPORTED UNDER MFR# 3008011247-2018-00154). NOW, APPROXIMATELY FOUR (4) YEARS POST-TERTIARY, A TYPE IA ENDOLEAK, A TYPE IIIA (LEFT RENAL FEN) ENDOLEAK, AND A POSSIBLE TYPE IIIA ENDOLEAK BETWEEN THE OVATION IX MAIN BODY AND COOK MEDICAL (NON-ENDOLOGIX) ZFEN WAS IDENTIFIED AT ROUTINE FOLLOW-UP. THE LEFT RENAL WAS EXTENDED WITH A NON-ENDOLOGIX I-CAST STENT BEYOND THE LEFT RENAL FEN, AND THE STENT WAS FLARED. ACCESS BETWEEN THE OVATION IX MAIN BODY AND THE ZFEN WAS OBTAINED, AND THE TYPE IIIA ENDOLEAK WAS COILED. THE OVERLAP BETWEEN THE OVATION IX MAIN BODY AND THE ZFEN WAS INCREASED WITH THE IMPLANT OF AN OVA

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14748358 ↗
• DeathApr 6, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND HALF (5.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED AT THE HOSPITAL WITH ABDOMINAL PAIN AND A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM A SECONDARY PROCEDURE AND IMPLANTED A PALMAZ (NON-ENDOLOGIX) STENT; HOWEVER THIS DID NOT RESOLVE THE ENDOLEAK. THE PHYSICIAN ALSO EXTENDED THE ILIAC LIMBS BILATERALLY WITH 14X140 GORE (NON-ENDOLOGIX) LIMBS TO RAISE THE AORTIC BIFURCATION. THESE ENDOVASCULAR INTERVENTIONS ALSO DID NOT RESOLVE THE ENDOLEAK. THE FAMILY DECLINED THE OPEN REPAIR OPTION AND THE PATIENT EXPIRED THE NEXT DAY AFTER THE SECONDARY INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 14025233 ↗
• InjuryFeb 14, 2022Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THERE WAS STENT GRAFT MIGRATION, A TYPE 1A ENDOLEAK AND ANEURYSM ENLARGEMENT NOTED. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN ALTO STENT GRAFT SYSTEM TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL POST SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Embolism/Embolus; Failure of Implant; Ischemia; Stroke/CVA

  MAUDE report 13529897 ↗
• InjuryDec 2, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Improper or Incorrect Procedure or Method; 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. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED A RIGHT HYPOGASTRIC ARTERY ANEURYSM. THE PHYSICIAN INTENDS TO PERFORM REINTERVENTION; HOWEVER, THIS HAS NOT YET BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT REINTERVENTION WAS COMPLETED BY EXTENDING THE LEFT COMMON ILIAC DUE TO POTENTIAL LIMB THROMBOSIS WITH A 22X120 OVATION IX ILIAC LIMB AND COVERED THE RIGHT HYPOGASTRIC ANEURYSM AND EXTENDED WITH A 10X160 OVATION IX ILIAC LIMB. REPORTEDLY, THE PATIENT DID WELL AND BOTH LIMBS ARE PATENT. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IA ENDOLEAK OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE IA ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE 28-MONTH POST IMPLANT CT SCAN.

  Patient problems: Aneurysm; Failure of Implant; Thrombosis/Thrombus

  MAUDE report 12917509 ↗
• InjuryNov 10, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; 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. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED A TYPE IA ENDOLEAK AND A TYPE II ENDOLEAK (NON-DEVICE RELATED). ADDITIONALLY, THERE WAS PATENT LEFT ACCESSORY RENAL NOTED COMING IN DIRECTLY AT THE LEVEL OF THE SEALING RING, A PATENT LUMBAR COMING IN JUST ABOVE THE SEALING RING, AND A PAIR ABOVE THE BIFURCATION OF THE AORTIC BODY OF THE DEVICE. THE PHYSICIAN INTENDS TO PERFORM REINTERVENTION; HOWEVER, THIS HAS NOT YET BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Failure of Implant

  MAUDE report 12788703 ↗
• InjuryNov 2, 2021Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; 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 AND TWO (2) OVATION IX ILIAC LIMBS. IT WAS ALSO REPORTED THAT A PALMAZ (NON-ENDOLOGIX) STENT WAS IMPLANTED AT AN UNKNOWN TIME FOR AN UNKNOWN REASON. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE IT WAS IDENTIFIED THAT THE SEALING RING IS IN THE SAC OF THE ANEURYSM, THERE IS ANEURYSM ENLARGEMENT AND A TYPE IA ENDOLEAK. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12734336 ↗
• InjuryJul 23, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH THE ALTO STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE 1A ENDOLEAK. THE PATIENT REFUSED FURTHER TREATMENT AND IS STABLE. CORRECTION: THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A TYPE 1A ENDOLEAK. THE PATIENT REFUSED FURTHER TREATMENT AND IS STABLE. ADDITIONAL INFORMATION: DURING THE INTERNAL CLINICAL ASSESSMENT IT WAS DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 6MM OCCURRED. THE SAC GROWTH WAS DISCOVERED DURING REVIEW OF THE 46 MONTH POST IMPLANT CT SCAN.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12222230 ↗
• InjuryApr 26, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE INITIAL IMPLANT WAS OUTSIDE THE INDICATIONS OF USE DUE TO A LARGE NECK DIAMETER AND PRE-EXISTING THROMBUS. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, A TYPE 1A ENDOEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE SECONDARY PROCEDURE WAS DONE, COILS WERE PLACED AND THE ENDOLEAK APPEARED TO BE RESOLVED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER (MDR # 2031527-2020-00188). NOW APPROXIMATELY, ONE (1) YEAR POST-RE-INTERVENTION, A FOLLOW-UP CT (COMPUTED TOMOGRAPHY) SCAN, ANOTHER TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. CORRECTION AND ADDITIONAL INFORMATION: THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE INITIAL IMPLANT WAS OUTSIDE THE INDICATIONS OF USE DUE TO A LARGE NECK DIAMETER AND PRE-EXISTING THROMBUS. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, A TYPE 1A ENDOEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE SECONDARY PROCEDURE

  Patient problems: Failure of Implant

  MAUDE report 11728638 ↗
• InjuryOct 7, 2020Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information; Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX MAIN BODY AND TWO (2) ILIAC LIMB STENT GRAFTS TO TREAT A PRE-OPERATIVELY CONTAINED RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) DAYS POST INITIAL PROCEDURE THERE WAS A TYPE IA ENDOLEAK THE PHYSICIAN ELECTED TO PLACE A PALMAZ STENT AND BALLOONED IT. APPROXIMATELY ELEVEN (11) DAYS POST INITIAL PROCEDURE A FOLLOW UP COMPUTED TOMOGRAPHY (CT) WAS DONE AND THE TYPE IA ENDOLEAK WAS STILL PRESENT. THE INTERVENTIONAL RADIOLOGIST PUT IN COILS AND GLUE. IT IS UNKNOWN IF THE ENDOLEAK WAS RESOLVED. THE PATIENT IS STABLE. NOTE: THE PRE-EXISTING RUPTURED AAA IS CAUTIONARY PRODUCT USE. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT MULTIPLE TYPE II ENDOLEAKS (NON-DEVICE-RELATED FAILURE) AND INVAGINATION OF THE POLYMER RING WERE ALSO PRESENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10646236 ↗
• InjuryOct 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX MAIN BODY AND TWO (2) ILIAC LIMB STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE A TYPE 1A ENDOLEAK WAS FOUND ON THE 30 DAY FOLLOW UP. THE PATIENT IS STABLE AND THE PHYSICIAN PLANS TO RE-INTERVENE

  Patient problems: Failure of Implant

  MAUDE report 10614062 ↗
• DeathAug 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). A TYPE 1A ENDOLOEAK WAS IDENTIFIED POST INITIAL PROCEDURE. THE PHYSICIAN ELECTED NOT TO TREAT THE PATIENT AT THE TIME. THE PATIENT WILL BE MONITORED AND A 30- DAY POST OP CT (COMPUTED TOMOGRAPHY) WILL BE PERFORMED TO DETERMINE IF THE TYPE 1A ENDOLEAK REMAINS OR HAS RESOLVED. PATIENT IN PENDING POSSIBLE RE-LINE. ADDITIONAL INFORMATION: THIS PATIENT PASSED AWAY WHICH WAS NOT REPORTED IN THE INITIAL REPORT. THE DEATH WAS DISCOVERED DURING A REVIEW OF THE DISCHARGE SUMMARY.

  Patient problems: Death; Failure of Implant

  MAUDE report 10474316 ↗
• DeathMay 12, 2020Use of Device Problem; Device-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Device-Device Incompatibility; Insufficient Device Problem Information

  DURING THE INITIAL IMPLANTATION OF THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA), THE NOSE CONE OF THE OVATION IX ABDOMINAL STENT GRAFT DELIVERY SYSTEM BECAME DETACHED AND WAS LEFT INSIDE THE PATIENT. IT WAS REPORTED THAT THE NOSE CONE BECOME TRAPPED BEHIND THE PALMAZ (NON - ENDOLGOIX) BARE METAL STENT. RETRIEVAL WAS ATTEMPTED AND DURING THAT MANEUVER THE NOSE CONE BECAME DETACHED. THE PATIENTS ACCESS SITES WERE CLOSED AFTER THE FINAL ANGIOGRAMS SHOWED NO LEAKS. THE PATIENT WAS REMOVED FROM THE EXAM TABLE AFTER ANESTHESIA EXTUBATED AND WAS IN TRANSPORT TO THE ICU WHEN THE TRANSPORT TEAM RETURNED. THE PATIENT WAS PLACED BACK ON THE EXAM TABLE AND ACCESS WAS RE-OBTAINED. AN ANGIOGRAM REVEALED NO EXTRAVASATION AND A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A SMALL TEAR IN THE AORTA. THE PATIENT WAS SLIGHTLY HYPOTENSIVE, BUT WAS RESPONDING TO TREATMENT. THE ENDOLOGIX REPRESENTATIVE WAS INFORMED BY THE PHYSICIAN THAT THE PATIENT EXPIRED POST OP DAY TWO (2). THE PHYSICIAN STATED THAT THE PATIENT'S BLOOD PRESSURE BECAME UNSTABLE AND THE PATIENT FIBRILLATED BUT THE EXACT CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 10048066 ↗
• InjuryMar 23, 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 PATIENT RECOVERED AND THE CASE CONTINUED. A POSSIBLE TYPE IA ENDOLEAK WAS ALSO IDENTIFIED POST PROCEDURE. THE PATIENT WILL CONTINUE TO BE MONITORED.

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

  MAUDE report 9869213 ↗
• InjuryMar 10, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. IT WAS NOTED THAT THE INITIAL IMPLANT WAS OUTSIDE THE INDICATIONS OF USE DUE TO A LARGE NECK DIAMETER AND PRE-EXISTING THROMBUS. APPROXIMATELY TWO (2) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IA ENDOLEAK AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN PLANS TO RE-INTERVENE AND WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9812537 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY EIGHT (8) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK, INSIGNIFICANT ANEURYSM ENLARGEMENT (3MM TO 5MM), AND A TYPE IA ENDOLEAK. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9777673 ↗
• InjuryFeb 25, 2020Insufficient 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. DURING THE INITIAL IMPLANT PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ STENT AND BALLOON, HOWEVER, THE ENDOLEAK WAS PERSISTENT. THE PATIENT WAS REPORTEDLY STABLE WHEN LEAVING THE OPERATING ROOM AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9751697 ↗

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