Ovation iX Abdominal Stent Graft System Aortic Body (REF TV-AB2980-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI M701TVAB2980J1), received between Oct 28, 2015 and Sep 25, 2026 — classified as 3 deaths, 68 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 72 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Lack of Effect

  The patient was initially treated for an Abdominal Aortic Aneurysm (AAA) on (b)(6) 2019 with the implant of an Alto Abdominal Stent Graft System. Routine follow-up conducted on approximately on (b)(6) 2026 identified a Type IA Endoleak. Patient currently has no symptoms and was being monitored with a re-intervention scheduled; however, the re-intervention procedure was cancelled as the patient¿s family decided not to do anything.

  Patient problems: Clinical Endoleak

  MAUDE report 50899768 ↗
• InjuryJun 26, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON 25 SEPTEMBER 2017 WITH THE IMPLANT OF AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM. A PREVIOUS TYPE II ENDOLEAK WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY ANGIOGRAM DATED (B)(6) 2018 AND DEFERRED TO VASCULAR SURGERY FOR MANAGEMENT. THE TYPE II ENDOLEAK WAS PREVIOUSLY TREATED WITH THE ADDITION OF COILING IN THE SAC AT UNKNOWN TIME AFTER CONSULT WITH VASCULAR SURGERY APPROXIMATELY (B)(6) 2021. AT AN UNKNOWN TIME IN 2023 THERE WAS AN ANEURYSM RUPTURE AND TYPE IIIA ENDOLEAK OF THE RIGHT COMMON ILIAC ARTERY. PATIENT UNDERWENT RELINING WITH (NON-ENDOLOGIX) BILATERAL COMMON ILIAC STENTS AT SOME TIME IN 2023.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 22336603 ↗
• InjuryMay 8, 2024Unintended Movement; Unintended Movement

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF THE WITH THE OVATION IX STENT GRAFT SYSTEM AND AN OVATION IX EXTENDER ON (B)(6) 2017. ON (B)(6)2024, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN AND A CONTAINED RUPTURE. EXAMINATION REVEALED BOTH COMMON ILIAC ARTERIES WERE NOW ANEURYSMAL. BOTH LIMBS MOVED PROXIMALLY AND WERE IN THE INFRARENAL SAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY COILING BOTH HYPOGASTRIC ARTERIES AND IMPLANTING FOUR (4) OVATION IX ILIAC LIMBS.

  Patient problems: Clinical Endoleak; Rupture

  MAUDE report 19272163 ↗
• InjuryAug 10, 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 WITH A PATENT PAIR OF LUMBARS (NON-DEVICE-RELATED TYPE II ENDOLEAKS) FEEDING THE ANEURYSM SAC, EVENTUALLY CREATING A SHORTER AORTIC NECK. THIS LED TO A TYPE IA ENDOLEAK.THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. ADDITIONAL INFORMATION: THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A 28X45 OVATION IX EXTENSION AT THE RENAL SITE TO IMPROVE THE DURABILITY OF THE PROXIMAL SEAL, ALONG WITH A 14X80 OVATION IX ILIAC LIMB ON THE DISTAL LEFT LIMB. A SEAL WAS ESTABLISHED UP TO THE HYPOGASTRIC REGION DUE TO THE SLIGHTLY ECTATIC AND CHALLENGING-TO-ACCESS NATURE OF THE LEFT COMMON ILIAC. IT WAS NOTED THAT THERE WAS NOT INDICATION OF A TYPE IA ENDOLEAK. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED TO HOME ON POSTOPERATIVE DAY ONE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17505242 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX STENT GRAFT SYSTEM ON (B)(6) 2019. ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2023, IDENTIFIED SAC EXPANSION (SIZE OF GROWTH NOT REPORTED) AND POSSIBLE NECK DILATION. REINTERVENTION HAS NOT YET BEEN PLANNED. AFTER THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT THE PATIENT WAS SENT TO CLEVELAND CLINIC AND IT IS UNKNOWN IF TREATMENT WAS PERFORMED.

  Patient problems: Aneurysm

  MAUDE report 17213641 ↗
• InjuryOct 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS BEING IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT THE GRAFT REQUIRED TO BE EXPLANTED DUE TO AN IMPENDING RUPTURE. IT WAS NOTED THAT THE RUPTURE WAS DUE TO WEAKENING AND TEARING OF THE AORTIC WALL CAUSED BY INFECTION. THE GRAFT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT IS DOING WELL. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN/EVALUATION.

  Patient problems: Unspecified Infection; Vascular Dissection

  MAUDE report 15556511 ↗
• InjurySep 30, 2022Fluid/Blood Leak; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Fluid/Blood Leak; Material Integrity Problem; 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 THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A SIGNIFICANT INCREASE IN THE ANEURYSM SAC FROM 5.2CM TO 6CM (GREATER THAN 5MM GROWTH), A TYPE II ENDOLEAK (NON-DEVICE-RELATED) AND A TYPE III ENDOLEAK (OF INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER AAA ENDOPROSTHESIS CUFFS ON 13 AUGUST 2020. AT THE CONCLUSION OF THE SECONDARY PROCEDURE, A SMALL BLUSH OF CONTRAST WAS VISUALIZED. DURING FOLLOW-UP ON 03 SEPTEMBER 2020, A PERSISTENT TYPE III ENDOLEAK WAS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN AND ANGIOGRAM. THE PHYSICIAN ELECTED TO RE-INTERVENE ON 30 OCTOBER 2020 BY IMPLANTING TWO (2) NON-ENDOLOGIX LIMB EXTENSIONS, ONE PER ILIAC/SIDE. AT THE CONCLUSION OF THE TERTIARY PROCEDURE, NO EVIDENCE OF A TYPE III ENDOLEAK WAS VISUALIZED PER CONTRAST AORTOGRAM. DURING FOLLOW-UP ON 16 MARCH 2021 AND 06 OCTOBER 2021, A PERSISTENT TYPE III ENDOLEAK WAS DETECTED PER CT/ANGIOGRAM. THE PHYSICIAN ELECTED TO CONTINUE MONITORING THE PATIENT D

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 15510193 ↗
• InjuryAug 17, 2022Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; 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 THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PATIENT'S CURRENT CONDITION IS UNKNOWN, AND IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE.

  Patient problems: Failure of Implant

  MAUDE report 15246448 ↗
• InjuryJun 29, 2022Obstruction of Flow; Obstruction of Flow

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, ONE OF THE LIMBS WAS FOUND TO HAVE OCCLUDED AND ANOTHER LIMB WAS FOUND KINKED WITH THROMBUS WITHIN THE MAIN BODY. THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE AND WAS DISCHARGED.

  Patient problems: Failure of Implant; Obstruction/Occlusion

  MAUDE report 14862498 ↗
• InjuryApr 19, 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. FOR A FEW YEARS, THE PATIENT WAS LOST TO CONTINUOUS ROUTINE FOLLOW-UPS POST INITIAL IMPLANT. APPROXIMATELY FOUR (4) YEARS POST INITIAL PROCEDURE, THE PATIENT UNDERWENT ROUTINE FOLLOW-UP IN STABLE CONDITION. A COMPUTERIZED TOMOGRAPHY SCAN IDENTIFIED A TYPE IA ENDOLEAK WITH CONTRAST FILLING AROUND THE SEALING RING AND THE AAA INCREASING IN SIZE. THE AORTA BECAME MORE TORTUOUS, CREATING AN ANGLE AND PULLING THE GRAFT. AN ADDITIONAL ANGIOGRAM SHOWED THE GRAFT LOCATION AND PLACEMENT LOOKED STABLE. THE TYPE IA ENDOLEAK WAS SUCCESSFULLY TREATED WITH THE IMPLANT OF A PALMAZ (NON-ENDOLOGIX) 40X10 MM STENT ACROSS THE RADIOPAQUE MARKS OF THE INITIALLY IMPLANTED GRAFT AND SEALING RING, FURTHER EXPANDING THE SEAL UP TOP. POST ANGIOGRAM AGAIN SHOWED NO ENDOLEAK WITH BETTER APPOSITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14144024 ↗
• InjuryJan 4, 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 ABDOMINAL AORTIC ANEURYSM STENT SYSTEM. APPROXIMATELY SEVEN (7) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (AT INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX EXTENDERS AND A PALMAZ STENT ON (B)(6) 2019. THE SEAL WAS REPORTEDLY IMPROVED AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. REFERENCE MFR. REPORT # 3008011247-2019-00047 FOR THIS PREVIOUSLY REPORTED EVENT. APPROXIMATELY TWO (2) YEARS POST-SECONDARY PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE 1B ENDOLEAK (ON RIGHT-SIDE), TYPE II ENDOLEAK (NON-DEVICE-RELATED), AND A PERSISTENT TYPE 1A ENDOLEAK (PREVIOUSLY TREATED WITH A PALMAZ STENT). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX ILIAC LIMBS ON (B)(6) 2021. REFERENCE MFR. REPORT # 3008011247-2021-00043. APPROXIMATELY EIGHT (8) MONTHS POST THIRD PROCEDURE, THE PATIENT PRESENTED WITH AN ANEURYSM ENLARGEMENT, A TYPE 1A, AND 1B ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13155278 ↗
• InjurySep 1, 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 AT ROUTINE FOLLOW-UP WITH AN ENDOLEAK (AT INDETERMINATE ORIGIN) PER CT (COMPUTED TOMOGRAPHY) SCAN. IN ADDITION, A PATENT IMA (INFERIOR MESENTERIC ARTERY) IS FILLING THE ANEURYSM SAC (CLASSIFIED AS A TYPE II ENDOLEAK WITH ANEURYSM ENLARGEMENT (UNKNOWN DIAMETER)). IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. PATIENT IS REPORTEDLY IN GOOD CONDITION. ADDITIONAL INFORMATION: AN INTERNAL CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 1A ENDOLEAK AND TYPE 2 ENDOLEAK (NON-DEVICE-RELATED) OF THE LUMBAR ARTERY.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12408661 ↗
• InjuryMay 18, 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 SEVEN (7) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK (AT INDETERMINATE ORIGIN). THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX EXTENDERS AND A PALMAZ STENT ON (B)(6) 2019. THE SEAL WAS REPORTEDLY IMPROVED AND PATIENT WAS DISCHARGED IN STABLE CONDITION. REFERENCE MFR. REPORT # 3008011247-2019-00047 FOR THIS PREVIOUSLY REPORTED EVENT. NOW ANOTHER TWO (2) YEARS LATER, PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK (ON RIGHT-SIDE), TYPE II ENDOLEAK (NON-DEVICE-RELATED) AND A PERSISTENT TYPE IA ENDOLEAK (PREVIOUSLY TREATED WITH A PALMAZ STENT). THE PHYSICIAN PLANS TO RE-INTERVENE AND THE PATIENT IS REPORTEDLY IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) OVATION IX ILIAC LIMBS ON (B)(6) 2021. THE ENDOLEAKS WERE SUCCESSFULLY RESOLVED AND THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Failure of Implant

  MAUDE report 11846093 ↗
• InjuryDec 5, 2020Improper 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 ABDOMINAL STENT GRAFT SYSTEM (ONE (1) MAIN BODY AND FIVE (5) ILIAC LIMB EXTENSIONS) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST-INITIAL PROCEDURE THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK. THE PATIENT IS PENDING RE-INTERVENTION AND IS BEING MONITORED. ADDITIONAL INFORMATION: A SUCCESSFUL RE-INTERVENTION WAS COMPLETED ON (B)(6) 2020. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX (PALMAZ) BARE METAL STENT AND COIL BEHIND THE TOP OF THE GRAFT TO RESOLVE THE REPORTED TYPE 1A ENDOLEAK. THE PATIENT WAS REPORTED AS DOING GREAT AND WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10950818 ↗
• DeathDec 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 THREE (3) YEARS POST INITIAL PROCEDURE, A DEGRADATION OF THE NECK WAS IDENTIFIED FOLLOWING A COMPUTED TOMOGRAPHY (CT) SCAN. APPROXIMATELY EIGHT (8) MONTHS AFTER THE COMPUTED TOMOGRAPHY (CT) SCAN THE PATIENT PRESENTED WITH A RUPTURE. THE PHYSICIAN REPAIRED THE RUPTURE UTILIZING TWO (2) NON-ENDOLOGIX GORE PROXIMAL EXTENSIONS. THE PATIENT WAS REPORTED AS DOING WELL FOLLOWING THE PROCEDURE. DAYS AFTER THE PROCEDURE IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY. IT IS UNCERTAIN WHAT LEAD TO THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION: THE CLINICAL ASSESSMENT IDENTIFIED A TYPE IA ENDOLEAK.

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 10924827 ↗
• InjuryNov 12, 2020Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 5.5 YEARS POST INITIAL PROCEDURE, THE DEVICE HAS COMPLETELY BROKEN APART (STENT FRACTURE WITH DEVICE SEPARATION) AND SAC GROWTH OF 10CM WAS IDENTIFIED. THE PHYSICIAN COMPLETED A SUCCESSFUL RE-INTERVENTION AND RE-LINED THE EXISTING GRAFTS WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM (OFF-LABEL). THIS EVENT IS CAPTURED UNDER (MDR #: 2031527-2019-00472). NOW, APPROXIMATELY ONE (1) YEAR POST REINTERVENTION DURING ROUTINE FOLLOW UP THE PATIENT PRESENTS WITH POSSIBLE 1A ENDOLEAK AND OCCLUDED RIGHT COMMON ILIAC LIMB POSSIBLY DUE TO OUTFLOW. THE PATIENT WAS REPORT AS DOING WELL. ADDITIONAL INFORMATION: AN INTERVENTION WAS COMPLETED. THE PHYSICIAN PERFORMED AN ENDARTERECTOMY AND IMPLANTED THREE (3) OVATION ILIAC STENT GRAFTS TO RESOLVE THE REPORTED EVENT. THE PATIENT WAS REPORT AS DOING GOOD.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 10830341 ↗
• InjuryAug 6, 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. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH ANEURYSM SAC GROWTH (UNKNOWN DIAMETER) AND NO VISIBLE ENDOLEAK PER CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) SCAN. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO RE-INTERVENE. THE PATIENT WILL CONTINUE TO BE MONITORED AND IS REPORTEDLY IN STABLE CONDITION.

  Patient problems: Aneurysm

  MAUDE report 10371530 ↗
• InjuryJul 22, 2020Use of Device Problem; Device-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Device-Device Incompatibility; 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 (1) MONTH POST INITIAL PROCEDURE, A ROUTINE FOLLOW UP CT (COMPUTED TOMOGRAPHY) IDENTIFIED A TYPE 1A ENDOLEAK. THE PATIENT IS CURRENTLY STABLE AND IS BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10306264 ↗
• InjuryDec 23, 2019Insufficient 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 AND HALF (2.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH AN ENDOLEAK OF INDETERMINATE ORIGIN (SUSPECTED TYPE 2). THE PATIENT IS CURRENTLY BEING MONITORED. NOTE: THIS PATIENT HAD A PREVIOUS REPORT OF A TYPE 2 ENDOLEAK (NON DEVICE RELATED FAILURE) IN (B)(6) OF 2018.

  Patient problems: Failure of Implant

  MAUDE report 9513449 ↗
• InjuryDec 22, 2019Insufficient 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. APPROXIMATELY TEN (10) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IA ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE BUT SURGERY HAS NOT BEEN SCHEDULED. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9508920 ↗
• InjuryDec 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) MONTH POST-OP, A COMPUTED TOMOGRAPHY (CT) WAS COMPLETED REVEALING THE PRESENCE OF A TYPE IA ENDOLEAK. THE PATIENT CONDITION WAS REPORTED AS GOOD AND THE PATIENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED REPORTING THAT RE-INTERVENTION WAS PERFORMED WITH SUCCESSFUL COILING OF THE TYPE IA ENDOLEAK. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONALLY, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST TYPE II ENDOLEAK (NON-DEVICE RELATED) OF THE LUMBAR ARTERIES OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 9452890 ↗
• InjuryDec 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 CASE CONTINUED WITHOUT ADDITIONAL INCIDENT. 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 9404697 ↗
• InjuryOct 18, 2019Fluid/Blood Leak; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem; Fluid/Blood Leak; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem

  THE PATIENT WAS TREATED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM. 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 DID NOT APPEAR FILLED A DECISION WAS MADE TO IMPLANT A PALMAZ STENT GRAFT AT THE LEVEL OF THE SEALING RINGS SUCCESSFULLY ACHIEVING PROXIMAL SEAL. DIFFICULTY WAS EXPERIENCE WHILE ATTEMPTING TO CANNULATE THE CONTRALATERAL LIMB, THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE. ONE DAY POST-OP THE PATIENT UNDERWENT EMERGENT FEM-FEM CROSSOVER BYPASS HOWEVER, SUBSEQUENTLY EXPIRED. THE PHYSICIAN REPORTED THE PATIENT HAD REFUSED BLOOD PRODUCTS. THE CAUSE OF DEATH WAS NOT INITIALLY REPORTED.

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

  MAUDE report 9210141 ↗
• InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  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 WITH NO EVIDENCE OF AN ENDOLEAK OF ANY TYPE. AT THE CONCLUSION OF THE PROCEDURE THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 9121110 ↗
• InjurySep 13, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AT THE FINAL SCAN AN ENDOLEAK WAS DETECTED AT THE LOCATION OF THE LEFT ILIAC LIMB AND THE AORTIC MAIN BODY; SUSPECTED TYPE IIIA ENDOLEAK. A DECISION WAS MADE TO BALLOON BOTH LIMBS WHICH IMPROVED THE ENDOLEAK HOWEVER, DID NOT SUCCESSFULLY RESOLVE IT. THE PHYSICIAN ELECTED TO IMPLANT AN ATRIUM STENT IN THE AORTIC BODY OVER THE JUNCTION OF THE LEFT ILIAC LIMB HOWEVER, THE ENDOLEAK REMAINED. AN ADDITIONAL IMPLANT WAS PLACED; VISIPRO, INTO THE RIGHT AND AN ENDOLEAK WAS STILL DETECTED. THE PHYSICIAN CONCLUDED THE CASE WITH AN ENDOLEAK PRESENT. THE PATIENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THERE WAS A POSSIBLE TYPE II ENDOLEAK (NON-DEVICE RELATED) FROM THE INTERNAL MESENTERIC ARTERY AS WELL AS A POSSIBLE DUAL LIMB PLACEMENT NOTED FROM THE NON-DIAGNOSTIC ANGIOGRAM MOVIES AVAILABLE. ADDITIONALLY, THE LEFT ILIAC ARTERY MEASUREMENT OF 5.3MM WAS OFF LABEL (PER THE IFU IT SHOULD BE 8-25MM).

  Patient problems: Aneurysm

  MAUDE report 9036968 ↗

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