Ovation iX Abdominal Stent Graft System Aortic Body (REF TV-AB2380-J)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI M701TVAB2380J1), received between Nov 20, 2015 and Dec 9, 2025 — classified as 3 deaths, 51 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (14 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH AN ANEURYSM THAT IS STILL GROWING. THE PATIENT IS ASYMPTOMATIC BUT AAA IS NOW OVER 5CM. THE PATIENT IS BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED. ADDITIONALLY, AN INTERNAL CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE 1A ENDOLEAK OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE 1A ENDOLEAK WAS DISCOVERED DURING REVIEW OF THE COMPUTED TOMOGRAPHY (CT) SCAN DATED ON (B)(6) 2025.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 23758470 ↗
• InjuryJan 20, 2025Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH A PALMAZ (NON-ENDOLOGIX) STENT AND ALSO EMBOLIZED THE 1A ENDOLEAK WITH COOK (NON-ENDOLOGIX) COILS ON (B)(6) 2025. THE PATIENT IS REPORTED AS RECOVERING WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 21193157 ↗
• InjuryNov 15, 2022Complete Blockage; Appropriate Device Problem Term/Code Not Available; Complete Blockage; 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 AND A HALF (3.5) YEARS POST-INITIAL PROCEDURE, THE PATIENT WAS BROUGHT IN EMERGENTLY DUE TO AN OCCLUSION WITHIN THE DEVICE. RE-INTERVENTION WAS COMPLETED, AND THE PATIENT RECEIVED AN ¿EXTRA-ANATOMIC GRAFT¿. THE FINAL PATIENT STATUS WAS REPORTED AS BEING STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15801287 ↗
• InjuryApr 20, 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. APPROXIMATELY THREE AND A HALF (3.5) YEARS POST INITIAL PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED OCCLUSION OF THE PROXIMAL AORTA BELOW THE SEALING RINGS. REINTERVENTION IS SCHEDULED. THE PATIENT IS DOING WELL.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 14160996 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT WITH NO VISIBLE ENDOLEAK DURING A ROUTINE FOLLOW UP. THE PATIENT STATUS WAS REPORTED AS BEING STABLE. THE PHYSICIAN WILL BE REFERRING PATIENT TO A RADIOLOGIST.

  Patient problems: Failure of Implant

  MAUDE report 13909575 ↗
• InjuryMay 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED AN INDETERMINATE ENDOLEAK. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 11860210 ↗
• InjurySep 3, 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 1YEAR POST INITIAL PROCEDURE DURING A ROUTINE CT (COMPUTED TOMOGRAPHY) A TYPE 1A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IS PLANNING RE-INTERVENTION ON (B)(6) 2020. PATIENT IS STABLE. ADDITIONAL INFORMATION: A RE-INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO (2) PROXIMAL EXTENSIONS. THE TYPE 1A ENDOLEAK WAS RESOLVED AND THE FINAL PATIENT STATUS WAS REPORTED AS BEING GOOD.

  Patient problems: Failure of Implant

  MAUDE report 10487975 ↗
• DeathAug 31, 2020Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN RIGHT COMMON ILIAC ARTERY (RCIA) ANEURYSM. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE ABSENTS OF ABDOMINAL AORTIC ANEURYSM (AAA). 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 AND ANAPHYLACTIC SHOCK EVIDENCED BY A DROP IN BLOOD PRESSURE AND WAS TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. IT WAS REPORTED THAT THE PATIENT IS ALLERGIC TO MANY THINGS SUCH AS POWDER, LATEX, BANANA AND KIWI. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF AN INTRAOPERATIVE 1A ENDOLEAK AND THE PHYSICIAN ELECTED TO CONCLUDED THE PROCEDURE AS THE PATIENTS VITAL SIGNS WERE UNSTABLE. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY FOUR (4) HOURS AFTER THIS PROCEDURE CONCLUDED. THE CAUSE OF DEATH HAS NOT BEEN REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 10472225 ↗
• DeathJul 1, 2020Complete Blockage; Patient-Device Incompatibility; Complete Blockage; Patient-Device Incompatibility

  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 PROCEDURE, PATIENT WAS PRESENT IN THE HOSPITAL IN DEEP DISTRESS. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED THAT BOTH OVATION IX AORTIC MAIN BODIES AND LIMBS WERE COMPLETELY OCCLUDED. IT WAS REPORTED THAT THIS PATIENT IS EXTREMELY OBESE AND TESTED POSITIVE FOR METHAMPHETAMINE USE. THE PHYSICIAN INDICATED THAT THE METHAMPHETAMINE USE PLAYED A ROLE IN THE GRAFTS BEING COMPLETELY CLOTTING OFF. THE PHYSICIAN STATED THAT THE PATIENT STILL HAD BLOOD FLOW TO LEGS FROM RETROGRADE FLOW FROM HYPOGASTRIC ARTERIES. IT WAS REPORTED THAT THE PATIENT EXPIRED THREE (3) DAYS LATER ((B)(6) 2020) DUE TO COMPLICATION WAS RHABDOMYOLYSIS.

  Patient problems: Death; Occlusion

  MAUDE report 10222333 ↗
• InjuryApr 20, 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 WITH AN INTRAOPERATIVE TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO WAIT UNTIL THE PATIENTS 30 DAY FOLLOW UP TO ADDRESS THE TYPE 1A ENDOLEAK. THE PATIENT WAS REPORTED AS STABLE AND IS BEING MONITORED.

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

  MAUDE report 9979975 ↗
• InjuryDec 5, 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. 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 9418913 ↗
• InjurySep 19, 2019Fluid/Blood Leak; Deformation Due to Compressive Stress; Material Integrity Problem; Fluid/Blood Leak; Deformation Due to Compressive Stress; 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 PARTIALLY FILLED WITH A TYPE IA ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO IMPLANT A PALMAZ (NON-ENDOLOGIX) STENT AT THE LEVEL OF THE SEALING RINGS SUCCESSFULLY RESOLVING THE ENDOLEAK. ADDITIONALLY, THE LEFT LIMB APPEARED PARTIALLY COLLAPSED. THE PHYSICIAN USED TWO (2) EVERCROSS PTA BALLOONS SUCCESSFULLY EXPANDING THE LIMB. 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 9091819 ↗
• InjurySep 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TWO (2) YEARS POST-OP A TYPE IA ENDOLEAK WAS DETECTED DURING FOLLOW-UP. THE PATIENT IS REPORTED IN STABLE CONDITION. THE PHYSICIAN PLANS TO TREAT THE PATIENT AT A LATER DATE. THE PATIENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A SECONDARY ENDOVASCULAR PROCEDURE FOR LEFT ILIAC WITH NON ENDOLOGIX STENT PLACEMENT AND COILING OF A LUMBAR ARTERY (TYPE II ENDOLEAK (NON-DEVICE RELATED) OCCURRED ON (B)(6) 2017 THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 9091611 ↗
• InjuryJul 5, 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. A DECISION WAS MADE TO IMPLANT A PALMAZ STENT AT THE LEVEL OF THE SEALING RINGS. THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE II ENDOLEAK (LUMBAR ¿ NON-DEVICE RELATED) AND AN INTRAOPERATIVE RIGHT RENAL SNORKEL PLACEMENT (DUE TO MARKERS BEING PLACED AT RENAL ARTERY INSTEAD OF BELOW) HAD OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED.

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

  MAUDE report 8765575 ↗
• InjuryJun 13, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH THE OVATION IX ABDOMINAL STENT GRAFT SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). POST POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE PATIENT EXPERIENCED HYPOTENSION DUE TO A SUSPECTED POLYMER LEAK AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. A PALMAZ (NON- ENDOLOGIX) STENT WAS REQUIRED BUT NO ENDOLEAK WAS IDENTIFIED. 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 8697929 ↗
• InjuryJun 5, 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. AN INTRAOPERATIVE TYPE IA ENDOLEAK WAS IDENTIFIED. A DECISION WAS MADE TO BALLOON AND IMPLANT A PALMAZ STENT AT THE LEVEL OF THE SEALING RINGS. THE FINAL ANGIOGRAM CONFIRMED THERE WAS NO VISIBLE ENDOLEAK OF ANY TYPE PRESENT AND THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED.

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

  MAUDE report 8672635 ↗
• InjuryApr 18, 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. A PALMAZ (NON- ENDOLOGIX) STENT WAS PLACED AT THE LEVEL OF THE SEALING RINGS. THE FINAL ANGIOGRAM CONFIRMED THE ANEURYSM WAS EXCLUDED WITH NO OBSERVATION OF AN ENDOLEAK OF ANY TYPE PRESENT. THE PROCEDURE CONCLUDED WITHOUT FURTHER INCIDENT. THE PATIENT WILL CONTINUE TO BE MONITORED.

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

  MAUDE report 8529578 ↗
• InjuryApr 5, 2019Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, THE CASE WAS OFF LABEL AS THE JUXTARENAL ANGLE WAS GREATER THAN THE IFU GUIDELINES. THE MAIN BODY LANDED LOWER THAN THE INTENDED SEAL ZONE CAUSING A TYPE IA ENDOLEAK. A NON-ENDOLOGIX (PALMAZ) STENT WAS DEPLOYED TO SEAL THE TYPE IA ENDOLEAK; HOWEVER, IT DID NOT COMPLETELY RESOLVE THE ENDOLEAK. THE PHYSICIAN DECIDED TO LEAVE AS IS AND IF THE TYPE IA ENDOLEAK DOES NOT RESOLVE IN 30 DAYS THE NEED FOR RE-INTERVENTION WILL BE DETERMINED. THE PATIENT IS BEING MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 8488222 ↗
• InjuryFeb 26, 2019Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM AND TWO ADDITIONAL OVATION IX ILIAC LIMB EXTENSIONS WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY NINETEEN DAYS POST OP, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN IN BACK, LEGS AND ABDOMEN. CT REVEALED AN OCCLUDED OVATION GRAFT FROM THE RINGS DOWN AND FILLED WITH THROMBUS AS WELL AS A KINK IN THE GRAFT BELOW THE RINGS. THE PATIENT WAS ALSO DIAGNOSED WITH AN AORTIC DISSECTION LOCATED ABOVE THE MAIN BODY CROWN, THIS IS ALSO THE LOCATION OF AN AORTIC INTRAMURAL HEMATOMA. PATIENT WAS SENT TO THE OPERATING ROOM FOR RE-INTERVENTION. BI-LATERAL CUTDOWNS WERE PERFORMED, A THROMBECTOMY OF THE GRAFT WAS DONE TO REMOVE THE THROMBUS. THREE NON-ENDOLOGIX BARE METAL STENTS WERE IMPLANTED TO REPAIR THE KINK IN THE GRAFT. FLOW WAS RESTORED AND KINK RESOLVED. PATIENT CONDITION WAS REPORTED AS STABLE POST RE-INTERVENTION. PATIENT WILL RETURN AT A LATER DATE TO REPAIR THE DISSECTION.

  Patient problems: Aortic Dissection; Occlusion; Pain; Thrombus

  MAUDE report 8372232 ↗
• DeathJan 29, 2019Use of Device Problem; Obstruction of Flow; Use of Device Problem; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM STENT; INTRAOPERATIVE OCCLUSION AND RUPTURED RIGHT EXTERNAL ILIAC WAS NOTED AND RESOLVED AFTER A GORE VIABHAN (NON-ENDOLOGIX) DEVICE AND OVATION 12X80 LIMB WERE IMPLANTED ACROSS THE RUPTURED AREA, WHICH SHOWED GOOD FLOW ON FINAL ANGIOGRAM. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. THE FOLLOWING MORNING, PATIENT COMPLAINED OF LEG AND BACK PAIN AND CT SHOWED RE-OCCLUSION OF THE GRAFT. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM (OR) AND A SHEATH WAS ADVANCED TO THE BIFURCATION GRAFT; THE PHYSICIAN ELECTED TO LEAVE AN INFUSION CATHETER AND DRIP TPA FOR 24 HOURS. THE PATIENT DECOMPENSATED LATE IN THE EVENING AND PASSED AWAY.

  Patient problems: Death; Occlusion; Pain; Rupture

  MAUDE report 8284655 ↗
• InjuryJan 11, 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. UPON POLYMER FILL OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE WAS OBSERVED TO HAVE EMPTIED. THE PATIENT EXPERIENCED HYPOTENSION EVIDENCED BY A DROP IN BLOOD PRESSURE, AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION: ADDITIONALLY, A TYPE 2 ENDOLEAK (NON -DEVICE RELATED FAILURE) FROM THE LUMBAR ARTERY WAS IDENTIFIED. THE INTRAOPERATIVE TYPE IA ENDOLEAK HAS BEEN RESOLVED ON ITS OWN PER THE ONE (1) MONTH POST COMPUTED TOMOGRAPHY (CT) SCAN.

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

  MAUDE report 8242596 ↗
• InjuryDec 19, 2018Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY TREATED WITH THE OVATION IX ABDOMINAL AORTIC ANEURYSM SEALING SYSTEM . THIRTEEN (13) DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH NUMBNESS IN THE RIGHT LEG (LIMB OCCLUSION). THE PHYSICIAN ELECTED TO TREAT THE PATIENT THE FOLLOWING DAY BY IMPLANTING TWO (2) STENT BALLOON (NON-ENDOLOGIX) DEVICES. THE PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 8182681 ↗
• InjuryDec 5, 2018Leak/Splash; Off-Label Use; Device Dislodged or Dislocated; Leak/Splash; Off-Label Use; Device Dislodged or Dislocated

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT WAS OUTSIDE THE INDICATIONS FOR USE DUE TO A SHORT NECK; HOWEVER, THE PHYSICIAN ELECTED TO TREAT THE PATIENT THE PATIENT BY PLACING THE STENT GRAFT HIGHER THAN RECOMMENDED. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK THAT COULD NOT BE RESOLVED FOLLOWING BALLOONING. UPON AN ATTEMPT TO PLACE A NON-ELGX BALLOON EXPANDABLE STENT, THE AORTIC BODY STENT GRAFT WAS DISPLACED DISTAL ~4MM UPON DEPLOYMENT OF THE STENT, AND THE TYPE IA ENDOLEAK REMAINED. BILATERAL RENAL STENTS WERE PLACED (RENAL SNORKEL), FOLLOWED BY THE PLACEMENT OF AN AORTIC CUFF (GORE) WHICH DID NOT RESOLVE THE LEAK. THE ENDOLEAK WAS CONFIRMED THE FOLLOWING DAY VIA ULTRASOUND EVIDENCED BY CONTRAST ENTERING THE SAC. A SECONDARY INTERVENTION IS PLANNED AT A LATER DATE TO SNORKEL THE SMA AND PLACE AN ADDITIONAL CUFF TO RESOLVE THE LEAK. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 8136073 ↗
• InjuryNov 17, 2018Leak/Splash; Improper or Incorrect Procedure or Method; Malposition of Device; Leak/Splash; Improper or Incorrect Procedure or Method; Malposition of Device

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS INITIALLY IMPLANTED. DURING CONTRA-LATERAL GATE CANNULATION, THE PHYSICIAN BELIEVED THAT THE CONTRALATERAL GATE WAS CANNULATED; HOWEVER, UPON DEPLOYMENT OF THE CONTRALATERAL LIMB, IT WAS CONFIRMED THAT THE IPSILATERAL LEG OF THE AORTIC BODY GRAFT HAD BEEN CANNULATED. THEREFORE, THE TWO LIMBS EXTENSIONS WERE DEPLOYED IN THE IPSI-LATERAL SIDE. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. THE PATIENT WAS REPORTED TO HAVE BLOOD FLOW DOWN BOTH LEGS AT THE COMPLETION OF THE CASE. FLOW INTO THE SACK WAS MINIMAL. THE PATIENT WAS STABLE. THE PHYSICIAN DECIDED TO SCHEDULE TREATMENT FOR MONDAY (B)(6) 2018, TO FULLY EXCLUDE THE ANEURYSM, AS THE HOSPITAL DID NOT HAVE PLUGS OR COILS TO OCCLUDE THE CONTRA GATE, AND MONITOR THE PATIENT CLOSELY OVER THE WEEKEND. UNFORTUNATELY, THE PATIENT PRESENTED WITH A COLD LEG ON EITHER (B)(6) 2018. ON (B)(6) 2018, FEM/FEM WAS PERFORMED URGENTLY. THE PHYSICIAN USED A BARE METAL STENT (BMS) TO PROP OPEN THE IPSI LIMB AND CRUSH THE LIMB FEEDING THE PATIENTS LEFT COMMON ILIAC. FLOW WAS RESTORED TO THE LOWER EXTREMITY. THE PHYSICIAN WAS LIMITED TO AN ARM STICK GIVEN THE FRESH OPEN GROINS. ATTEMPTS TO

  Patient problems: Failure of Implant

  MAUDE report 8082215 ↗
• InjuryOct 31, 2018Leak/Splash; Insufficient Device Problem Information; Leak/Splash; Insufficient Device Problem Information

  AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, THE PATIENT PRESENTED WITH CLAUDICATION. ON (B)(6) 2018, THROMBUS IN THE LIMBS OF THE OVATION GRAFT WAS TREATED WITH LITIC THERAPY TO LYSE THE THROMBUS. ADDITIONALLY, TWO ILIAC LIMB EXTENSIONS WERE PLACED ABOVE THE PREVIOUSLY PLACED LIMBS TO A LEVEL OF APPROXIMATELY 15MM BELOW THE SECONDARY RING. THE FOLLOWING DAY THE PATIENT WAS REPORTED TO BE DOING FINE. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 8025051 ↗

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