TREO Abdominal Stent-Graft SystemRecalls & reported problems across all models

We found 73 models of TREO Abdominal Stent-Graft System by Bolton Medical Inc. in the FDA's device registry (GUDID). Together they are named in 129 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2023 and Jul 27, 2026 — classified as 7 deaths, 103 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (82 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

TREO Abdominal Stent-Graft System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 3, 2023Open, Classified

   Potential for the incorrect size stent-graft than the printed carton label.

   Z-1689-2023 · Root cause: Process control · names 24 of these models · Recall details · FDA record ↗

Most reported TREO Abdominal Stent-Graft System problems

TREO Abdominal Stent-Graft System models

73 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TREO Abdominal Stent-Graft System 28-L2-13-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall4 reports
• TREO Abdominal Stent-Graft System 28-L2-13-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• TREO Abdominal Stent-Graft System 28-L2-15-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• TREO Abdominal Stent-Graft System 28-L2-15-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• TREO Abdominal Stent-Graft System 28-B2-30-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• TREO Abdominal Stent-Graft System 28-B2-28-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• TREO Abdominal Stent-Graft System 28-L2-15-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-L2-17-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-L2-20-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-L2-17-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-B2-26-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-B2-28-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-B2-30-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-C2-26-040U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• TREO Abdominal Stent-Graft System 28-S2-13-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-L2-24-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-B2-24-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-B2-36-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-28-040U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-30-040U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-22-055U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-24-055U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-26-055U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-C2-28-070U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• TREO Abdominal Stent-Graft System 28-L2-13-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  6 reports
• TREO Abdominal Stent-Graft System 28-B2-24-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• TREO Abdominal Stent-Graft System 28-B2-33-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• TREO Abdominal Stent-Graft System 28-L2-20-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death5 reports
• TREO Abdominal Stent-Graft System 28-B2-26-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  5 reports
• TREO Abdominal Stent-Graft System 28-B2-28-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death4 reports
• TREO Abdominal Stent-Graft System 28-L2-20-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-15-160U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-B2-26-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-13-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-09-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-13-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-20-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-24-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 deaths3 reports
• TREO Abdominal Stent-Graft System 28-B2-24-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death3 reports
• TREO Abdominal Stent-Graft System 28-B2-26-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 reports
• TREO Abdominal Stent-Graft System 28-L2-24-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-13-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-B2-36-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-B2-33-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-B2-26-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-20-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-24-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death2 reports
• TREO Abdominal Stent-Graft System 28-L2-11-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-15-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-17-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-09-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-15-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-B2-28-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-B2-30-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 reports
• TREO Abdominal Stent-Graft System 28-L2-20-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-11-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-09-160U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-24-160U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-22-100U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-28-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-30-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-C2-30-055U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-C2-33-055U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-17-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 death1 report
• TREO Abdominal Stent-Graft System 28-L2-11-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-17-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-11-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-13-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-17-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-L2-20-140U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-30-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-33-080U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report
• TREO Abdominal Stent-Graft System 28-B2-28-120U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 report

Recent TREO Abdominal Stent-Graft System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Fracture

  "The Core Lab sent notification on (b)(6) 2026 having identified a barb break at the proximal aspect of the uncovered stent for subject (b)(6) 4-year imaging dated (b)(6) 2026. Additional information received on 07/02/2026:The subject's 4-year follow-up occurred same day and remains asymptomatic from an aneurysmal perspective without Endo leaks and stable size of residual aneurysm sac. There were no AEs that occurred as a result of this barb break identified by the Core Lab.The PI reviewed the imaging and did not identify any stent graft integrity issues, therefore no device deficiency reported by the site. The x-ray report also states 'no gross evidence of migration or stent fracture'."Patient Outciome: "Pending details from the site regarding status of subject or if any AEs have occurred as a result of."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017622 ↗
• MalfunctionJun 23, 2026Difficult or Delayed Separation

  "DURING THE CLASP RELEASE STAGE OF THE PROCEDURE THE DISTAL CLASP MOVED PROXIMALLY RATHER THAN THE PROXIMAL CLASP RETRACTING DISTALLY TO RELEASE THE SUPRARENAL FIXATION. SOME DIFFICULTY WAS OBSERVED REMOVING THE DELIVERY SYSTEM FROM THE PATIENT. WE FEEL THAT IT WAS DUE TO THE PRESSURE OF THE AORTA PUSHING DOWN ON THE DELIVERY SYSTEM AND STENT GRAFT. THE PATIENT ANATOMY APPEARED TORTUOUS WITH BENDING POSTERIORLY. GOOD PATIENT OUTCOME." PATIENT OUTCOME; "NO PATIENT INJURY OR ADVERSE OUTCOMES ASSOCIATED WITH THIS CASE. FOLLOW-UP WITH PHYSICIAN MONDAY 06/01/2026 WAS POSITIVE AND PATIENT WAS SENT HOME ON TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25600210 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  "ON (B)(6) 2026, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING REGARDING >5MM GROWTH OF SUBJECT'S AORTA AT PROXIMAL ASPECT OF THE STENT FOR THEIR 3-YEAR CT DATED (B)(6) 2025 IN COMPARISON TO THE 30-DAY TIMEPOINT. THE INVESTIGATOR REVIEWED THE FINDING AND SUBJECT'S IMAGING AND DID NOT AGREE WITH THE CORE LAB'S ASSESSMENT, SPECIFYING THE FOLLOWING: "SUBJECT HAS NO CHANGE IN THE AORTIC NECK FROM IMPLANTATION. MEASUREMENT OF THE NECK ON THE AXIAL IMAGE ATTACHED OVERCALLS THE DIAMETER THAT IS INDEED ANEURYSMAL AT THE TOP OF THE UNCOVERED STRUTS OF THE TREO GRAFT. THERE IS ANGULATION THAT IS MAKING THAT DIAMETER LARGER THAN IT REALLY IS AND IS BEST SEEN IN THE SAGITTAL VIEW FOR MEASUREMENT. ON DIRECT COMPARISON OF THE INITIAL AND MOST RECENT CT, THERE IS NO CHANGE IN THE NECK AT THE TOP OF THE UNCOVERED STRUTS OR AT THE SHORT RING LIKE SEAL ZONE OF THE NECK SINCE IMPLANTATION. NO FURTHER ACTION IS REQUIRED." THE CSM INQUIRED AFTERWARDS WITH THE CORE LAB REGARDING THE SITE'S ASSESSMENT, AND CORE LAB SPECIFIED THAT PER THEIR CORE LAB PI "PROXIMAL AORTIC GROWTH IS PRESENT IN THE PROXIMAL ASPECT OF THE STENT BUT STILL APPEARS TO HAVE SEAL WITH MINIMAL GRAFT MOVEMENT". THE CORE LAB

  Patient problems: Aneurysm expansion

  MAUDE report 25416074 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  "ON 11MAY2026, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING REGARDING >5MM GROWTH OF SUBJECT'S AORTA AT PROXIMAL ASPECT OF THE STENT FOR THEIR 3-YEAR CT DATED (B)(6) 2025 IN COMPARISON TO THE 30-DAY TIMEPOINT. THE INVESTIGATOR REVIEWED THE FINDING AND SUBJECT'S IMAGING AND DID NOT AGREE WITH THE CORE LAB'S ASSESSMENT, SPECIFYING THE FOLLOWING: "SUBJECT HAS NO CHANGE IN THE AORTIC NECK FROM IMPLANTATION. MEASUREMENT OF THE NECK ON THE AXIAL IMAGE ATTACHED OVERCALLS THE DIAMETER THAT IS INDEED ANEURYSMAL AT THE TOP OF THE UNCOVERED STRUTS OF THE TREO GRAFT. THERE IS ANGULATION THAT IS MAKING THAT DIAMETER LARGER THAN IT REALLY IS AND IS BEST SEEN IN THE SAGITTAL VIEW FOR MEASUREMENT. ON DIRECT COMPARISON OF THE INITIAL AND MOST RECENT CT, THERE IS NO CHANGE IN THE NECK AT THE TOP OF THE UNCOVERED STRUTS OR AT THE SHORT RING LIKE SEAL ZONE OF THE NECK SINCE IMPLANTATION. NO FURTHER ACTION IS REQUIRED." THE CSM INQUIRED AFTERWARDS WITH THE CORE LAB REGARDING THE SITE'S ASSESSMENT, AND CORE LAB SPECIFIED THAT PER THEIR CORE LAB PI "PROXIMAL AORTIC GROWTH IS PRESENT IN THE PROXIMAL ASPECT OF THE STENT BUT STILL APPEARS TO HAVE SEAL WITH MINIMAL GRAFT MOVEMENT". THE CORE LAB AL

  Patient problems: Aneurysm expansion

  MAUDE report 25416062 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  "ON (B)(6) 2026, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING REGARDING >5MM GROWTH OF SUBJECT'S AORTA AT PROXIMAL ASPECT OF THE STENT FOR THEIR 3-YEAR CT DATED (B)(6) 2025 IN COMPARISON TO THE 30-DAY TIMEPOINT. THE INVESTIGATOR REVIEWED THE FINDING AND SUBJECT'S IMAGING AND DID NOT AGREE WITH THE CORE LAB'S ASSESSMENT, SPECIFYING THE FOLLOWING: "SUBJECT HAS NO CHANGE IN THE AORTIC NECK FROM IMPLANTATION. MEASUREMENT OF THE NECK ON THE AXIAL IMAGE ATTACHED OVERCALLS THE DIAMETER THAT IS INDEED ANEURYSMAL AT THE TOP OF THE UNCOVERED STRUTS OF THE TREO GRAFT. THERE IS ANGULATION THAT IS MAKING THAT DIAMETER LARGER THAN IT REALLY IS AND IS BEST SEEN IN THE SAGITTAL VIEW FOR MEASUREMENT. ON DIRECT COMPARISON OF THE INITIAL AND MOST RECENT CT, THERE IS NO CHANGE IN THE NECK AT THE TOP OF THE UNCOVERED STRUTS OR AT THE SHORT RING LIKE SEAL ZONE OF THE NECK SINCE IMPLANTATION. NO FURTHER ACTION IS REQUIRED." THE CSM INQUIRED AFTERWARDS WITH THE CORE LAB REGARDING THE SITE'S ASSESSMENT, AND CORE LAB SPECIFIED THAT PER THEIR CORE LAB PI "PROXIMAL AORTIC GROWTH IS PRESENT IN THE PROXIMAL ASPECT OF THE STENT BUT STILL APPEARS TO HAVE SEAL WITH MINIMAL GRAFT MOVEMENT". THE CORE LAB

  Patient problems: Aneurysm expansion

  MAUDE report 25415819 ↗
• InjuryJun 2, 2026Device Endoleak

  "ADDITIONAL ADDENDUM FOR (B)(6) ON LATEST FORM. SUBJECT (B)(6) 4-YEAR FOLLOW-UP OCCURRED ON (B)(6) 2026 WITH THE CT DATED ON (B)(6) 2026 REFLECTING A CONTINUED INCREASE IN ANEURYSM DUE TO A TYPE IIB ENDOLEAK. THE INVESTIGATOR ASSESSED THE MAX DIAMETER OF THE ANEURYSM AT 81MM, WHICH IS A 23MM INCREASE COMPARED TO 30-DAY (58MM) ASSESSMENT AND AN 11MM INCREASE COMPARED TO THE PREVIOUS 3-YEAR (70MM), MAKING FOR A 2ND OCCURRENCE OF >5MM ENLARGEMENT. THE SUBJECT REPORTED NO SYMPTOMS DURING THEIR FOLLOW-UP. THE SUBJECT'S LAST REINTERVENTION WAS ON (B)(6) 2025, WHICH WAS BEFORE THEIR 3-YEAR IN 2025 WHEN THE FIRST OCCURRENCE >5MM ENLARGEMENT WAS NOTED." PATIENT OUTCOME: "NO ACTION TAKEN YET AS OF ON (B)(6) 2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367324 ↗
• InjuryJun 2, 2026Device Endoleak

  "ADDITIONAL ADDENDUM FOR AAA-0732 ON LATEST FORM. SUBJECT TPA-004-004'S 4-YEAR FOLLOW-UP OCCURRED ON(B)(6) 2026 WITH THE CT DATED (B)(6) 2026 REFLECTING A CONTINUED INCREASE IN ANEURYSM DUE TO A TYPE IIB ENDOLEAK. THE INVESTIGATOR ASSESSED THE MAX DIAMETER OF THE ANEURYSM AT 81MM, WHICH IS A 23MM INCREASE COMPARED TO 30-DAY (58MM) ASSESSMENT AND AN 11MM INCREASE COMPARED TO THE PREVIOUS 3-YEAR (70MM), MAKING FOR A 2ND OCCURRENCE OF >5MM ENLARGEMENT. THE SUBJECT REPORTED NO SYMPTOMS DURING THEIR FOLLOW-UP. THE SUBJECT'S LAST REINTERVENTION WAS IN FEB 2025, WHICH WAS BEFORE THEIR 3-YEAR IN 2025 WHEN THE FIRST OCCURRENCE >5MM ENLARGEMENT WAS NOTED." PATIENT OUTCOME: "NO ACTION TAKEN YET AS OF 12MAY2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367322 ↗
• InjuryJun 2, 2026Device Endoleak

  "ADDITIONAL ADDENDUM FOR AAA-0732 ON LATEST FORM. SUBJECT (B)(6) 4-YEAR FOLLOW-UP OCCURRED ON (B)(6) 2026 WITH THE CT DATED (B)(6) 2026 REFLECTING A CONTINUED INCREASE IN ANEURYSM DUE TO A TYPE IIB ENDOLEAK. THE INVESTIGATOR ASSESSED THE MAX DIAMETER OF THE ANEURYSM AT 81MM, WHICH IS A 23MM INCREASE COMPARED TO 30-DAY (58MM) ASSESSMENT AND AN 11MM INCREASE COMPARED TO THE PREVIOUS 3-YEAR (70MM), MAKING FOR A 2ND OCCURRENCE OF >5MM ENLARGEMENT. THE SUBJECT REPORTED NO SYMPTOMS DURING THEIR FOLLOW-UP. THE SUBJECT'S LAST REINTERVENTION WAS IN (B)(6) 2025, WHICH WAS BEFORE THEIR 3-YEAR IN 2025 WHEN THE FIRST OCCURRENCE >5MM ENLARGEMENT WAS NOTED." PATIENT OUTCOME: "NO ACTION TAKEN YET AS OF (B)(6) 2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367321 ↗
• InjuryMay 1, 2026Device Endoleak

  "POSSIBLE TYPE 3 FABRIC TEAR AT LEAVEL OF LIMB LOCK POST IMPLANT OF CONTRALATERAL LIMB, LIMB ADDED TO FIX ENDOLEAK" PATIENT PUTCOME: "PATIENT DOING WELL."

  Patient problems: Clinical Endoleak

  MAUDE report 25056952 ↗
• InjuryApr 23, 2026Device Endoleak

  I WAS MADE AWARE LAST NIGHT OF AN EXPLANT OF A TREO DEVICE, PHYSICIAN STATED THERE WAS TYPE 3 ENDOLEAK AND THE DECISION WAS MADE TO EXPLANT THE DEVICE. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: AT THE TIME OF IMPLANT BILATERAL RENAL ACCESSORIES WERE EMBOLIZED. POST IMPLANT ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF ANEURYSM WITHOUT EVIDENCE OF ENDOLEAK. A CT PERFORMED ON (B)(6) 2021 SHOWED A POSSIBLE TYPE 2 ENDOLEAK "LIKELY DUE TO A NON-EMBOLIZED ACCESSORY LEFT RENAL", SAC WAS STABLE. HE HAD MULTIPLE INTERVENTIONS FOR A TYPE 2 ENDOLEAK WHICH LED TO A LAPAROSCOPIC LIGATION OF IMA AND MULTIPLE LUMBARS ON (B)(6) 2024. HE HAD A CV MRA ON (B)(6) 2025 THAT SHOWED SAC 7.2 CM, THE REPORT ALSO STATED "RIGHT COMMON ILIAC- DISTAL SEGMENT IS ECTATIC, THE ILIAC LIMB OF AORTOILIAC STENT GRAFT EXTENDS INTO THE COMMON ILIAC ARTERY. INCOMPLETE APPOSITION OF THE DISTAL END OF THE STENT GRAFT." EXPLANT PERFORMED 03/28/2026. ON THE OP REPORT IT STATES 'SIGNIFICANT BLEEDING WAS NOTED FROM A DEFECT IN THE GRAFT FROM THE POSTERIOR MAIN BODY. PATIENT OUTCOME: "NO INFO PROVIDED ON PATIENT. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: Clinical Endoleak

  MAUDE report 24967241 ↗
• InjuryApr 23, 2026Device Endoleak

  "I WAS MADE AWARE LAST NIGHT OF AN EXPLANT OF A TREO DEVICE, PHYSICIAN STATED THERE WAS TYPE 3 ENDOLEAK AND THE DECISION WAS MADE TO EXPLANT THE DEVICE. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 04/03/2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: AT THE TIME OF IMPLANT BILATERAL RENAL ACCESSORIES WERE EMBOLIZED. POST IMPLANT ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF ANEURYSM WITHOUT EVIDENCE OF ENDOLEAK. A CT PERFORMED ON (B)(6) 2021 SHOWED A POSSIBLE TYPE 2 ENDOLEAK "LIKELY DUE TO A NON-EMBOLIZED ACCESSORY LEFT RENAL", SAC WAS STABLE. HE HAD MULTIPLE INTERVENTIONS FOR A TYPE 2 ENDOLEAK WHICH LED TO A LAPAROSCOPIC LIGATION OF IMA AND MULTIPLE LUMBARS ON (B)(6) 2024. HE HAD A CV MRA ON (B)(6) 2025 THAT SHOWED SAC 7.2CM, THE REPORT ALSO STATED "RIGHT COMMON ILIAC- DISTAL SEGMENT IS ECTATIC, THE ILIAC LIMB OF AORTOILIAC STENT GRAFT EXTENDS INTO THE COMMON ILIAC ARTERY. INCOMPLETE APPOSITION OF THE DISTAL END OF THE STENT GRAFT." EXPLANT PERFORMED (B)(6) 2026. ON THE OP REPORT IT STATES 'SIGNIFICANT BLEEDING WAS NOTED FROM A DEFECT IN THE GRAFT FROM THE POSTERIOR MAIN BODY'" PATIENT OUTCOME: "NO INFO PROVIDED ON PATIENT. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: Clinical Endoleak

  MAUDE report 24967239 ↗
• InjuryApr 23, 2026Device Endoleak

  "I WAS MADE AWARE LAST NIGHT OF AN EXPLANT OF A TREO DEVICE, PHYSICIAN STATED THERE WAS TYPE 3 ENDOLEAK AND THE DECISION WAS MADE TO EXPLANT THE DEVICE. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 04/03/2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: AT THE TIME OF IMPLANT BILATERAL RENAL ACCESSORIES WERE EMBOLIZED. POST IMPLANT ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF ANEURYSM WITHOUT EVIDENCE OF ENDOLEAK. A CT PERFORMED ON (B)(6) 2021 SHOWED A POSSIBLE TYPE 2 ENDOLEAK "LIKELY DUE TO A NON-EMBOLIZED ACCESSORY LEFT RENAL", SAC WAS STABLE. HE HAD MULTIPLE INTERVENTIONS FOR A TYPE 2 ENDOLEAK WHICH LED TO A LAPAROSCOPIC LIGATION OF IMA AND MULTIPLE LUMBARS ON (B)(6) 2024. HE HAD A CV MRA ON (B)(6) 2025 THAT SHOWED SAC 7.2CM, THE REPORT ALSO STATED "RIGHT COMMON ILIAC- DISTAL SEGMENT IS ECTATIC, THE ILIAC LIMB OF AORTOILIAC STENT GRAFT EXTENDS INTO THE COMMON ILIAC ARTERY. INCOMPLETE APPOSITION OF THE DISTAL END OF THE STENT GRAFT." EXPLANT PERFORMED (B)(6)2026. ON THE OP REPORT IT STATES 'SIGNIFICANT BLEEDING WAS NOTED FROM A DEFECT IN THE GRAFT FROM THE POSTERIOR MAIN BODY'" PATIENT OUTCOME: "NO INFO PROVIDED ON PATIENT. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: Clinical Endoleak

  MAUDE report 24967238 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  "AFTER DEPLOYING THE LIMB AND REMOVAL OF THE DEVICE, THE NOSECONE HAD SEPARATED FROM THE DEVICE. PHYSICIAN WAS ABLE TO REMOVE THE NOSECONE FROM THE PATIENT." PATIENT OUTCOME: "PATIENT IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957799 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  "OCCLUSION: ON (B)(6) 2025, THE TREO STENT-GRAFT WAS IMPLANTED AND PREOPERATIVE CT SHOWED NO PROBLEMS. HOWEVER, ABOUT A YEAR LATER, CONTRAST-ENHANCED CT REVEALED OCCLUSION IN THE LEG STENT-GRAFT. THE PATIENT HAS NO DIFFICULTIES WALKING. THE PHYSICIAN IS CONSIDERING PERFORMING A FEMORAL-FEMORAL BYPASS PROCEDURE IN THE NEAR FUTURE. OPERATION TYPE: UNKNOWN BLOOD LOSS: UNKNOWN ANCILLARY DEVICES USED: TREO STENT-GRAFTS (28-B2-30-100U AND 28-L2-17-100U) UNKNOWN WHETHER IMAGE IS AVAILABLE PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA) UNKNOWN WHETHER ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC# (B)(4). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781558 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  "SUBJECT (B)(6) WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DURING THE 1-YEAR WINDOW FOR RIGHT LEG PAIN, BURNING PAIN IN RIGHT HIP AREA, FOLLOWED BY PAIN DOWN HIS LEG, AND THAT THE RIGHT LEG WAS COLD TO THE TOUCH WITH SYMPTOMS STARTING ON THE 14TH. A CT ON (B)(6) 2022 REFLECTED AN OCCLUSION OF THE RIGHT ILIAC ARTERY AND THE SUBJECT UNDERWENT REINTERVENTION VIA ARTERIAL THROMBOLYSIS WITH AN EKOS CATHETER IN THE RIGHT COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL ARTERIES." PATIENT OUTCOME: "SUBJECT WAS DISCHARGED HOME ON (B)(6) 2022. THE SUBJECT HAS HAD NO ENDOLEAKS NOR ANY FURTHER ADVERSE EVENTS TO DATE THROUGH 3-YEAR FOLLOW-UP IN 2025."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24746909 ↗

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