Thoraflex™ Hybrid THP2830X100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881026718), received between May 22, 2024 and Apr 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON POST OPERATIVE DAY 4 ((B)(6) 2025), SITE REPORTED AN ADVERSE EVENT (AE) OF FALSE LUMEN THROMBOSED, WITH IMPROVED EXPANDED TRUE LUMEN EXTENDING FROM THE PROXIMAL ASCENDING AORTA TO THE PROXIMAL ABDOMINAL AORTA, AT THE LEVEL OF L1 VERTEBRAL BODY. PATIENT OUTCOME: THE THROMBOSIS IS ONGOING, UNRESOLVED WITH NO TREATMENT AND IS ONGOING AT TIME OF REPORTING. THE ADVERSE EVENT IS CONSIDERED MODERATE IN SEVERITY. THE SUBJECT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS INCLUDE ASPIRIN, LABETALOL AND NICARDIPINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21897697 ↗
• InjuryFeb 18, 2025Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  PATIENT IS PART OF CLINICAL TRIAL (B)(6). THE ONLY INFORMATION THAT SITE HAVE ENTERED INTO THE EDC (ELECTRONIC DATA CAPTURE SYSTEM) IS THE EVENT TERM, START DATE OF THE EVENT. THE SITE WILL BE REQUESTED TO UPDATE THE ADVERSE EVENT PAGE AND ANY RELEVANT PAGES IN THE EDC. ON (B)(6) 2024 THE PATIENT DEVELOPED THE MEDICAL EVENT OF A STENT GRAFT INDUCED NEW ENTRY (SINE) THIS REPORT IS BEING SUBMITTED AS FOLLOW UP # 1 FOR MANUFACTURING REPORT 9612515-2025-00017 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

  Patient problems: Insufficient Information; Rupture

  MAUDE report 21397946 ↗
• InjuryAug 28, 2024Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  EVENT REPORTED: 06 AUG 24. IMPLANT DATE: (B)(6) 2024. EXTEND-OO1 (NCT05639400) POST MARKET APPROVAL STUDY. EVENT DETAILS AS REPORTED, THE PATIENT THROMBUS IN ASCENDING AORTA SEEN WITH COMPRESSION INTO LEFT ATRIUM. THE THROMBUS OCCURRED OF (B)(6) 2024. THORAFLEX HYBRID WAS IMPLANTED ON (B)(6) 2024. NO DISTAL SEAL WAS INTENDED DUE TO A PLANNED EVAR EXTENSION AND NO DISTAL SEAL WAS OBTAINED. NO ENDOLEAK WAS PRESENT AT THE END OF THE PROCEDURE. DELIVERY OF THE THORAFLEX HYBRID WAS SUCCESSFUL, DEPLOYED IN PLANNED LOCATION AND WITHDRAWAL OF DELIVERY SYSTEM WAS SUCCESSFUL. NO DEVICE DEFICIENCIES OCCURRED DURING THE INDEX TH PROCEDURE. THE CLINICIAN/SITE HAVE REPORTED THIS EVENT AS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PRE-EXISTING CONDITION; RELATIONSHIP TO PROCEDURE NOT PROVIDED AS YET. DURING THEIR REGULAR REVIEW OF EXTEND ADVERSE EVENTS, THE STUDY MEDICAL MONITOR HAS REVIEWED AND MARKED THIS EVENT AS POSSIBLY RELATED TO THE DEVICE AND POSSIBLY RELATED TO PROCEDURE. THE SITE HAVE INDICATED THAT NO ACTION HAS BEEN TAKEN TO TREAT THE ADVERSE EVENT AT THIS TIME. PATIENT CURRENT STATUS IS UNRESOLVED AT THIS TIME.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 20083382 ↗
• InjuryMay 22, 2024Obstruction of Flow; Obstruction of Flow

  AS REPORTED: THE PATIENT HAD A SURGERY FOR A TOTAL ARCH REPAIR. THE PHYSICIAN SAID HIS TRUE LUMEN WAS OCCLUDED AND THEY WERE GOING BACK TO EXTEND THE THORAFLEX IN A LAST-DITCH EFFORT CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) WAS PERFORMED IT WAS CLEAR THAT A DISTAL NEW STENT ENTRY TEAR WAS PRESENT. THE PATIENT UNDERWENT ANOTHER SURGERY TO EXTEND THE THORAFLEX AND SEAL OFF THE ANEURYSM USING A COOK MEDICAL DISSECTION GRAFT (TX2), AS WELL AS PERFORM A THROMBECTOMY ON THE SUPERIOR MESENTERIC ARTERY, AS IT WAS COMPLETELY THROMBOSED. A COOK MEDICAL DISSECTION STENT WAS PLACED FROM THE COOK MEDICAL TX2 THORAFLEX EXTENSION TO THE BIFURCATION AND A KNICKER BOCKER TECHNIQUE WAS PERFORMED IN THE ZDEG (ZENITH DISSECTION ENDOVASCUALR GRAFT) USING A 46MM CODA BALLOON. THE DISSECTION WAS THEN STABILIZED USING THE SAME CODA BALLOON, THROUGH THE ZDES (ZENITH DISSECTION ENDOVASCULAR STENT). THE SUPERIOR MESENTERIC ARTERY, THE RIGHT RENAL ARTERY, AND LEFT RENAL ARTERY WERE STENTED SO ALL VITAL ORGANS COULD BE PERFUSED. THE LOWER EXTREMITIES AT THIS TIME ALSO WERE NOT BEING PERFUSED, THEREFORE GORE EXCLUDER LIMBS WERE PLACED AS "KISSING STENTS" FROM THE BILATERAL HYPOGASTRIC ARTERIES TO THE INFRARENAL AO

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 19368647 ↗