RelayPro Thoracic Stent-Graft SystemRecalls & reported problems across all models

We found 127 models of RelayPro Thoracic Stent-Graft System by Bolton Medical Inc. in the FDA's device registry (GUDID). Together they are named in 144 adverse event reports in the FDA's MAUDE database, received between May 1, 2024 and Sep 28, 2026 — classified as 13 deaths, 80 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Device Endoleak” (32 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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

RelayPro Thoracic 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. Apr 22, 2026Open, Classified

   Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

   Z-2160-2026 · Root cause: Under Investigation by firm · names 49 of these models · Recall details · FDA record ↗

2. Feb 22, 2024Completed

   The stent-graft inside the delivery system was the incorrect size.

   Z-1383-2024 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗

3. Dec 20, 2022Open, Classified

   The product may be shorter than packaging indicates

   Z-0998-2023 · Root cause: Labeling Change Control · names 59 of these models · Recall details · FDA record ↗

4. Dec 20, 2022Open, Classified

   The product may be shorter than packaging indicates

   Z-0997-2023 · Root cause: Labeling Change Control · names 33 of these models · Recall details · FDA record ↗

Most reported RelayPro Thoracic Stent-Graft System problems

RelayPro Thoracic Stent-Graft System models

127 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• RelayPro Thoracic Stent-Graft System 28-N4-34-154-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  3 recalls7 reports
• RelayPro Thoracic Stent-Graft System 28-N4-46-209-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls6 reports
• RelayPro Thoracic Stent-Graft System 28-N4-32-164-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-36-154-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-32-209-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-40-204-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-32-164-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-40-204-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death4 reports
• RelayPro Thoracic Stent-Graft System 28-N4-32-104-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 deaths3 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-209-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls3 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-154-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls3 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-209-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death3 reports
• RelayPro Thoracic Stent-Graft System 28-N4-36-109-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-154-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-36-199-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-259-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-36-154-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-40-154-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-32-209-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-199-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-34-109-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-30-164-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-42-159-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death1 report
• RelayPro Thoracic Stent-Graft System 28-N4-44-164-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-38-199-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-44-209-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-40-259-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-46-164-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-N4-36-199-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 death1 report
• RelayPro Thoracic Stent-Graft System 28-N4-42-204-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls1 report
• RelayPro Thoracic Stent-Graft System 28-M4-30-095-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-34-100-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-109-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-42-114-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-44-114-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-40-154-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-259-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-154-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-44-209-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-46-209-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-46-259-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  2 recalls0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-30-209-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall4 reports
• RelayPro Thoracic Stent-Graft System 28-M4-34-145-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall3 reports
• RelayPro Thoracic Stent-Graft System 28-N4-42-159-38U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall3 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-195-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• RelayPro Thoracic Stent-Graft System 28-M4-34-200-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• RelayPro Thoracic Stent-Graft System 28-M4-30-250-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death2 reports
• RelayPro Thoracic Stent-Graft System 28-M4-34-145-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-42-204-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 death2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-42-259-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• RelayPro Thoracic Stent-Graft System 28-N4-38-259-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall2 reports
• RelayPro Thoracic Stent-Graft System 28-M4-46-155-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-46-200-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-36-250-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-38-145-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-38-190-34U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-40-250-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-24-099-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-26-104-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-30-104-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-24-159-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-26-164-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-28-164-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-28-204-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-32-259-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-36-259-36U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-N4-32-259-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall1 report
• RelayPro Thoracic Stent-Graft System 28-M4-26-095-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-095-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-40-105-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-42-105-42U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-44-105-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-46-105-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-24-150-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-26-155-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-155-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-30-155-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-32-155-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-250-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-32-250-32U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-44-250-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-155-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-30-155-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-195-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-34-200-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-28-250-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-32-250-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-M4-44-250-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-28-104-28U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-40-114-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-46-114-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-46-164-46U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-26-204-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-30-209-30U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-24-259-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-44-259-44U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-28-164-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-30-164-26U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-44-164-40U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports
• RelayPro Thoracic Stent-Graft System 28-N4-28-204-24U

  System, Endovascular Graft, Aortic Aneurysm Treatment
  1 recall0 reports

Recent RelayPro Thoracic 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.

• MalfunctionSep 28, 2026Failure to Advance

  "Introduced a 24FR Gore dry seal on the patients right. Used ivus to determine proper landing zone in the arch. 36X250 Relay Pro was prepped with saline verified control knob was in position 1 and introduced in patient. Device was then removed to perform angiogram with contrast. Device was introduced to distal landing zone and Dr Chou started deploying graft by turning deployment grip away from him. The inner sheath advanced so that a little more than half of the stent was out of the outer sheath. At this point device would not advance anymore. Dr Chou pressed the disengagement button and tried to advance inner sheath, and there was no movement. At this point we noticed that the control knob was slightly out of the pocket in position one. Dr Chou adjusted that and we still had no luck in advancing device to the proper landing zone in the arch. At this point the device was put in position 2 and removed from patient. Dr Chou then proceeded to put 2 Gore Thoracic devices in and finish the case. The surgical tech had the relay pro on the back table and in going from position 2 and then position 1 and back to position 2 while turning deployment grip, the inner sheath finally was out of

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910583 ↗
• MalfunctionSep 26, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908445 ↗
• InjuryJun 26, 2026Device Endoleak

  "SUBJECT PRESENTED AN AORTIC ANEURYSM AND WAS TREATED WITH ONE RELAY PRO BARE STENT ON (B)(6) 2023. DURING THE 2-YEAR FOLLOW-UP CT IMAGING SHOWED A TYPE IB ENDOLEAK THAT THE PI DETERMINED NOT RELATED TO THE PROCEDURE AND UNDETERMINED IF RELATED TO THE DEVICE. THIS AE IS ONGOING." PATIENT OUTCOME: "PATIENT WILL BE MONITORED AND IMAGING WILL BE TAKEN AGAIN AT 3Y FOLLOW-UP."

  Patient problems: Clinical Endoleak

  MAUDE report 25636692 ↗
• MalfunctionMay 15, 2026Failure to Advance; Unintended Movement

  "BROKEN: THE RELAY PRO STENT GRAFT WAS USED FOR ONE-DEBRANCHING TEVAR. AFTER CONSTRUCTING THE DEBRANCH, THE DELIVERY SYSTEM WAS INSERTED THROUGH THE RIGHT COMMON FEMORAL ARTERY AND ADVANCED TO THE LEVEL OF THE AORTIC VALVE. AFTER ENSURING THAT THE CONTROLLER WAS IN THE "1" POSITION, THE DEPLOYMENT GRIP WAS ROTATED CLOCKWISE. THE PHYSICIAN FELT SOMETHING UNUSUAL BECAUSE HE HEARD A CRACKING SOUND AT THE BEGINNING OF THE ROTATION, BUT HE CONTINUED TO ROTATE THE GRIP. THE INNER SHEATH WAS ADVANCED UNTIL THE DEPLOYMENT GRIP ASSEMBLY PASSED THE WHITE ARROW MARKER WITH THE CONTROLLER IN THE "1" POSITION. HOWEVER, UNDER FLUOROSCOPY, THE INNER SHEATH DID NOT APPEAR TO ADVANCE OUT OF THE OUTER SHEATH TIP. UPON LOOKING AT THE COMMON FEMORAL ARTERY, THE PHYSICIAN FOUND THAT THE OUTER SHEATH HAD DETACHED FROM THE HANDLE BODY. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. ANOTHER RELAY PRO STENT GRAFT WITH THE SAME SPECIFICATIONS (AR-B3814534, LOT#2503110143) WAS INSERTED. THE STENT GRAFT WAS DEPLOYED AND IMPLANTED WITHOUT ISSUE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN COMMENTED THAT THE OUTER SHEATH COULD NOT HAVE PROPERLY FIT WITH THE HANDLE BODY. O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192082 ↗
• InjuryMay 14, 2026Device Slipped; Device Endoleak

  ENDOLEAK (TYPE IB OR IIIB) A PATIENT IN WHOM THE RELAY PRO STENT GRAFT WAS IMPLANTED WAS BROUGHT TO THE HOSPITAL DUE TO SUSPECTED AORTA RUPTURE. SINCE A TYPE 1B OR TYPE 3B CAUSED BY MIGRATION WAS SUSPECTED BASED ON A CT SCAN, AN EMERGENCY TEVAR WAS PERFORMED. ANGIOGRAPHY DURING THE PROCEDURE ALSO SHOWED AN ENDOLEAK FLOWING INTO THE ANEURYSM. THEREFORE, THE PHYSICIAN ADDITIONALLY IMPLANTED A CTAG STENT GRAFT (GORE). AFTER IMPLANTING THE CTAG STENT GRAFT, THE ENDOLEAK DISAPPEARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR: NO BLOOD LOSS, NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY, DELIVERY SYSTEM WAS DISCARDED BY USER, ((B)(4)). PATIENT OUTCOME: "NO HEALTH HAZARD TO THE PATIENT".

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25172568 ↗
• InjuryApr 9, 2026Device Endoleak

  "PRIOR TO TEVAR, THEY PLUGGED THE LSA AND DID A BYPASS TO THE CAROTID. PLAN TO LAND RELAYPRO TAPERFIT 38/28 X 250 MM INSIDE PREVIOUS THORAFLEX GRAFT 30/36. AFTER WE DELIVERED THE RELAYPRO INSIDE THE THORAFLEX, WE DID A RUN AND STILL HAD A LEAK. WE PLACED A SECOND STENT GRAFT MORE PROXIMALLY (CTAG --4040 MM) AND THERE WAS STILL A LEAK. FINALLY, PLACED A THIRD GRAFT MORE DISTAL (CTAG) 37/31 AND THE LEAK WAS GONE. WE ARE UNSURE WHAT THE ACTUAL CAUSE WAS BUT DR. (B)(6) THOUGHT THERE MIGHT BE A TEAR IN THE GRAFT." PATIENT OUTCOME: "NO PATIENT RELATED ISSUES."

  Patient problems: Clinical Endoleak

  MAUDE report 24829376 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  "PATIENT (B)(6), A CAUCASIAN FEMALE WITH AORTIC ANEURYSM (FUSIFORM SHAPE), EXPERIENCED AN EVENT OF BILATERAL ARM AND LEG WEAKNESS. THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2024 AND AN EXTENSION PROCEDURE WITH A RELAYPRO NBS ON THE (B)(6) 2025. FOR THE EXTENSION PROCEDURE THE VASCULAR ACCESS ACHIEVED VIA THE NATIVE LEFT FEMORAL ARTERY. AT THE END OF THE EXTENSION PROCEDURE AN INTENTIONAL ENDOLEAK TYPE IB WAS PRESENT. MEDICAL HISTORY INCLUDES: HYPERTENSION (CONTROLLED BY MEDICATION), ASA CLASS III - SUBJECT WITH SEVERE SYSTEMIC DISEASE, HYPOTHYROIDISM, TEMPORAL ARTERITIS, LEFT BREAST CANCER WITH LYMPH NODE REMOVAL AND CHEMO AND XRT, CURRENT SMOKER. SURGICAL HISTORY INCLUDES: NONE IS INDICATED IN THE EDC. EXTENSION DEVICE INFORMATION: PRODUCT TYPE: RELAYPRO NBS CATALOGUE NUMBER: 28-N4-32-259-32U LOT NUMBER: 2407100272 UDI NUMBER: (B)(4). SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE IS NO DEVICE DEFICIENCY. ON POST OPERATIVE DAY 322 AND POST EXTENSION DAY 49 (B)(6) 2025), PATIENT (B)(6) HAD A BILATERAL ARM AND LEG WEAKNESS (PT ARRIVED FROM OR AROUND 2130, IMMEDIATELY STROKE ALERTED DUE TO RIGHT

  Patient problems: Neuropathy

  MAUDE report 24781549 ↗
• InjuryMar 12, 2026Material Invagination; Material Deformation; No Apparent Adverse Event

  "ON FOLLOW UP CT THE DEVICE HAS INVAGINATED AT THE PROXIMAL EDGE. PRE AND POST OP IMAGING WILL BE PROVIDED." PATIENT OUTCOME: "THIS WAS FOUND ON ROUTINE F/U CT, PATIENT IS STABLE. NO ADDITIONAL TREATMENT HAS BEEN DONE YET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584378 ↗
• InjuryFeb 27, 2026Device Endoleak

  "SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE WAS NO DEVICE DEFICIENCY DURING OR AFTER THE INDEX OR EXTENSION PROCEDURE AND NO ENDOLEAKS PRESENT AT THE END OF EITHER PROCEDURE. ON POST OPERATIVE DAY 722 (INDEX)/284(EXTENSION), PATIENT (B)(6) HAD A CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. (B)(6) 2025, CTA REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT AND ENLA.... (CHARACTER LIMIT REACHED IN THE EDC SYSTEM). TREATMENT OF THE EVENT ON (B)(6) 2026 INCLUDED EXTENSION TEVAR VIA RIGHT CFA CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC A.... (CHARACTER LIMIT REACHED IN EDC SYSTEM). TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIV

  Patient problems: Clinical Endoleak

  MAUDE report 24473294 ↗
• InjuryFeb 27, 2026Device Endoleak

  "SITE DOCUMENTED IN ELECTRONIC DATA CAPTURE (EDC) SYSTEM THAT THERE WAS NO DEVICE DEFICIENCY DURING OR AFTER THE INDEX OR EXTENSION PROCEDURE AND NO ENDOLEAKS PRESENT AT THE END OF EITHER PROCEDURE. ON POST OPERATIVE DAY 722(INDEX)/284(EXTENSION), PATIENT 025001 HAD A CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. ((B)(6) 2025, CTA REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT AND ENLA.... (CHARACTER LIMIT REACHED IN THE EDC SYSTEM). TREATMENT OF THE EVENT ON (B)(6) 2026 INCLUDED EXTENSION TEVAR VIA RIGHT CFA CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC A.... (CHARACTER LIMIT REACHED IN EDC SYSTEM). TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIV

  Patient problems: Clinical Endoleak

  MAUDE report 24473013 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  "IMPLANTATION POSITIONING FAILURE / LEFT COMMON CAROTID ARTERY OCCLUSION: THE RELAYPRO WAS PLANNED TO BE IMPLANTED JUST BELOW THE LEFT SUBCLAVIAN ARTERY (ZONE 2). HOWEVER, THE PHYSICIAN IMPLANTED THE DEVICE MORE CENTRALLY THAN PLANNED, OCCLUDING THE LEFT COMMON CAROTID ARTERY. THE PROCEDURE WAS IMMEDIATELY CHANGED FROM ONE DEBRANCHING TEVAR TO TWO DEBRANCHING TEVAR TO RESTORE BLOOD FLOW. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY. NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. ((B)(4))" PATIENT OUTCOME: "THERE WAS NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428774 ↗
• MalfunctionFeb 18, 2026Mechanical Problem; Retraction Problem; Separation Failure

  "UNABLE TO DEPLOY THE STENT GRAFT: AFTER INSERTING THE DELIVERY SYSTEM INTO THE PATIENT, THE INNER SHEATH WAS SUCCESSFULLY ADVANCED WITH THE CONTROLLER IN THE "1" POSITION. AFTER THAT, THE INNER SHEATH WAS ATTEMPTED TO BE PULLED DOWN WITH THE CONTROLLER IN THE "2" POSITION. HOWEVER, THE INNER SHEATH COULD NOT BE PULLED DOWN, AND THE STENT-GRAFT COULD NOT BE DEPLOYED. THE STENT-GRAFT WAS ATTEMPTED TO BE DEPLOYED IN TWO WAYS: FIRST, BY ROTATING THE DEPLOYMENT GRIP; AND SECOND, BY USING MANUAL DEPLOYMENT. HOWEVER, THE STENT-GRAFT DID NOT DEPLOY EITHER WAY. ADDITIONALLY, THESE ATTEMPTS SHOWED A MOVEMENT OF THE ENTIRE DEVICE PULLING DOWN. THEREFORE, THE PHYSICIAN STOPPED MANIPULATING THE DEVICE. THEN, THE DEPLOYMENT GRIP WAS MANUALLY ADVANCED SLIGHTLY TO RELEASE TENSION, AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. SINCE THE DEVICE WAS DELIVERED THROUGH A DRYSEAL INTRODUCER SHEATH (GORE), NO DAMAGE WAS CAUSED TO THE ACCESS ARTERY. ANOTHER RELAY PRO STENT-GRAFT OF A DIFFERENT SIZE WAS THEN IMPLANTED. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. OPERATION TYPE: TEVAR. BLOOD LOSS: UNKNOWN. IMAGE AVAILABLE UPON REQUEST. PRE-CASE PLAN AVAILABLE UPON REQUEST. ADDITIONAL IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384028 ↗
• MalfunctionFeb 18, 2026Difficult or Delayed Separation

  "DIFFICULT TO RELEASE THE CLASP: THE STENT-GRAFT WAS DEPLOYED IN THE DESCENDING AORTA. THE APEX HOLDER KNOB WAS ATTEMPTED TO BE SLID TOWARD THE GUIDEWIRE LUER TO RELEASE THE APEX HOLDER. HOWEVER, THE APEX HOLDER KNOB COULD NOT BE MOVED AT ALL. AFTER PULLING THE APEX HOLDER KNOB WITH CONSIDERABLE FORCE FOR 5 TO 10 MINUTES, THE APEX HOLDER KNOB WAS FINALLY MOVED, AND THE APEX HOLDER COULD BE RELEASED TO PLACE THE STENT-GRAFT. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OPERATION TYPE: TEVAR BLOOD LOSS: NONE NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY PRE-CASE PLAN AVAILABLE UPON REQUEST ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST DELIVERY SYSTEM WAS DISCARDED BY USER ANCILLARY DEVICES USED: RELAY PRO: 28-N4-28-164-28U RADIFOCUS GUIDEWIRE LUMDERQUIST, COOK MEDICAL DRYSEAL FLEX INTRODUCER SHEATH, GORE MEDICAL (TC#BM260112070)" PATIENT OUTCOME: "NO HARM TO THE PATIENT'S HEALTH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384019 ↗
• InjuryFeb 18, 2026Device Endoleak

  "ENDOLEAK (SUSPECTED TYPE IIIB) AND ENLARGED ANEURYSM: A PATIENT WHO HAD THE RELAY PRO STENT-GRAFT IMPLANTED ON (B)(6) 2024, UNDERWENT A FOLLOW-UP CT SCAN THIS MONTH, WHICH REVEALED AN ENDOLEAK IN THE ANEURYSM AND ENLARGEMENT OF THE ANEURYSM. THE ENDOLEAK WAS SUSPECTED OF BEING TYPE IIIB. NO ENDOLEAK WAS NOTED DURING AND AFTER THE PROCEDURE. THE PATIENT WILL UNDERGO ADDITIONAL TEVAR THIS MONTH, USING A STENT-GRAFT OF A DIFFERENT MODEL. PHYSICIAN'S COMMENT ON CAUSALITY: CAUSAL RELATIONSHIP WITH THE PRODUCT CANNOT BE RULED OUT. OPERATION TYPE: TEVAR NO BLOOD LOSS COMPLICATIONS: UNKNOWN MEDICAL HISTORY: UNKNOWN. NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC# (B)(4). PATIENT OUTCOME: "THE PATIENT'S OUTCOME IS UNKNOWN."

  Patient problems: Clinical Endoleak

  MAUDE report 24384018 ↗
• InjuryFeb 14, 2026Material Invagination; Material Deformation; No Apparent Adverse Event

  "ON FOLLOW UP CT, THE DEVICE HAS INVAGINATED AND IS NO LONGER SEALING THE DISSECTION. PRE AND POST OP IMAGING WILL BE PROVIDED." PATIENT OUTCOME: "THIS WAS FOUND ON ROUTING F/U CT, PATIENT IS STABLE. NO ADDITIONAL TREATMENT HAS BEEN DONE YET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340442 ↗

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