Reliant™ REL46 (UDI 00763000200947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000200947), received between Jul 8, 2019 and Jun 1, 2021 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 16, 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.

• MalfunctionJun 1, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  TWO RELIANT BALLOON WERE ATTEMPTED TO BE USED IN A UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, BALLOON BURST UPON INFLATION WHEN POST DILATING RIGHT LIMB OCCUR. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO DEVICE QUALITY ISSUE. IT WAS STATED THAT THE BALLOON APPEARS TO HAVE SEPARATED FROM SHAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913179 ↗
• MalfunctionJan 9, 2020Difficult to Insert; Difficult to Insert

  A RELIANT BALLOON WAS USED IN CONJUNCTION WITH A NON MDT SHEATH IN THE ENDOVASCULAR TREATMENT OF PATIENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE RELIANT BALLOON GOT STUCK INSIDE THE NON MEDTRONIC SHEATH, AND THAT THE SHEATH HAD TO BE REMOVED WITH THE BALLOON STILL INSIDE. THIS WAS THEN REPLACED WITH A NON-MDT DEVICE AND THE PROCEDURE COMPLETED SUCCESSFULLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569321 ↗
• DeathAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 55X70MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AS THE PHYSICIAN WAS BALLOONING THE PROXIMAL NECK WITH THE RELIANT BALLOON, THE PHYSICIAN FELT AS THOUGH THE AORTA ¿GAVE¿ WHILE INFLATING THE BALLOON. THERE WAS NO ISSUE NOTED AT THIS POINT AND FINAL ANGIO SHOWED NO ISSUE. HOWEVER, THE PATIENT COMPLAINED OF ABDOMINAL DISCOMFORT DURING RECOVERY. A CT SCAN SHOWED HEMATOMA OF THE LEFT KIDNEY. THE PHYSICIAN DECIDED TO BRING THE PATIENT BACK INTO THE OR TO EXPLORE THE ABDOMEN. THERE WAS SOME BLOOD NOTED IN THE ABDOMEN AND THE PHYSICIAN DECIDED TO PLACE A CUFF ETCF2828C49E ACROSS THE RENAL ARTERIES TO CONTROL BLEEDING. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A FRAGILE AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Death; Hematoma

  MAUDE report 8863628 ↗
• InjuryJul 8, 2019Device Damaged by Another Device; Device Damaged by Another Device

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER THE PLACEMENT OF THE STENT GRAFTS, BALLOONING WITH RELIANT BALLOONS WAS PERFORMED IN ALL AREAS AND KISSING BALLOONS WERE USED AT THE FLOW DIVIDER WITH WHAT APPEARED TO BE MORE FORCE THAN IS REQUIRED. ON FINAL ANGIOGRAM, THERE WAS CONTRAST FILLING THE ANEURYSM SAC AND AN EXTENSION WAS IMPLANTED TO GIVE 10-15MM MORE SEAL IN THE RIGHT COMMON ILIAC ARTERY TO ATTEMPT TO RESOLVE THIS. FURTHER ANGIOGRAM STILL SHOWED CONTRAST IN THE SAC AND WERE PERFORMED TO TRY RULE OUT A TYPE IA AND TYPE IB ENDOLEAK. ANGIOGRAM PERFORMED AT THE BODY OF THE STENT GRAFT ALSO SHOWED CONTRAST FILLING THE SAC. IT WAS CONSIDERED BY THE PHYSICIAN THAT THERE MAY HAVE BEEN A TYPE IIIB ENDOLEAK OR A TYPE II ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED BUT IF A TYPE IIIB ENDOLEAK MAY HAVE BEEN RELATED TO OVER BALLOONING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 8767998 ↗