Relay Plus Thoracic Stent-Graft System 28-M334145302390URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761002192), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Premature Activation; Failure to Advance; Difficult to Advance; Premature Activation; Failure to Advance; Difficult to Advance

  "UNABLE TO ADVANCE THE INNER SHEATH: THE DELIVERY SYSTEM WAS ADVANCED INTO THE ARTERY AND THEN THE INNER SHEATH WAS ATTEMPTED TO BE ADVANCED OUT OF THE OUTER SHEATH. HOWEVER, THE INNER SHEATH WAS UNABLE TO PASS THROUGH THE UPPER PART OF THE CURVATURE OF THE AORTIC ARCH. PUSH-PULL MANIPULATION AND ROTATIONAL TORQUE WERE APPLIED, BUT THE INNER SHEATH WAS UNABLE TO BE PASSED THROUGH. THE PHYSICIAN CONSIDERED PERFORMING A PULL-THROUGH TECHNIQUE WITH THE DELIVERY SYSTEM KEPT IN THE AORTA, BUT DECIDED NOT TO PROCEED FURTHER AS IT WAS OBSERVED THAT THE INNER SHEATH HAD ALREADY BEEN PULLED DOWN SLIGHTLY, ALTHOUGH THE PROXIMAL STENT HAD NOT YET BEEN RELEASED. THE DELIVERY SYSTEM WAS ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE AID OF THE LARGE ACCESS VESSEL, ALTHOUGH THE INNER SHEATH HAD ALREADY BEEN ADVANCED OUT OF THE OUTER SHEATH. OBSERVATION OF THE REMOVED DELIVERY SYSTEM REVEALED THAT THE INNER SHEATH HAD BEEN PULLED DOWN SLIGHTLY AND THE BARE STENT WAS EXPOSED, AS SPECULATED. AS THE DESCENDING AORTA WAS SIGNIFICANTLY TORTUOUS IN AN S-SHAPE AND THE UPPER PART OF THE CURVED AORTIC ARCH WAS QUITE NARROW, A PULL-THROUGH TECHNIQUE WAS PERFORMED TO ALLOW THE DELIVERY SYSTEM OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327279 ↗