Sentrant™ SENSH2428W (UDI 00643169150362)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169150362), received between Feb 12, 2018 and Jul 3, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2018Difficult to Insert; Device Damaged by Another Device; Difficult to Insert; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO IMPLANT A VALIANT STENT GRAFT IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM FUSIFORM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THERE WERE TWO DOUBLE BACK CURVES IN THE AORTA AND THE GOTHIC ARCH. EXTREME VESSEL TORTUOSITY WAS NOTED IN THE THORACIC AORTA. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE A 24FR SENTRANT SHEATH WAS PLACED IN THE FEMORAL ARTERY TO ASSIST WITH DELIVERY OF ALL PLANNED STENT GRAFTS. THE 24FR SIZE WAS CHOSEN AS THE SIZE OF THE PRIMARY STENT GRAFT (VALIANT 40X40X200). IT WAS REPORTED THAT, DUE TO THE EXTREME TOURISTY OF THE ANATOMY THE PHYSICIAN INITIALLY ELECTED TO USE ANOTHER MANUFACTURER THORACIC STENT GRAFT TO TRY TO STRAIGHTEN OUT THE AORTA IN ORDER TO PASS THE VALIANT DEVICES. IT WAS REPORTED THAT THE PHYSICIAN WENT IN AND OUT OF THE SENTRANT SHEATH SEVERAL TIMES AND FOUND THE 24FR SENTRANT WAS VERY TIGHT. IT WAS REPORTED IT REQUIRED A LOT OF STRENGTH TO GET THE NON-MDR STENT GRAFT UP AND THAT THE NON-MDT STENT GRAFT COULD NOT BE DEPLOYED. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE VALIANT DELIVERY SYSTEM BUT AGAIN IT WAS REPORTED AS EXTREMELY DIFFICULT TO PASS THE VALIANT DELIVERY SYSTEM THROUGH THE SENTRANT SHEATH. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657846 ↗
• InjuryFeb 12, 2018Break; Difficult to Insert; Break; Difficult to Insert

  IMPLANTATION OF A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS ATTEMPTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. SEVERE CALCIFICATION WAS PRESENT, AND THE VESSEL DIAMETER WAS APPROX. 8MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE VALIANT DEVICE WAS ADVANCED THROUGH THE SENTRANT SHEATH, BUT COULD NOT REACH THE LESION. IT WAS NOTED THAT THE STRAIN RELIEF WAS CUT TO INSERT THE DEVICE DELIVERY SYSTEM BUT THIS ALSO FAILED. DELIVERY WAS ATTEMPTED A SECOND TIME, WITHOUT THE USE OF A SHEATH, BUT WAS UNSUCCESSFUL AS THE ACCESS VESSEL WAS DAMAGED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE DEVICE IN THE CONTRALATERAL ARTERY, HOWEVER THIS ALSO FAILED, AND THE PROCEDURE WAS ABORTED. IT WAS ALSO REPORTED THAT THE VALIANT DELIVERY SYSTEM WAS DIFFICULT TO INSERT THROUGH THE SENTRANT SHEATH. AFTER SEVERAL ATTEMPTS THE DEVICE WAS SUCCESSFULLY INSERTED, HOWEVER THE COATING OF THE VALIANT STENT GRAFT WAS REPORTEDLY REMOVED. THE PHYSICIAN ALSO NOTED AN ABNORMALITY WITH THE VALVE OF THE SHEATH AND THE VALIANT DEVICE DURING DELIVERY. THE PHYSICIAN COMMENTED THAT THE DEVICE DID NOT DELIVER AS NORMAL AND THIS MAY HAVE BEEN RELATED TO THE REMOVAL OF TH

  Patient problems: Perforation of Vessels

  MAUDE report 7262821 ↗