Sentrant™ SENSH2428W (UDI 00643169792630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169792630), received between Aug 31, 2022 and Mar 15, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 88MM THORACOABDOMINAL ANEURYSM. THE PATIENT'S AORTA WAS NOTED AS DOUBLE S-SHAPED WITH SMALL ACCESS VESSELS AT THE ILIACS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT'S ILIACS WERE TOO SMALL TO PLACE THE VALIANT CAPTIVIA SO A CONDUIT WAS PLACED FOR ACCESS. ONCE THE WIRES WERE PLACED A SENTRANT SHEATH WAS PLACED INTO THE CONDUIT AND THE VAMF4036C150TU WAS IMPLANTED INTO THE PATIENT. POWER INJECTOR RUN WAS TAKEN TO CONFIRM PLACEMENT BEFORE DEPLOYMENT AND IT WAS NOTICED THAT CONTRAST WAS STAGNANT IN THE AORTA. THE PATIENT DETERIORATED AND CPR WAS ADMINISTERED AND THE GRAFT WAS REMOVED. THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF DEATH WAS ANATOMY RELATED DUE TO UNFORESEEN ANATOMICAL COMPLICATIONS INCLUDING THE SMALL ACCESS REQUIRING A CONDUIT, DOUBLE S-SHAPED AORTA, AND THE PATIENTS' BODY HABITUS WAS SMALL. THE PATIENT HAD COMPLEX AND DISEASED ANATOMY, AND IN AN ATTEMPT TO FIX THE THORACIC ANEURYSM, THE AN INFRARENAL ANEURYSM RUPTURED . NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 18912860 ↗
• MalfunctionAug 31, 2022Difficult to Insert; Difficult to Remove; Obstruction of Flow; Difficult to Insert; Difficult to Remove; Obstruction of Flow

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE TREATMENT OF A DISSECTION AND ENDOLEAK . 2 SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COULD NOT GET THE STENT GRAFT DELIVERY SYSTEM TO DELIVER THROUGH EITHER SHEATH. THE SAME ISSUE OCCURRED WITH BOTH THE 24F AND 26F SHEATH. IT APPEARED TO GET CAUGHT ON THE VALVE, IT WAS REPORTED. IT WAS ALSO DIFFICULT FOR THE PHYSICIAN TO REMOVE THE SHEATH EVEN IF IT WAS INSERTED A SMALL AMOUNT. THERE WAS NO DAMAGE TO THE DELIVERY SYSTEM AND THE PHYSICIAN DECIDED TO DELIVER THE STENT GRAFT WITHOUT A SHEATH.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327293 ↗