Sentrant™ SENSH2028W (UDI 00643169150348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169150348), received between May 2, 2017 and Aug 11, 2017 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2017Difficult To Position; Device Damaged by Another Device; Difficult To Position; Device Damaged by Another Device

  AN ENDURANT STENT GRAFT AORTIC CUFF WAS IMPLANTED PROPHYLACTICALLY IN A PATIENT DURING AN ENDOVASCULAR TREATMENT FOR A TYPE II ENDOLEAK. THE PATIENT HAD BEEN LOST TO FOLLOW UP. APPROXIMATELY FOUR YEARS AND TWO MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THE PATIENT HAD A LIKELY PROXIMAL TYPE I ENDOLEAK WITH A SEAL ZONE REGRESSION OF A COUPLE OF MILLIMETERS. THE PHYSICIAN DETERMINED THE PROXIMAL TYPE I ENDOLEAK TO BE DUE TO PROGRESSIVE PROXIMAL AORTIC NECK DILATATION. THE ANEURYSM MEASURED 13 CM IN DIAMETER. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT II AORTIC STENT GRAFT CUFF. IT WAS REPORTED THAT DURING THE SECONDARY PROCEDURE, 20FR SENTRANT SHEATH WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED BARE METAL STENT HOWEVER UNABLE TO BE ADVANCED TO INTENDED LOCATION. THE PHYSICIAN ELECTED TO REMOVE THE 20FR SENTRANT SHEATH AND MODIFIED THE CATHETER, CUTTING OFF A PORTION OF THE CATHETER. THE 20FR SENTRANT SHEATH WAS REINSERTED IN TO THE PATIENT AND THE ENDURANT AORTIC CUFF DELIVERY SYSTEM AND A FLUSH CATHETER WERE ADVANCED TO THE INTENDED LANDING ZONE. THE PHYSICIAN STATED THAT DURING DELIVERY OF THE ENDURANT AORTIC CUFF THERE WAS EXTREME DRAG, A FEW STENT RINGS WERE EXPOSED HOWEVER

  Patient problems: Injury

  MAUDE report 6787941 ↗
• InjuryJul 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT AUI STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53X52MM DIAMETER ABDOMINAL AORTIC ANEURYSM UTILIZING A SENTRANT SHEATH. THE PROXIMAL LEFT EXTERNAL ILIAC ARTERY WAS 6MM IN DIAMETER. THE PROXIMAL AORTIC NECK MEASURED 29 MM TO 31 MM IN DIAMETER ALONG A 10 MM LENGTH. IT WAS REPORTED THAT THE RIGHT COMMON FEMORAL ARTERY WAS EXPOSED AND CONTROLLED WITH VESSEL LOOPS. THE ARTERY WAS ACCESSED WITH AN 18G NEEDLE AND WIRES AND CATHETERS WERE USED TO GAIN ACCESS INTO THE AORTA. THE PHYSICIAN PLACED A 20FR SHEATH OVER A LUNDERQUIST WIRE INTO THE INFRARENAL AORTA. ONCE THE SHEATH WAS IN PLACE THE ENDURANT AUI WAS PREPPED. THE PHYSICIAN ACCESSED THE SHEATH WITH A WIRE AND PIG TAIL CATHETER. AN AORTOGRAM WAS PERFORMED AND THE RENAL ARTERIES WERE IDENTIFIED. THE PIG TAIL CATHETER WAS REMOVED AND REPLACED WITH THE AUI. THE AUI WAS PLACED WAS BELOW THE RENAL ARTERIES WITH NO ISSUES. THE 20FR SHEATH WAS PULLED DISTAL TO THE HYPOGASTRIC AND AN ANGIOGRAM DONE TO MARK THE LOCATION OF THE LEFT COMMON ILIAC ARTERY. AN ENDURANT LIMB WAS PLACED IN PROPER POSITION. THE AUI AND LIMB WERE BALLOONED WITH A RELIANT WITH NO ISSUE. AT THIS TIME THE PATIENT STARTED H

  Patient problems: Perforation of Vessels

  MAUDE report 6704385 ↗
• MalfunctionMay 2, 2017Break; Break

  A SENTRANT SHEATH WAS ATTEMPTED TO BE USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE TIP OF THE DILATOR WAS DAMAGED IN THE PACKAGING. THE SURGEON NOTICED THIS WHILE PREPPING THE DEVICE. THE DILATOR WAS SNAPPED IN PLACE WHEN THE PACKAGE WAS OPENED AND THERE WAS NO VISIBLE DAMAGE TO THE BOX OR CONTAINER. ANOTHER SHEATH WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6538038 ↗