Sentrant™ SENSH1628W (UDI 00643169150324)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169150324), received between Apr 13, 2017 and Feb 5, 2018 — classified as 2 deaths, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

• MalfunctionFeb 5, 2018Component Missing; Packaging Problem; Component Missing; Packaging Problem

  A SENTRANT WAS BEING PREPARED TO BE USED FOR A PATIENT IN AN EMERGENCY PROCEDURE. IT WAS REPORTED THAT A DILATOR WAS NOT PACKED IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER PRODUCT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 7241053 ↗
• DeathSep 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE MAIN BODY WAS PLACED ON THE RIGHT SIDE. A 16 FR SENTRANT SHEATH WAS THEN INSERTED ON THE LEFT TO MAINTAIN ACCESS FOR GATE CANNULATION FOR THE CONTRALATERAL LIMB. THE PHYSICIAN THEN REPORTEDLY PULLED THE SHEATH BACK AND LOST ACCESS IN THE TORTUOUS ILIAC ARTERY. THEY THEN ATTEMPTED TO INSERT THE SHEATH WITH A STIFF WIRE IN PLACE, BUT THE ILIAC ARTERY BECAME PERFORATED AND THE PATIENT BECAME UNSTABLE. THEY FINISHED PLACING THE IPSILATERAL SIDE OF THE MAIN BODY AND PLACED A RELIANT BALLOON ABOVE THE CELIAC ARTERY TO STABILIZE BLOOD PRESSURE. THE PHYSICIAN THEN OPTED TO PERFORM AN OPEN CONVERSION AND THE PHYSICIAN LEFT THE SHEATH IN THE ILIAC ARTERY UNTIL THE PROXIMAL REPAIR WAS COMPLETED. THE STENT GRAFT WAS PARTIALLY EXPLANTED AND AN AORTO-BIFEMORAL BYPASS GRAFT WAS SEWN IN AND TIED TO THE FEMORAL ARTERIES BILATERALLY. THIS REPORTEDLY RESOLVED THE EVENT AT THE TIME; HOWEVER, THE PATIENT EXPIRED LATER THAT EVENING FROM COMPARTMENT SYNDROME. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SPECIFICALLY, TORTUOS

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6899927 ↗
• DeathApr 13, 2017Difficult to Insert; Difficult to Insert

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM AND A 2.5 CM IN DIAMETER RIGHT ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION IN THE VESSELS. IT WAS REPORTED THAT THE RIGHT AND LEFT COMMON FEMORAL ARTERIES WERE EXPOSED AND CONTROLLED SECURED WITH A VESSEL LOOPS. USING AN 18GAUGE NEEDLE TO GAIN ACCESS INTO THE RIGHT COMMON FEMORAL VASCULAR ANATOMY. ANOTHER MANUFACTURER¿S 7FR SHEATH WAS PLACED AND A GLIDE WIRE WITH ANOTHER MANUFACTURER¿S CATHETER WERE ADVANCED TO THE SUPRARENAL AORTA. THE GLIDE WIRE WAS EXCHANGED FOR ANOTHER GUIDE WIRE. THE CATHETER AND SHEATH WERE REMOVED AND A SENTRANT 12FR SHEATH WAS ADVANCED TO THE EXTERNAL ARTERY. THE SENTRANT 12FR SHEATH WAS UNABLE TO BE ADVANCED INTO THE RIGHT COMMON ILIAC DUE TO THE CALCIUM. ANOTHER MANUFACTURER¿S DILATOR WAS USED TO DILATE THE COMMON AND EXTERNAL ILIAC ARTERIES. POST DILATATION THE PHYSICIAN ATTEMPTED TO ADVANCE THE SENTRANT 12FR SHEATH AGAIN WITHOUT SUCCESS. THE PHYSICIAN ELECTED TO ACCESS THE LEFT COMMON FEMORAL ARTERY. A 18GA NEEDLE WAS USED ALONG WITH SENTRANT 16FR SHEATH WAS USED TO GAIN ACCESS INTO THE

  Patient problems: Death; Myocardial Infarction

  MAUDE report 6491944 ↗