Sentrant™ SENSH2228W (UDI 00643169150355)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169150355), received between Mar 21, 2017 and Nov 2, 2017 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2017Difficult to Insert; Difficult to Insert

  A SENRANT SHEATH WAS CONDUIT FOR A VALIANT STENT GRAFT SYSTEM USED FOR THE ENDOVASCULAR TREATMENT OF A 60 MM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT SOME DIFFICULTIES WERE ENCOUNTERED DURING THE ADVANCEMENT OF THE SENTRANT SHEATH AND IN GAINING ACCESS TO THE COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE INSERTION DIFFICULTIES WAS ANATOMY RELATED, DUE TO TISSUE DEGRADATION AND VESSEL DIAMETER. IT WAS ALSO REPORTED THAT POST INDEX PROCEDURE BUT ON THE SAME DAY, A RUPTURED ILIAC ARTERY WAS DISCOVERED. THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER¿S SELF-EXPANDING STENTS, AND COVERED STENTS TO EXCLUDE THE VESSEL RUPTURE. POST INDEX PROCEDURE THE PATIENT ALSO SUFFERED A CVA/STROKE. AS PER THE PHYSICIAN, THE CAUSE OF THE STROKE CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 6995636 ↗
• DeathAug 1, 2017Break; Difficult to Insert; Device Damaged by Another Device; Break; Difficult to Insert; Device Damaged by Another Device

  A SENTRANT SHEATH WAS USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ANOTHER MANUFACTURER¿S STENT GRAFT WAS IMPLANTED THE PATIENT USING A SENTRANT SHEATH. A 22 FR SHEATH WAS INSERTED IN TO A PREVIOUSLY PLACED ABDOMINAL Y-SHAPED STENT GRAFT, THE LIMB OF WHICH MEASURED 8MM. IT WAS NOTED THAT RESISTANCE WAS FELT WHEN CROSSING THIS AREA. IT WAS ALSO NOTED THAT THIS WAS AN OFF-LABEL USE OF THE SHEATH. THE FIRST OF TWO STENT GRAFTS FROM ANOTHER MANUFACTURE WERE THEN INSERTED INTO THE SHEATH. THE FIRST WAS DELIVERED WITH RESISTANCE BUT WAS IMPLANTED NORMALLY. THE SECOND STENT GRAFT ALSO ENCOUNTERED RESISTANCE AND COULD NOT BE FULLY DEPLOYED. IT WAS PARTIALLY DEPLOYED. BALLOONING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DEVICE COULD NOT BE WITHDRAWN SO THE PATIENT WAS CONVERTED TO A THORACOTOMY. THE PATIENT WAS OPENED AND THE PHYSICIAN NOTED THAT THE COIL BRAID OF THE SENTRANT DEVICE WAS ENTANGLED WITH THE OTHER MANUFACTURER¿S STENT, WHICH PREVENTED IT FROM DEPLOYING. A VESSEL PROSTHESIS WAS IMPLANTED AND THE INCISION WAS CLOSED. AFTER A FEW HOURS IN THE ICU THE PATIENT EXPIRED. THE PHYSICIAN STATED THAT THE PATIENT WAS ADVANCED IN AGE A

  Patient problems: Death

  MAUDE report 6756268 ↗
• MalfunctionJun 7, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A SENTRANT SHEATH WAS SELECTED AND USED FOR THE ENDOVASCULAR TREATMENT IN A PATIENT. IT WAS REPORTED THAT THE OUTER BOX LABEL INDICATED THAT THIS WAS A SENTRANT 22 FR SHEATH. HOWEVER, THE INNER POUCH PACKAGE INDICATES IT IS A SENTRANT 26FR SHEATH. THE ACTUAL SHEATH WAS A SENTRANT 22 FR. THE SENTRANT 22 FR SHEATH WAS SUCCESSFULLY USED IN THE PATIENT, AS THE DISCREPANCY IN THE LABELING WAS DISCOVERED DURING THE INVENTORY FOR BILLING TO THE PATIENT¿S CHART AFTER THE SENTRANT SHEATH WAS USED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO THE DEVICE LABELING. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6619804 ↗
• InjuryMar 21, 2017Difficult to Insert; Difficult To Position; Difficult to Insert; Difficult To Position

  A SENTRANT SHEATH WAS USED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 300 MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED THAT A PERCUTANEOUS APPROACH WAS PERFORMED FROM THE LEFT GROIN. ANOTHER MANUFACTURER¿S SUTURES WERE PLACED AND GUIDEWIRE ACCESS WAS OBTAINED. THE FIRST MAIN VALIANT 32 X 32 X 200 STENT GRAFT WAS IMPLANTED WITHOUT ANY SEQUELAE. A 22FR SENTRANT SHEATH WAS INSERTED TO BACKFILL THE HOLE, HOWEVER WAS MET WITH RESISTANCE AND UNABLE TO ADVANCE TO THE INTENDED LANDED LOCATION. THE 22FR SENTRANT SHEATH WAS REMOVED FROM THE PATIENT. A SECOND VALIANT 34 X 30 X 150 STENT GRAFT WAS IMPLANTED. THE 22 FR SHEATH WAS REINSERTED AGAIN TO BACKFILL THE HOLE, HOWEVER WAS MET WITH RESISTANCE AND UNABLE TO ADVANCE TO THE INTENDED LANDED LOCATION. AN ANGIOGRAM WAS PERFORMED AND THE TEVAR FOR DISSECTION WAS SUCCESSFULLY COVERED. THE PHYSICIAN REMOVED THE 22 SENTRANT SHEATH FROM THE PATIENT. A RETROGRADE ANGIOGRAM WAS PERFORMED THROUGH THE LEFT GROIN AND EXTRAVAGATION WAS NOTED DUE TO A PERFORATION OF THE LEFT COMMON ILIAC ARTERY (LCIA). THE PHYSICIAN INSERTED A 10 MM ANOTHER MANUFACTURER¿S BALLOON THROUGH THE LEFT GROIN TO THE PROXIMAL LCIA. THEN ANOTHER MANUFACTURER¿S 8 X 10 CM C

  Patient problems: Perforation of Vessels

  MAUDE report 6421642 ↗