Sentry IVC Filter 146155-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05391529380069), received between Apr 25, 2019 and Aug 7, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (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. How this data works · Data updated Oct 13, 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 7, 2020Use of Device Problem; Malposition of Device; Difficult to Open or Close; Use of Device Problem; Malposition of Device; Difficult to Open or Close

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SENTRY IVC FILTER FOR DVT THROUGH THE RIGHT COMMON FEMORAL VEIN. A VENOGRAM WAS PERFORMED PRIOR TO PLACEMENT. THE DEVICE WAS DEPLOYED IN THE IVC, INFRA RENAL AND THE DISTAL PORTION OF THE FILTER DID NOT OPEN AS EXPECTED. THE NEXT DAY A CTA WAS PERFORMED AND REVEALED THAT THE DISTAL PART OF THE FILTER WAS OUTSIDE OF THE IVC. THE PATIENT IS STABLE AND THE PHYSICIAN IS PLANNING POSSIBLE INTERVENTION. IT WAS FURTHER REPORTED THAT THIS EVENT WAS A RESULT OF USE ERROR AND NOT DEVICE FAILURE. THE PHYSICIAN DID NOT USE A GUIDEWIRE WHILE ADVANCING THE SHEATH 3CM FORWARD RIGHT BEFORE THE FILTER WAS DEPLOYED. THE MOVEMENT OF THE SHEATH RESULTED IN PERFORATION OF THE IVC. VENOGRAM IMAGING SHOWS THE TOP CROWN WAS CONSTRAINED DUE TO BEING EXTRAVASCULAR. THE PATIENT WAS TREATED AT A DIFFERENT INSTITUTION WHERE THE FILTER WAS SUCCESSFULLY EXPLANTED.

  Patient problems: No Code Available; Perforation of Vessels

  MAUDE report 10382129 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS DERIVED FROM A LITERATURE REVIEW OF FILTER-RELATED COMPLICATIONS PRESENTED IN "INFERIOR VENA CAVA FILTER EVALUATION AND MANAGEMENT FOR THE DIAGNOSTIC RADIOLOGIST: A COMPREHENSIVE REVIEW INCLUDING INFERIOR VENA CAVA FILTER-RELATED COMPLICATIONS AND PRESERVE TRIAL FILTERS" ARTICLE BY AHMED ET AL 2019. IN FILTER-ASSOCIATED COMPLICATIONS SECTION, A CORONAL CONTRAST ENHANCED COMPUTED TOMOGRAPHY IMAGE DEMONSTRATES ACUTE THROMBOTIC OCCLUSION OF A BTG SENTRY CONVERTIBLE FILTER. THROMBUS IS ALSO NOTED EXTENDING CEPHALAD TO THE CONICAL APEX OF THE FILTER.

  Patient problems: Thrombosis

  MAUDE report 9316015 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A VENOGRAM ON A PATIENT WHO HAD A SENTRY IVC FILTER PLACED PREVIOUSLY IN HIS LAB. THE INITIAL VERBATIM DESCRIPTION WAS; "THIS DEVELOPED CLOT IN THE FILTER AFTER IT PARTIALLY OPENED AND YES IT'S OPEN AND I DID SOME TPA". THE PHYSICIAN PROVIDED AN IMAGE OF THE VENOGRAM. THE VENOGRAM SHOWED THAT THE SENTRY HAD BIO-CONVERTED AND THAT THERE WAS A FILLING DEFECT (REPORTED AS CLOT) IN ADJACENT TO 2-3 OF THE FILTER'S ARMS. THE DATE THE SENTRY WAS PLACED WAS NOT REPORTED. DURING FOLLOW-UP CONVERSATIONS, THE PHYSICIAN STATED THAT, AS PER HIS PRACTICE, HE HAND INJECTS 4 MG OF TPA, IMPLANT FILTER, THEN DISCHARGE THE PATIENT WITH A PRESCRIPTION FOR ELIQUIS. IT IS NOT KNOWN IF THIS PATIENT FILLED THE PRESCRIPTION. THE INDICATION FOR FILTER PLACEMENT IN THIS PATIENT IS UNKNOWN. THE PHYSICIAN ALSO STATED THAT HE PERFORMS ROUTINE FOLLOW-UP FOR ALL OF HIS IVC FILTER PATIENT'S VENOGRAMS ON ALL OF HIS IVC FILTER PATIENTS WITHIN 2-3 POST-IMPLANT. THIS VENOGRAM WAS NOT PERFORMED DUE TO ANY NEW THROMBOEMBOLIC RISK FACTORS. A FOLLOW-UP VENOGRAM WAS PERFORMED ON (B)(6) 2019 VIA JUGULAR ACCESS. A CATHETER WAS PLACED THROUGH THE SENTRY IVC FILTER TO PERFORM THE VE

  Patient problems: No Code Available

  MAUDE report 8550275 ↗