Sentrant™ SENSH1828W (UDI 00643169792609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169792609), received between Feb 22, 2021 and Aug 2, 2024 — classified as 3 deaths, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2024Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  A SENTRANT SHEATH (B)(6) WAS USED AS A CONDUIT DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, WHEN INTRODUCING THE SHEATH INTO THE PATIENT, THE VALVE CAME LOOSE, CAUSING A LEAK FROM VALVE. THE SENTRANT SHEATH WAS REPLACED WITH AN ALTERNATIVE MEDTRONIC SENTRANT SHEATH (00182574) OF THE SAME SIZE, AND PROCEDURE CONTINUED SUCCESSFULLY WITHOUT FURTHER ISSUE. PER THE PHYSICIAN THE CAUSE HEMOSTASIS VALVE LEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19891955 ↗
• MalfunctionJul 2, 2024Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS INTENDED TO BE USED AS A CONDUIT DURING THE IMPLANT OF A TRANSCATHETER EVOLUT PRO PLUS 34 BIOPROSTHETIC VALVE. THE PATIENT WAS NOTED TO HAVE COMPLEX AND CALCIFIED BICUSPID ANATOMY. THE SENTRANT SHEATH WAS NOTED TO BE DAMAGED WHEN IT WAS REMOVED FROM THE PATIENT AFTER PRE-DILATATION. AS THE DAMAGE COULD CAUSE RISK TO THE PATIENT'S ARTERIES AND THE DEVICE WOULD NEED TO BE REINTRODUCED INTO THE PATIENT, A NEW SENTRANT WAS USED TO CARRY OUT THE PROCEDURE. THE CAUSE OF THE SENTRANT DAMAGE WAS NOT PROVIDED. AN INFOLD OF THE EVOLUT VALVE OCCURRED DURING THE PROCEDURE BUT IT WAS CONFIRMED THE SENTRANT SHEATH DID NOT CONTRIBUTE TO THIS EVENT. A NEW PRE-DILATION WAS PERFORMED WITH A 25 BALLOON AND THEN THE PROSTHESIS WAS IMPLANTED WITHOUT COMPLICATIONS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653810 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE IN THE IMPLANT OF A MEDTRONIC HEART VALVE . IT WAS REPORTED THAT TWO DAYS  POST THE IMPLANT PROCEDURE , THE PATIENT REPORTED RIGHT LOWER QUADRANT ABDOMINAL PAIN AND SUBSEQUENTLY DEVELOPED A DROP IN HEMOGLOBIN. A CT OF THE ABDOMINAL AND PELVIS WAS OBTAINED AND SHOWED A RIGHT SIDED MODERATELY SIZED RETROPERITONEAL HEMATOMA EXTENDING TO THE PELVIS TO THE MID ABDOMEN MEASURING 8 X 6CM.  PER THE CT CHEST RESULT, THERE IS HEAVY CALCIFICATION OF THE AORTIC VALVE LEAFLETS, WHICH MAY UNDERLIE HEMODYNAMICALLY SIGNIFICANT AORTIC STENOSIS. A CT A FURTHER TWO DAYS LATER REVEALED A SIMILAR TO SLIGHT DECREASE IN SIZE WITH NO NEW OR ENLARGING HEMATOMA. THE PATIENTS HEMOGLOBIN AT BASELINE WAS 9.5 G/DL, THEN 7.2 AND THEN 7.8 G/DL. THIS EVENT PROLONGED THE PATIENTS HOSPITISATION.  FOR A CAUSE OF THE RETROPERITONEAL HEMATOMA IT WAS NOTED PER SITE¿S ASSESSMENT, THE PULMONARY INTERSTITIAL EDEMA HAD A CAUSAL RELATIONSHIP WITH TAVI PROC, VALVE AND SHEATH. ANATOMY WAS POSSIBLY RELATED. THE HEMATOMA RESOLVED SIX DAYS LATER.  THE SITE ASSESSED THE HEMATOMA EVENT AS HAVING A CAUSAL RELATIONSHIP TO THE SHEATH AND PROCEDURE. THE SPONSOR ASSESSED IT AS NOT RELATE

  Patient problems: Anemia; Hematoma; Pain

  MAUDE report 16582661 ↗
• MalfunctionMar 3, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A SENTRANT SHEATH WAS USED AS A CONDUIT FOR A EVOLUT DEVICE DURING A TAVR PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE THE VALVE ASSEMBLY WAS CHECKED AND IT WAS OK. AFTER THE FIRST IMPLANT ATTEMPT A RECAPTURE WAS PERFORMED TO PERFORM THE REPOSITIONING. DURING THE SECOND POSITIONING ATTEMPT, IT WAS VERIFIED THAT THE VALVE WAS INFOLDING, THAT IS, WITH A DENTED PART THAT DID NOT EXPAND. SEEING THE SITUATION OF THE PROSTHESIS, THE PHYSICIAN CONCLUDED THAT THE REPLACEMENT OF THE PROSTHESIS AND THE DELIVERY WOULD BE THE BEST OPTION. AFTER THE REPLACEMENT THE IMPLANT WAS SUCCESSFUL. PER THE PHYSICIAN THE CAUSE OF THE INFOLDING IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16476827 ↗
• DeathJun 9, 2022Positioning Problem; Positioning Problem

  TWO SENTRANT SHEATHS WERE USED DURING AN AORTIC HEART VALVE PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, AFTER DISSECTION OF THE LEFT AXILLARY ARTERY, THE PHYSICIAN TRIED TO PROGRESS THE DELIVERY SYSTEM OF THE EVOLUT PRO BUT WAS UNSUCCESSFUL. AFTER PUNCTURE OF THE LEFT FEMORAL ARTERY AND ACCOMMODATING THE GUIDEWIRE, THE SENTRANT 14F WAS SUCCESSFULLY INTRODUCED. THE INTRODUCER WAS REMOVED HOWEVER, THE DELIVERY SYSTEM OF THE HEART VALVE COULD NOT THEN BE INTRODUCED. IT WAS NOTED THE INSERTION OF THE INTRODUCER WAS TO TEST THE CALIBER OF THE ACCESS, BECAUSE IF THE SENTRANT WERE SUCCESSFULLY INTRODUCED, THE DELIVERY SYSTEM WITH THE PROSTHESIS WOULD PROBABLY ALSO PROGRESS. IT WAS NOTED THAT THE MINIMUM DIAMETER OF THE ACCESS FEMORAL ARTERY WAS 4.2 X 6.4MM. A LEFT ANGIOPLASTY WAS PERFORMED WITH A 7X40MM BALLOON. THE DELIVERY SYSTEM WAS THEN INSERTED BUT WOULD NOT ADVANCE THROUGH THE ARTERY DUE TO PATIENT'S ANATOMY. AN ATTEMPT WAS MADE TO INSERT THE 18F SENTRANT BUT IT WAS NOT SUCCESSFUL. THERE WAS EVIDENCE OF A DISSECTION IN THE ILIAC AND LEFT FEMORAL ARTERY. COVERED STENTS WERE SUCCESSFULLY THEN IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE DIFFICULTY TO ADVANCE WAS ANATOMY RE

  Patient problems: Vascular Dissection

  MAUDE report 14641487 ↗
• DeathApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS A CONDUIT FOR AN MEDTRONIC BIOPROSTHETIC VALVE. IT WAS NOTED THE ILIOFEMORAL ARTERY WAS CALCIFIED WITH A SMALL DIAMETER. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER DEPLOYMENT OF THE VALVE ANGIOGRAM IDENTIFIED A DISSECTION OF THE LEFT FEMORAL ARTERY WITH OCCLUSION OF THE PROFUNDA. 2 ADDITIONAL COVERED STENTS 7X5 MM AND 7X6 MM) WERE IMPLANTED. POST-OPERATIVE HEMOGLOBIN WAS NOTED AS 8.7. (13.1 PRE-OP). THE FOLLOWING DAY A CHEST X-RAY SHOWED ATELECTASIS AND/OR AN EFFUSION. IN ADDITION, THE FEMORAL ARTERY DISSECTION CAUSED SIGNIFICANT BLEEDING. TWO DAYS FOLLOWING THE VALVE IMPLANT, A COMPUTED TOMOGRAPHY REVEALED A LARGE ANTERIOR LEFT THIGH HEMATOMA. AN ECHOCARDIOGRAM NOTED AN ESTIMATED EJECTION FRACTION OF 60-65% WITH IMPAIRED RELAXATION PATTERN OF THE LEFT VENTRICULAR DIASTOLIC FILLING. DRY-HEAVING PRESENTED WHICH RESOLVED WITH MEDICATION. LOWER EXTREMITIES WERE AUSCULTATED VIA DOPPLER. ABDOMEN AND LEFT GROIN PAIN PRESENTED. SINUS TACHYCARDIA WAS OBSERVED AT A RATE OF 180 BEATS PER MINUTE BUT THIS QUICKLY RESOLVED. INTRAVENOUS THERAPY FLUIDS WERE ADMINISTERED. CHANGES IN PALLOR, WEAKNESS, AND URINE CONCENTRATION WERE REPORTED. THE PATIENT WAS TRANSFE

  Patient problems: Anemia; Cardiac Arrest; Cardiogenic Shock; Heart Failure/Congestive Heart Failure; Hematoma; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pallor; Tachycardia; Vascular Dissection

  MAUDE report 14207103 ↗
• DeathMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVI) PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED BY A CERTIFIED PHYSICIAN WITH EXTENSIVE EXPERIENCE. AFTER RELEASING THE VALVE, THE PATIENT BEGAN TO EXPERIENCE HYPOTENSION. THE ANESTHETIST TRIED TO REVERSE THE CONDITION WITH VASOACTIVE DRUGS, AT THIS TIME THE ECHOCARDIOGRAM PHYSICIAN REPORTED HAVING SEEN A PERICARDIAL EFFUSION, AFTER SEVERAL MANEUVERS TO REVERSE THE HYPOTENSION WITHOUT SUCCESS, THE OPERATING PHYSICIAN PLACED A CONTRAST PUMP REVEALING A MAJOR LEFT VENTRICULAR DISSECTION/PERFORATION AND PATIENT SUFFERED CARDIAC ARREST. CPR MANEUVERS WERE PERFORMED WITHOUT GREAT SUCCESS, CARDIAC SURGERY TEAM WAS CALLED BUT ALSO UNSUCCESSFUL. AFTER A FEW MINUTES, DEATH WAS CONFIRMED BY THE MEDICAL OPERATOR. PER PHYSICIAN, THE DISSECTION/PERFORATION WAS MOST LIKELY CAUSED BY THE NON-MEDTRONIC GUIDE. THE CAUSE OF DEATH CANNOT BE DETERMINED. THERE IS NO ALLEGATION OF DEFICIENCY AGAINST THE SENTRANT SHEATH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Myocardial Infarction; Perforation; Vascular Dissection

  MAUDE report 13888521 ↗
• MalfunctionSep 7, 2021Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS ATTEMPTED TO BE USED AS AN ACCESSORY DEVICE FOR A UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE SENTRANT SHEATH WAS REMOVED FROM THE RIGHT FEMORAL ARTERY AND PREPPED TO BE REINSERTED. ONCE THE EVOLUT DEVICE WAS DELIVERED AND REMOVED, IT WAS NOTED WHILE INTRODUCING THE SENTRANT SHEATH THAT THE HEMOSTATIC VALVE CAME DISLODGED FROM SHEATH. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432634 ↗
• MalfunctionFeb 22, 2021Material Deformation; Material Deformation

  A SENTRANT HYDRO SHEATH WAS ATTEMPTED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS STATED THAT DURING THE INDEX PROCEDURE, AS THE DEVICE WAS BEING PREPARED, THE VALVE BECOME DISCONNECTED FROM THE SHEATH HUB. ALTERNATIVELY, ANOTHER SENTRANT SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETE WITHOUT ANY ISSUE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358466 ↗