MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Event Description

This event is reportable based on returned device analysis completed on 02 november 2023.It was reported distal filter slider detachment occurred.Procedure summary during a transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a severely tortuous right transfemoral approach.The right common iliac artery was noted to be very tortuous below the aortic bifurcation with two severe bends.The moderately calcified native aortic annulus measured 25.7mm in diameter.A sentinel cerebral protection system (cps) was successfully placed with the proximal filter deployed in the innominate artery and distal filters deployed in the left common carotid artery.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 24mm non-boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).A size large acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.During advancement of the acurate neo2 tf ds into the 14f isleeve introducer sheath, resistance was experienced and it was not possible to advance the acurate neo2 tf ds past the second severe bend of the right common iliac artery and through the length of the 14f isleeve introducer sheath.The acurate neo2 tf ds with loaded acurate neo2 valve was removed from the patient.Upon removal, it was noted the acurate neo2 tf ds outer member was damaged and the acurate neo2 valve was compressed and the stabilization arches were tangled.The 14f isleeve introducer sheath was removed separately from the patient.Vascular access was obtained via a left transfemoral approach and the procedure was successfully completed using a new 14f isleeve introducer sheath, safari2 guidewire, acurate neo2 tf ds, and size large acurate neo2 valve.During recapture of the distal filter of the sentinel cps the distal filter slider detached from the handle.The proximal and distal filters of the sentinel cps were fully recaptured prior to removal of the device from the patient.Patient status the patient fully recovered and was discharged.However, returned device analysis identified a tear in the proximal filter of the sentinel cps.

Manufacturer Narrative

Device technical analysis the returned device consisted of a sentinel cps.Visual analysis of the returned device revealed the proximal and distal filters were unsheathed, the proximal filter was torn, the articulating distal sheath (ads) was relaxed, the distal filter slider was detached, and the proximal sheath was detached.A flow test could not be performed due to the detached distal filter slider.During functional testing, the proximal filter was unable to be sheathed due to a kink and break in the inner member of the sentinel cps.The distal filter was unable to be recaptured due to the detachment of the distal filter slider.Product analysis confirmed the reported event of distal filter slider separation during procedure.Product analysis also identified a tear in the proximal filter, the proximal sheath was kinked and broken, and the sentinel cps inner member was broken.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18618921
• MDR Text Key: 334787569
• Report Number: 2124215-2024-05145
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0030902853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female