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

Model Number CMS15-10C

Device Problems Mechanical Problem (1384); Difficult to Remove (1528)

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

Event Date 01/19/2021

Event Type  malfunction  

Event Description

It was reported that the distal and proximal filters of the sentinel cerebral protection system failed to re-sheath.Procedure summary: a sentinel cerebral protection system was used in a transcatheter aortic valve replacement (tavr) procedure.The patient anatomy consisted of mild calcium, stenosis and tortuosity.The sentinel cerebral protection system was placed successfully.Both the proximal and distal filters were deployed without any issues.An acurate valve was successfully implanted.While attempting to remove the sentinel cerebral protection system, the physician encountered difficulty articulating the sentinel cerebral protection system.The sentinel device was removed from the patient with both filters in a deployed state.As a unit with the 6fr non-boston scientific sheath.The patient has fully recovered with no post procedural complications.

Manufacturer Narrative

B5 describe event or problem - updated.

Event Description

It was reported that the distal and proximal filters of the sentinel cerebral protection system failed to re-sheath.Procedure summary: a sentinel cerebral protection system was used in a transcatheter aortic valve replacement (tavr) procedure.The patient anatomy consisted of mild calcium, stenosis and tortuosity.The sentinel cerebral protection system was placed successfully.Both the proximal and distal filters were deployed without any issues.An acurate valve was successfully implanted.While attempting to remove the sentinel cerebral protection system, the physician encountered difficulty articulating the sentinel cerebral protection system.The sentinel device was removed from the patient with both filters in a deployed state.As a unit with the 6fr non-boston scientific sheath.The patient has fully recovered with no post procedural complications.It was further reported that the physician initially attempted to resheath the distal filter by retracting the distal filter slider; however, the distal filter did not respond to the distal filter slider.The distal filter was left unsheathed while attempting to articulate the sentinel embolic protection system.The physician attempted to resheath the proximal filter by retracting the proximal filter slider; however, the proximal filter did not respond to the proximal filter slider.

Event Description

It was reported that the distal and proximal filters of the sentinel cerebral protection system failed to re-sheath.Procedure summary: a sentinel cerebral protection system was used in a transcatheter aortic valve replacement (tavr) procedure.The patient anatomy consisted of mild calcium, stenosis and tortuosity.The sentinel cerebral protection system was placed successfully.Both the proximal and distal filters were deployed without any issues.An acurate valve was successfully implanted.While attempting to remove the sentinel cerebral protection system, the physician encountered difficulty articulating the sentinel cerebral protection system.The sentinel device was removed from the patient with both filters in a deployed state.As a unit with the 6fr non-boston scientific sheath.The patient has fully recovered with no post procedural complications.It was further reported that the physician initially attempted to resheath the distal filter by retracting the distal filter slider; however, the distal filter did not respond to the distal filter slider.The distal filter was left unsheathed while attempting to articulate the sentinel embolic protection system.The physician attempted to resheath the proximal filter by retracting the proximal filter slider; however, the proximal filter did not respond to the proximal filter slider.

Manufacturer Narrative

H3 device evaluated by mfr: the sentinel cerebral protection system (cps) was returned for device analysis.Overall visual inspection did not identify failures or evidence that could be lost due to the decontamination process.The sentinel cps was returned with a non-boston scientific (bsc) introducer sheath.The non-bsc introducer sheath was buckling and accordioned with blood residue observed within the clear tubing.The sentinel cps was returned with the proximal filter partially un-sheathed, and the distal filter un-sheathed.The sentinel cps could not be removed from the non-bsc introducer sheath due a detachment of the articulating distal sheath (ads) from the skeleton and the buckling/accordioned condition of the introducer sheath.X-ray inspection of the sentinel cps revealed the pull wire tubing was kinked and the pull wire was broken within the rear handle shells.There was inner member buckling under the rear handle shells.The ads did not respond when turning the articulating knob (#2) due to the breakage of the pull wire.The distal filter could not be sheathed using the distal filter slider (knob#3) confirming the reported complaint.The proximal filter was able to be sheathed and un-sheathed.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11275913
• MDR Text Key: 230243904
• Report Number: 2134265-2021-01186
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0025960271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 03/12/2021
• Supplement Dates FDA Received: 02/22/2021; 03/26/2021
• Patient Sequence Number: 1
• Patient Age: 79 YR