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

Model Number CMS15-10C

Device Problem Positioning Problem (3009)

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

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The patient was enrolled in the (b)(6) clinical study (sentinel group) on (b)(6) 2021 with patient identifier (b)(6).It was reported that the distal filter dislodgment occurred.The patient was enrolled into the (b)(6) clinical study (b)(6) and the index procedure was performed on the same day.Prior to the index procedure, heparin or another anticoagulant was given.The patient was not on a prior regimen of aspirin or antiplatelet other than aspirin at the time of the index procedure.The patient did not receive a loading dose of aspirin.After heparin was given and prior to sentinel cerebral protection device insertion, the activated clotting time (act) was 337 seconds.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery and distal filter into left common carotid artery.An arterial sheath was placed, and the native aortic valve was treated with balloon valvuloplasty and subsequent deployment of a non-boston scientific (bsc) valve.Post dilatation was performed on the non-bsc valve.During the index procedure, the distal filter of the sentinel cps dislodged from the left common carotid artery prior to completion of the procedure while in the open state.The sentinel cps was successfully retrieved after the procedure without any complications.There were no patient complications reported.Three days post index procedure, the patient was discharged home on 60mg of another anticoagulant.

Manufacturer Narrative

B5: describe event or problem- updated.B6: relevant test/laboratory data - updated.

Event Description

The patient was enrolled in the protected tavr clinical study (sentinel group) on (b)(6)2021 with patient identifier (b)(6).It was reported that the distal filter dislodgment occurred.The patient was enrolled into the protected tavr clinical study (sentinel group) and the index procedure was performed on the same day.Prior to the index procedure, heparin or another anticoagulant was given.The patient was not on a prior regimen of aspirin or antiplatelet other than aspirin at the time of the index procedure.The patient did not receive a loading dose of aspirin.After heparin was given and prior to sentinel cerebral protection device insertion, the activated clotting time (act) was 337 seconds.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery and distal filter into left common carotid artery.An arterial sheath was placed, and the native aortic valve was treated with balloon valvuloplasty and subsequent deployment of a non-boston scientific (bsc) valve.Post dilatation was performed on the non-bsc valve.During the index procedure, the distal filter of the sentinel cps dislodged from the left common carotid artery prior to completion of the procedure while in the open state.The sentinel cps was successfully retrieved after the procedure without any complications.There were no patient complications reported.Three days post index procedure, the patient was discharged home on 60mg of another anticoagulant.It was further reported that the distal filter dislodgement occurred after the implant of a non-bsc valve and likely occurred as a result of an interaction between the non-bsc valve delivery system and sentinel cps during removal of the non-bsc valve delivery system.No attempts were made to reposition the distal filter of the sentinel cps.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 3636 n. laughlin blvd, suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12804840
• MDR Text Key: 281012801
• Report Number: 2134265-2021-14072
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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: 04/12/2023
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0027125940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female