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

Model Number CMS15-10C

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem Transient Ischemic Attack (2109)

Event Date 11/10/2021

Event Type  Injury  

Event Description

It was reported that the device was stuck in the introducer sheath and transient ischemic attack (tia) occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed and the sentinel cps was advanced into position.The physician encountered difficulty in deploying one of the filters of the sentinel cps.While attempting to withdraw the sentinel cps, the sentinel became stuck in the introducer sheath causing buckling of the radial sheath.7cm of the sentinel cps remained outside the introducer sheath.The sentinel cps and introducer sheath were removed together from the patient.At an unspecified time, the patient experienced a transient ischemic attack (tia).The patient outcome is unknown.

Event Description

It was reported that the device was stuck in the introducer sheath and transient ischemic attack (tia) occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed and the sentinel cps was advanced into position.The physician encountered difficulty in deploying one of the filters of the sentinel cps.While attempting to withdraw the sentinel cps, the sentinel became stuck in the introducer sheath causing buckling of the radial sheath.7cm of the sentinel cps remained outside the introducer sheath.The sentinel cps and introducer sheath were removed together from the patient.At an unspecified time, the patient experienced a transient ischemic attack (tia).The patient outcome is unknown.It was further reported that the distal filter filter could not be deployed in the left common carotid artery due to tortuosity of the brachiocephalic artery and carotid angulation.The patient reportedly experienced the tia immediately post index procedure.A non-bsc valve was implanted.The patient was discharged home two days post index procedure.It was further reported that due to the anatomy of the patient, the distal curve could not be maneuvered into the left common carotid artery, thus the distal filter could not be placed in the left common carotid artery.There was no problem with the distal mechanism deployment.

Manufacturer Narrative

B5 describe event or problem - updated.

Event Description

It was reported that the device was stuck in the introducer sheath and transient ischemic attack (tia) occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed and the sentinel cps was advanced into position.The physician encountered difficulty in deploying one of the filters of the sentinel cps.While attempting to withdraw the sentinel cps, the sentinel became stuck in the introducer sheath causing buckling of the radial sheath.7cm of the sentinel cps remained outside the introducer sheath.The sentinel cps and introducer sheath were removed together from the patient.At an unspecified time, the patient experienced a transient ischemic attack (tia).The patient outcome is unknown.It was further reported that the distal filter filter could not be deployed in the left common carotid artery due to tortuosity of the brachiocephalic artery and carotid angulation.The patient reportedly experienced the tia immediately post index procedure.A non-bsc valve was implanted.The patient was discharged home two days post index procedure.

Event Description

It was reported that the device was stuck in the introducer sheath and transient ischemic attack (tia) occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed and the sentinel cps was advanced into position.The physician encountered difficulty in deploying one of the filters of the sentinel cps.While attempting to withdraw the sentinel cps, the sentinel became stuck in the introducer sheath causing buckling of the radial sheath.7cm of the sentinel cps remained outside the introducer sheath.The sentinel cps and introducer sheath were removed together from the patient.At an unspecified time, the patient experienced a transient ischemic attack (tia).The patient outcome is unknown.It was further reported that the distal filter filter could not be deployed in the left common carotid artery due to tortuosity of the brachiocephalic artery and carotid angulation.The patient reportedly experienced the tia immediately post index procedure.A non-bsc valve was implanted.The patient was discharged home two days post index procedure.It was further reported that due to the anatomy of the patient, the distal curve could not be maneuvered into the left common carotid artery, thus the distal filter could not be placed in the left common carotid artery.There was no problem with the distal mechanism deployment.

Manufacturer Narrative

Device evaluated by mfr.: the sentinel cerebral protection system (cps) was returned with a non-boston scientific (bsc) introducer sheath.Visual inspection revealed the non-bsc introducer sheath covered the proximal filter and therefore the proximal filter state could not be visually analyzed.The articulating distal sheath (ads) was relaxed and crushed.The articulating knob (#2) was loose.Due to the loose articulating knob (#2), the ads could not be flexed.Microscopic inspection of the sentinel cps identified screw drag marks on the articulating knob (#2).The distal filter was returned in a sheathed state and the distal filter slider (#3) was kinked.The distal filter was unable to be unsheathed due to the kink in the hypotube of the distal filter slider (#3).Following a flushing test, the proximal filter was able to be successfully unsheathed.The sentinel cps and non-bsc introducer sheath could be separated without issue.

• 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: 12965183
• MDR Text Key: 282101690
• Report Number: 2134265-2021-15610
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0027001329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other