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

Model Number CMS15-10C

Device Problems Positioning Failure (1158); Failure to Advance (2524); Positioning Problem (3009)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that the proximal filter moved out of position in an open state.Procedure summary: a sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implant (tavi) procedure.The vascular anatomy was a non calcified, non tortuous and non stenosed type 1 arch.Radial access was gained.The sentinel cps was initially advanced over a.014 non-boston scientific (bsc) guide wire; however, the sentinel cps was not able to advance due to the small radial artery.Brachial access was then obtained and the sentinel cps was able to be advanced into position.The proximal filter of the sentinel cps was deployed; however, the proximal filter fell out of position in an open state.The proximal filter of the sentinel cps was resheathed.The physician attempted to redeploy the proximal filter of the sentinel cps; however the proximal filter of the sentinel cps could not be redeployed.The sentinel cps was removed from the patient and exchanged for another sentinel cps.The new sentinel cps was successfully used to complete the procedure.Patient status.No patient harm occurred.

Manufacturer Narrative

B5: describe event or problem: updated.

Event Description

It was reported that the proximal filter moved out of position in an open state.Procedure summary: a sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implant (tavi) procedure.The vascular anatomy was a non calcified, non tortuous and non stenosed type 1 arch.Radial access was gained.The sentinel cps was initially advanced over a.014 non-boston scientific (bsc) guide wire; however, the sentinel cps was not able to advance due to the small radial artery.Brachial access was then obtained and the sentinel cps was able to be advanced into position.The proximal filter of the sentinel cps was deployed; however, the proximal filter fell out of position in an open state.The proximal filter of the sentinel cps was resheathed.The physician attempted to redeploy the proximal filter of the sentinel cps; however the proximal filter of the sentinel cps could not be redeployed.The sentinel cps was removed from the patient and exchanged for another sentinel cps.The new sentinel cps was successfully used to complete the procedure.Patient status no patient harm occurred.It was further reported that the proximal filter of the sentinel cps fell out of the brachiocephalic artery and slid into the aorta.The second sentinel cps used was advanced via brachial access using a 6fr non-bsc introducer sheath.

Event Description

It was reported that the proximal filter moved out of position in an open state.Procedure summary: a sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implant (tavi) procedure.The vascular anatomy was a non calcified, non tortuous and non stenosed type 1 arch.Radial access was gained.The sentinel cps was initially advanced over a.014 non-boston scientific (bsc) guide wire; however, the sentinel cps was not able to advance due to the small radial artery.Brachial access was then obtained and the sentinel cps was able to be advanced into position.The proximal filter of the sentinel cps was deployed; however, the proximal filter fell out of position in an open state.The proximal filter of the sentinel cps was resheathed.The physician attempted to redeploy the proximal filter of the sentinel cps; however the proximal filter of the sentinel cps could not be redeployed.The sentinel cps was removed from the patient and exchanged for another sentinel cps.The new sentinel cps was successfully used to complete the procedure.Patient status: no patient harm occurred.It was further reported that the proximal filter of the sentinel cps fell out of the brachiocephalic artery and slid into the aorta.The second sentinel cps used was advanced via brachial access using a 6fr non-bsc introducer sheath.

Manufacturer Narrative

H3: device eval by manufacturer: analysis of the returned product by visual inspection revealed the sentinel cerebral protection system (cps) was returned with the proximal filter sheathed, the articulating distal sheath (ads) relaxed, and the distal filter unsheathed.The distal part of the outer shaft/sheath was dissected.After dissection, reinforcing braid wear was found on the internal part of the outer shaft/sheath (inner shaft/sheath).Before flushing, the proximal filter was unable to be un-sheathed using the proximal filter slider (#) 1.After flushing, the proximal filter was able to be un-sheathed using the proximal filter slider (#) 1.

• 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: 12804977
• MDR Text Key: 280960902
• Report Number: 2134265-2021-14267
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• 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: 0027001320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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