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

Model Number CMS15-10C

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported that device tearing occurred.A transcatheter aortic valve replacement procedure was taking place.A sentinel cerebral protection system (cps) was inserted via the radial artery.After successful deployment of the proximal filter in the innominate artery, the physician cannulated the left common carotid (lcc) artery twice prior to positioning the distal filter.After successful cannulation of the lcc, the distal filter was positioned, but could not be deployed.When the physician attempted to open the distal filter, strong resistance was felt, the distal filter slider would not move and failed to deploy.The proximal filter was fully recaptured with some resistance and the sentinel cps was removed from the patient's anatomy.Once outside the patient, the sentinel cps was flushed and distal filter opened without issue.Tearing of the proximal filter was observed.A new sentinel cps was utilized to successfully complete the procedure.There were no reported patient complications.

Manufacturer Narrative

H6: device code of difficult to remove added h3 device evaluated by manufacturer: the returned product consisted of a sentinel cerebral protection system.Visual analysis revealed the proximal filter unsheathed, the articulating distal sheath relaxed, the distal filter sheathed, the proximal filter torn, and the distal filter slider detached.A functional test was performed, and the distal filter could not be un-sheathed using the distal filter slider as the distal filter slider was detached.The proximal filter was able to be sheathed using the proximal filter slider without issue.The reported event of proximal filter tear was confirmed as a tear in the proximal filter was identified during visual inspection.This type of damage is consistent with excessive force during the deployment or operational factors such as technique/handling.

Event Description

It was reported that device tearing occurred.A transcatheter aortic valve replacement procedure was taking place.A sentinel cerebral protection system (cps) was inserted via the radial artery.After successful deployment of the proximal filter in the innominate artery, the physician cannulated the left common carotid (lcc) artery twice prior to positioning the distal filter.After successful cannulation of the lcc, the distal filter was positioned, however when the physician attempted to open the distal filter, strong resistance was felt, the distal filter slider would not move and the distal filter failed to deploy.The sentinel cps was removed from the patient's anatomy and resistance was noted while recapturing the proximal filter.Once outside the patient, the distal filter opened without issue.Tearing of the proximal filter was observed.A new sentinel cps was utilized to successfully complete the procedure.

• 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: 17352776
• MDR Text Key: 319489873
• Report Number: 2124215-2023-36075
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: 0030386312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female