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

Model Number CMS15-10C-US

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 04/13/2021

Event Type  malfunction  

Event Description

It was reported that the distal filter was removed unsheathed.Procedure summary: a sentinel cerebral protection system was advanced and deployed in the patient's type 1 aortic arch in preparation for a transcatheter aortic valve replacement (tavr) procedure.During retrieval of the distal filter, the distal filter hypotube fractured and the distal filter could not be re-sheathed.The sentinel cerebral protection system was then removed through the introducer sheath in tact with the proximal filter sheathed and the distal filter unsheathed.The tavr procedure was not completed due to perforation of the left ventricle unrelated to the sentinel cerebral protection system device.

Manufacturer Narrative

H3: device eval by manufacturer: the device was returned to boston scientific(bsc) and analyzed by a bsc quality engineer.Visual analysis of returned device revealed the device was returned with a guidewire loaded, the distal filter slider (#3) was bent/kinked, the proximal filter sheathed, the articulating distal sheath (ads) was relaxed and kinked, the distal filter was un-sheathed.Xray analysis of the returned device revealed inner member buckling.Functional testing of the returned device revealed the distal filter could not be sheathed using the distal filter slider (#3) due to inner member buckling.

Event Description

It was reported that the distal filter was removed unsheathed.Procedure summary: a sentinel cerebral protection system was advanced and deployed in the patient's type 1 aortic arch in preparation for a transcatheter aortic valve replacement (tavr) procedure.During retrieval of the distal filter, the distal filter hypotube fractured and the distal filter could not be re-sheathed.The sentinel cerebral protection system was then removed through the introducer sheath in tact with the proximal filter sheathed and the distal filter unsheathed.The tavr procedure was not completed due to perforation of the left ventricle unrelated to the sentinel cerebral protection system device.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11791175
• MDR Text Key: 249790544
• Report Number: 2134265-2021-05728
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• 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,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

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: 11/10/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026337936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/11/2021
• Patient Sequence Number: 1
• Patient Age: 79 YR