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

Model Number CMS15-10C-US

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

(b)(6) study.It was reported that the distal filter moved out of position in an open state.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or antiplatelet medication.After heparin was given and prior to the sentinel cerebral protection system was inserted, the activated clotting time was 96 sec.An introducer was placed into the right radial artery and the sentinel cerebral protection system was then advanced.The proximal filter was placed in the brachiocephalic artery and the distal filter was placed in the left common carotid artery.The native aortic valve was then treated with balloon valvuloplasty and subsequent deployment of a non-boston scientific valve.Post dilation was performed.At the end of the procedure, it was noted that the distal filter of the sentinel cerebral protection system had moved out of position in an open state.No attempt was made to reposition the sentinel cerebral protection system.The sentinel cerebral protection system could not be removed through the radial sheath as the radial sheath became deformed, so the radial sheath was removed followed by the removal of the sentinel cerebral protection system.There were no patient consequences.

Event Description

Protected tavr study.It was reported that the distal filter moved out of position in an open state.The patient was enrolled into the protected tavr study and the index procedure was performed on the same day.Prior to index procedure, heparin or other anticoagulant was given and the patient was not on a prior regimen of aspirin or antiplatelet medication.After heparin was given and prior to the sentinel cerebral protection system was inserted, the activated clotting time was 96 sec.An introducer was placed into the right radial artery and the sentinel cerebral protection system was then advanced.The proximal filter was placed in the brachiocephalic artery and the distal filter was placed in the left common carotid artery.The native aortic valve was then treated with balloon valvuloplasty and subsequent deployment of a non-boston scientific valve.Post dilation was performed.At the end of the procedure, it was noted that the distal filter of the sentinel cerebral protection system had moved out of position in an open state.No attempt was made to reposition the sentinel cerebral protection system.The sentinel cerebral protection system could not be removed through the radial sheath as the radial sheath became deformed, so the radial sheath was removed followed by the removal of the sentinel cerebral protection system.There were no patient consequences.It was further reported that the proximal filter dislodged during valve insertion, prior to the completion of the procedure.

Manufacturer Narrative

B5 describe event or problem - updated.

• 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: 11036351
• MDR Text Key: 222402930
• Report Number: 2134265-2020-18019
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026015935
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR