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

Model Number CMS15-10C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/20/2021

Event Type  Injury  

Event Description

(b)(6) study.It was reported that bleeding occurred.Prior to the index procedure, heparin or other anticoagulant was given.The patient was on a prior regimen of aspirin and antiplatelet other than aspirin at the time of index procedure.The patient did not receive a loading dose of aspirin.After heparin had been given and during the start of the procedure, the activated clotting time (act) was noted to be 238 sec.An unknown manufacturer's introducer sheath was placed into right radial artery and the sentinel cerebral protection system (cps) was positioned.The proximal filter was deployed into brachiocephalic artery and distal filter was deployed into left common carotid artery.A 14f isleeve introducer was placed, and then the native aortic valve was treated with balloon valvuloplasty with a non-boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).The native aortic valve was treated with deployment of acurate neo2 valve.Post dilatation was not performed.There was correct positioning of a single prosthetic valve in the correct anatomical location.The sentinel cps was successfully retrieved without any complications.On the same day of the index procedure, the patient was noted with bleeding at the radial artery.Other action was taken in response to the event.The outcome of the event was considered as recovering/resolving.

Manufacturer Narrative

B5 describe event or problem - updated.B6 relevant tests/laboratory data - updated.

Event Description

The patient was enrolled in the protected tavr study on (b)(6) 2021 with patient identifier (b)(6).It was reported that bleeding occurred.Prior to the index procedure, heparin or other anticoagulant was given.The patient was on a prior regimen of aspirin and antiplatelet other than aspirin at the time of index procedure.The patient did not receive a loading dose of aspirin.After heparin had been given and during the start of the procedure, the activated clotting time (act) was noted to be 238 sec.An unknown manufacturer's introducer sheath was placed into right radial artery and the sentinel cerebral protection system (cps) was positioned.The proximal filter was deployed into brachiocephalic artery and distal filter was deployed into left common carotid artery.A 14f isleeve introducer was placed, and then the native aortic valve was treated with balloon valvuloplasty with a non-boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).The native aortic valve was treated with deployment of acurate neo2 valve.Post dilatation was not performed.There was correct positioning of a single prosthetic valve in the correct anatomical location.The sentinel cps was successfully retrieved without any complications.On the same day of the index procedure, the patient was noted with bleeding at the radial artery.Other action was taken in response to the event.The outcome of the event was considered as recovering/resolving.It was further reported the patient developed a 10 by 10cm subcutaneous hematoma.The bleeding was treated by applying a compression dressing.The patient was discharged after 8 days with prescriptions for clopidogrel and aspirin.

Event Description

The patient was enrolled in the protected tavr study on (b)(6) 2021 with patient identifier (b)(6).It was reported that bleeding occurred.Prior to the index procedure, heparin or other anticoagulant was given.The patient was on a prior regimen of aspirin and antiplatelet other than aspirin at the time of index procedure.The patient did not receive a loading dose of aspirin.After heparin had been given and during the start of the procedure, the activated clotting time (act) was noted to be 238 sec.An unknown manufacturer's introducer sheath was placed into right radial artery and the sentinel cerebral protection system (cps) was positioned.The proximal filter was deployed into brachiocephalic artery and distal filter was deployed into left common carotid artery.A 14f sleeve introducer was placed, and then the native aortic valve was treated with balloon valvuloplasty with a non-boston scientific (bsc) balloon catheter in accordance with the instructions for use (ifu).The native aortic valve was treated with deployment of accurate neo2 valve.Post dilatation was not performed.There was correct positioning of a single prosthetic valve in the correct anatomical location.The sentinel cps was successfully retrieved without any complications.On the same day of the index procedure, the patient was noted with bleeding at the radial artery.Other action was taken in response to the event.The outcome of the event was considered as recovering/resolving.It was further reported the patient developed a 10 by 10cm subcutaneous hematoma.The bleeding was treated by applying a compression dressing.The patient was discharged after 8 days with prescriptions for clopidogrel and aspirin.It was further reported the bleeding was caused by an inappropriate placement of the compression dressing on the puncture site and not the sentinel cps.A new compression dressing was applied.On the day after, the pulse was palpable and was not suspicious.The subject did not have pain.The subject was discharged from the hospital 8 days after the index procedure on aspirin and clopidogrel.The hematoma was expected to resolve.The event therefore has been withdrawn.

Manufacturer Narrative

B5 describe event or problem - updated.

• 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 Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13172801
• MDR Text Key: 283590618
• Report Number: 2134265-2022-00019
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Other
• Patient Age: 91 YR
• Patient Sex: Male