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

Model Number CMS15-10C

Device Problems Break (1069); Difficult to Remove (1528); Positioning Problem (3009)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

It was reported that a distal filter detachment occurred.Procedure summary: a sentinel cerebral protection system (cps) was selected for a transcatheter aortic valve replacement (tavr) procedure.The aortic anatomy was a type 1 arch.The sentinel cps was advanced into position over a.014 guidewire.An unknown manufacturer's valve was implanted to treat the native aortic annulus.Post valve implant, perivalvular leak was noted.A non-boston scientific (bsc) balloon catheter was advanced for post dilatation, and it was noted the sentinel cps was not in the intended position.The physician attempted to resheath the distal filter however the distal filter of the sentinel cps could not be resheathed.The proximal filter of the sentinel cps was able to be resheathed.The physician elected to retract the sentinel cps with the distal filter in an open position and the distal filter detached inside the patient.The detached distal filter was able to be retrieved from the patient with a snare.Patient status no patient complications were reported.The patient is currently stable with no neurological deficits noted.

Manufacturer Narrative

H3: device eval by manufacturer: visual and microscopic inspection of the returned sentinel cps revealed the state of the proximal filter could not be documented due to extensive damage in the unit.The distal filter & tri-layer were found detached from the unit and the distal filter detached from the hoop and the tri-layer stretched.The articulating distal sheath (ads) was kinked and damaged and detached from the sentinel cps with a portion of the proximal sheath.The skeleton was fractured.

Event Description

It was reported that a distal filter detachment occurred.Procedure summary: a sentinel cerebral protection system (cps) was selected for a transcatheter aortic valve replacement (tavr) procedure.The aortic anatomy was a type 1 arch.The sentinel cps was advanced into position over a.014 guidewire.An unknown manufacturer's valve was implanted to treat the native aortic annulus.Post valve implant, perivalvular leak was noted.A non-boston scientific (bsc) balloon catheter was advanced for post dilatation, and it was noted the sentinel cps was not in the intended position.The physician attempted to resheath the distal filter however the distal filter of the sentinel cps could not be resheathed.The proximal filter of the sentinel cps was able to be resheathed.The physician elected to retract the sentinel cps with the distal filter in an open position and the distal filter detached inside the patient.The detached distal filter was able to be retrieved from the patient with a snare.Patient status no patient complications were reported.The patient is currently stable with no neurological deficits noted.It was further reported that as the non-bsc balloon catheter was advanced, the distal filter of the sentinel cps was dislocated from the left common carotid artery to the aortic arch.After the distal filter was not able to be resheathed, the physician attempted to reflex the articulating distal sheath and was unsuccessful.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15715719
• MDR Text Key: 306639881
• Report Number: 2124215-2022-44740
• 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
• Report Date: 01/10/2023

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: 03/29/2023
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0027055282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1