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

Model Number CMS15-10C

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event - exact date unknown.Occurred between (b)(6) 2018 to (b)(6) 2018.

Event Description

Voss s, ernst a, erlebach m, et al.Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: a prospective pilot study.J card surg.2021;36:1241-1248.Https://doi.Org/10.1111/jocs.15355 it was reported via above literature article that filter dislodgement occurred.Literature study methods: in a prospective pilot study between may 2018 and august 2018, 20 patients, who were part of the ongoing single-center, randomized protect tavi trial, underwent a transfemoral transcatheter aortic valve replacement (tavr) with and without cerebral embolic protection using the sentinel cerebral protection system.All patients received conscious sedation and cerebral oxygen saturation (rso2) was continuously measured with near-infrared spectroscopy (nirs).The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rso2 below an individualized desaturation threshold by time.In addition, rso2 values at the time of sentinel cerebral protection system insertion, filter positioning, and device retraction were analyzed.Literature study results: there was no significant difference in cumulative cerebral desaturation in patients with sentinel cerebral protection system and without.A total of 6 patients (33.3%) experienced a perioperative decrease in rso2 below the individualized desaturation threshold.Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1).No desaturation events occurred during sentinel cerebral protection system insertion, filter positioning, or retraction.Literature study conclusions: the pilot study revealed no difference in cumulative perioperative cerebral desaturation between tavr with and without sentinel cerebral protection system.Catheter and filter based manipulations in the brain-supplying arteries for sentinel cerebral protection system application were not associated with a decrease of cerebral perfusion and oxygenation.Event summary: the patient met all treatment requirements for implantation of the sentinel cerebral protection system.There were no severe calcifications of the filter target vessels.Filter implantation was uneventful.An initially correct deployed filter then dislocated and additional attempts to reposition the filter failed.Therefore, the patient was not included in the study cohort.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12028405
• MDR Text Key: 257226948
• Report Number: 2134265-2021-07873
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1