MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC. ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

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

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for evaluation.A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) year old female patient underwent a left transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.A dissection plain was discovered in the left common carotid artery (lcca) post procedure.Flow reversal was established.The physician attempted several maneuvers to engage the internal carotid artery (ica) on flow reversal, with a 0.014 wire, including removing the system and resticking.However, these attempts were unsuccessful.Ultimately the physician aborted the tcar procedure and performed a transfemoral carotid artery stenting (tfcas) procedure.The patient awoke from the procedure with no issues and was discharged home the following day.No additional details were provided.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale 94089
• Manufacturer Contact: 1213 innsbruck dr.; sunnyvale, CA 94089
• MDR Report Key: 9050920
• MDR Text Key: 160062744
• Report Number: 3014526664-2019-00070
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)220206(10)300430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2022
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/13/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR