MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID STENT SYSTEM; ENROUTE TSS

Model Number SR-0840-CS

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

A report of this event and the malfunctioning device were provided to silk road medical as the manufacturer of the transcarotid stent system.A physical review of the device was conducted, which did not provide sufficient evidence to determine the cause of the failure.Based on testing conducted to date, we believe that the failure is related to a single operator that produced lots over a specific time period that did not meet specifications.The lots manufactured by this operator are currently undergoing corrective action as reports of other detachments were received.Based on this information, silk road medical initiated a voluntary product recall on january 13, 2021, which further expanded on january 24, 2021 and february 3, 2021.All information has been captured under (b)(4).

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, after stent deployment, the distal tip (nosecone) was detached from the stent deployment system (sds) during removal.The physician attempted the retrieval of the distal tip including the use of an abbott.014" 300cm command es wire as a buddy wire, and a 6x40 boston sterling balloon to post dilate.The physician was able to successfully retrieve the distal tip (nosecone) from the patient.The procedure was completed successfully with no reported patient harm or adverse consequences.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: magaly boardman ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087309002
• MDR Report Key: 11417875
• MDR Text Key: 239410633
• Report Number: 3014526664-2021-00030
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)211231(10)17924453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 17924453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3014526664-1/17/21-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR