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

Model Number	SR-0930-CS
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional 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 detachment were received.Based on this information, silk road medical initiated a voluntary product recall on (b)(6) 2021, which further expanded on (b)(6) 2021 and (b)(6) 2021.All information has been captured under capa- (b)(4).
Event or Problem 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).A snare was used to successfully retrieve the tip from the patient.The procedure was completed successfully with no reported patient harm or adverse consequences.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 11355313
• Report Number: 3014526664-2021-00021
• Device Sequence Number: 14480159
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)220131(10)17933389
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 17933389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014526664-1/17/21-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR