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

Model Number SR-1040-CS

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint has been returned, however the investigation is underway.A preliminary review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.A follow-up mdr will be submitted once additional information is made available.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, after stent deployment, the distal tip (nosecone) was found still inside the stent.The physician used a 4mm ensnare to remove marker which was still attached to the stent nose cone.The procedure was completed sucessfully with no reported patient harm.

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 capa(b)(4).

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, after stent deployment, the distal tip (nosecone) was found still inside the stent.The physician used a 4mm ensnare to remove marker which was still attached to the stent nose cone.The procedure was completed sucessfully with no reported patient harm.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 11270626
• MDR Text Key: 240053771
• Report Number: 3014526664-2021-00014
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020539
• UDI-Public: (01)00811311020539(17)220131(10)17931107
• Combination Product (y/n): N
• PMA/PMN Number: P140026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SR-1040-CS
• Device Catalogue Number: SR-1040-CS
• Device Lot Number: 17931107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3014526664-1/17/21-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR