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

Model Number SR-1040-CS

Device Problem Break (1069)

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

Event Date 11/09/2020

Event Type  malfunction  

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, the sent deployment system tip marker was found to be missing.Fluoroscopy was activated and the stent tip marker was on the guidewire at the end of the enroute sheath.A snare was inserted, and the tip was retrieved successfully with no reported patient harm or adverse consequence.A final angiogram was performed with no noted issues.

Manufacturer Narrative

The device investigation report was received and the following information was provided: the catheter tip separated was confirmed, however these damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the inner wire lumen shaft material was induced to a tensile force that exceeded the inner wire lumen shaft material yield strength prior to the separation.Procedural factors and/ or handling process may have contributed to the observed damages of the unit.The cause of the material separation observed on the inner wire lumen shaft could not be conclusively determined during the analysis.There is no evidence that suggests the reported failure could be related to the manufacturing process of the unit.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, the stent deployment system tip marker was found to be missing.Fluoroscopy was activated and the stent tip marker was on the guidewire at the end of the enroute sheath.A snare was inserted, and the tip was retrieved successfully with no reported patient harm or adverse consequence.A final angiogram was performed with no noted issues.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 10963523
• MDR Text Key: 220248268
• Report Number: 3014526664-2020-00123
• 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
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 11/13/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR