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

Model Number	SR-0930-CS
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product associated with this complaint was returned to the manufacturer for analysis.The distal tip was not returned for analysis.Nevertheless, per microscopic analysis, scanning electron microscopy (sem) tests results showed that the separated area of the inner shaft of the unit presented evidence of elongations and cup and cone shape-like.Braid wires on the inner shaft presented evidence of plastic deformation, diameter reduction and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.The cause of the material separation observed on the inner shaft, the bent condition of the body/shaft of the catheter, and the partial deployment of the stent could not be conclusively determined during the analysis.The reported failure is not related to the manufacturing process of the unit.A review of 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 if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.
Event or Problem Description
It was reported that during a trans-carotid artery revascularization (tcar) procedure, the stent would not pass through the lesion.While pulling the stent back, the distal tip of the stent delivery system came off, and remained in the carotid artery.The physician made the decision to convert the procedure to a carotid endarterectomy (cea), and successfully removed the marker, and the carotid was fixed.There was no report of patient harm.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale CA 94089
• MDR Report Key: 10674067
• Report Number: 3014526664-2020-00091
• Device Sequence Number: 2942570
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)211130(10)17917092
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 11/30/2021
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 17917092
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR