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

Model Number SR-0930-CS

Device Problems Break (1069); Fracture (1260)

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

Event Date 09/14/2020

Event Type  malfunction  

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 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
• Type of Device: ENROUTE SDS
• 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: 10674067
• MDR Text Key: 213496901
• Report Number: 3014526664-2020-00091
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020492
• UDI-Public: (01)00811311020492(17)211130(10)17917092
• 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
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SR-0930-CS
• Device Catalogue Number: SR-0930-CS
• Device Lot Number: 17917092
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR