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

Model Number SR-0840-CS

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint reported by the customer as "stent delivery system (sds)-ses - withdrawal difficulty - snagged/caught on stent" was not confirmed since insertion/withdrawal test couldn't be performed on the unit due to the separation observed on the inner shaft.The complaint reported by the customer as "catheter tip - separated - in patient" was confirmed since a material separation was observed on the inner shaft near to the distal tip.Nevertheless, per microscopic analysis, scanning electron microscopy (sem) results showed that the separated area of the inner shaft of the unit presented evidence of elongations.Braid wires on the inner shaft presented evidence of plastic deformation, diameter reduction, tension marks and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the inner shaft material was induced to a tensile force that exceeded the inner shaft material yield strength prior to the separation.Per the observed damage, it could be suggested that procedural factors and/ or handling process may have contributed to the observed damaged condition of the unit.Nevertheless, the cause of the material separation observed on the inner shaft could not be conclusively determined during the analysis.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.

Event Description

It was reported that during a transcarotid artery revascularization (tcar) procedure, the sds distal tip became entangled in the stent when the physician attempted to remove it.The physician used various methods to free the device and was unsuccessful.Re-sheathing the tip, twisting, advancing then retracting, etc.The distal 5cm of the catheter became disconnected from the sds.The physician used a glidewire next to the existing interventional wire in place to deliver a 5x30 balloon.The balloon was inflated then removed and a 5mm snare was used to capture the fragment.It was successfully removed.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyvale, ca
• Manufacturer (Section G): SILK ROAD MEDICAL INC.; 1213 innsbruck drive; sunnyale, ca
• Manufacturer Contact: magaly boardman ; 1213 innsbruck drive; sunnyvale, ca ; 7209002
• MDR Report Key: 10484990
• MDR Text Key: 231226244
• Report Number: 3014526664-2020-00078
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 0081131020478
• UDI-Public: (01)0081131020478(17)210331(10)17859706
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 17859706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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 Age: 75 YR