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

Model Number SR-1030-CS

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

The products associated with this reported event were not returned to the manufacturer for analysis.Nevertheless, the customer provided photographic evidence and a review of the manufacturing records was performed.No issues were identified that could have led to the adverse event reported.Complaints will continue to be reviewed and monitored for trends.A follow-up mdr will be submitted if additional information is obtained.Silk road medical will continue to monitor for occurrences of similar events.On october 23, 2020, a user facility medwatch was received from the hospital directly.A secondary mdr is submitted under 3500a form # 3014526664-2020-00104 since two stents were initially placed on this patient and at this time it is unknown which device may have caused or contributed to the reported event.

Event Description

It was reported that after the completion of a transcarotid artery revascularization (tcar) procedure, the patient was complaining of a headache.A computerized tomography scan (ct scan) was performed and revealed the patient experienced filling defect in the ipsilateral cavernous internal carotid artery consistent with a foreign body being present.The patient was transferred to a different hospital where neurosurgery attempted to remove the foreign body via transfemoral approach.On attempts to remove the object, the object inadvertently embolized to the profunda femorous artery, where further attempts to retrieve it were not made.In this position, the foreign body is unlikely to contribute to clinical sequelae.The patient was reported to be well, and without neurological deficit.

• 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: 10831669
• MDR Text Key: 216010613
• Report Number: 3014526664-2020-00105
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 000811311020492
• UDI-Public: (01)000811311020492(17)220131(10)17929776
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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-1030-CS
• Device Catalogue Number: SR-1030-CS
• Device Lot Number: 17929776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 143