MAUDE Adverse Event Report: SILK ROAD MEDICAL INC. ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

The product associated with this complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could have led to the adverse event reported.There is no indication that a malfunction of the srm device occurred; the cause of the post-operative complication is unknown; therefore, the complaint will be reported out of abundance of caution.Complaints will continue to be reviewed and monitored for trends.A supplemental mdr will be submitted if additional information is received.

Event Description

It was reported that after the completion of a transcarotid artery revascularization (tcar) procedure, the patient woke up sluggish and was unable to move his right arm.Ultrasound and computed tomography (ct) showed a patent stent.Magnetic resonance imaging (mri) revealed multiple infarcts in the left middle cerebral artery (mca).Per the physician, the patient continued symptoms of aphasia and right sided weakness for more than 24 hours from the time of onset.No low blood pressures were noted.No surgical intervention was performed or planned.No p2y12 inhibitor testing has been performed.At this time, it is unknown if the reported failure is related to a silk road medical device failure or patient anatomical or procedural issues, hence, the event will be reported out of abundance of caution.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• 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: yvonne nguyen ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 15496875
• MDR Text Key: 300701854
• Report Number: 3014526664-2022-00157
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)241217(10)302353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 302353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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): Disability
• Patient Age: 69 YR
• Patient Sex: Male