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

Model Number SR-0840-CS

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

Patient Problems Brain Injury (2219); Patient Problem/Medical Problem (2688)

Event Date 02/01/2018

Event Type  Injury  

Event Description

Enroute neuroprotection system was successfully placed without incident, and full reversal of flow was established/confirmed.Patient had flow limiting lesion in lica, and dr.Cunningham used a 3x40 balloon to pre-dil, placed an 8x40 enroute stent, and used a 5x40 post-dil balloon.Pressures remained above 160 systolic throughout intervention with the exception of after stenting.Once 8x40 stent was placed and removed, pressures dropped to 128 systolic.More atropine was given, and after systolic pressure came up to 172 systolic, the 5x40 balloon was introduced and used.After removing all catheters and wires, and before unclamping, several angiograms/angles were taken of the intracranial arteries, and they appeared to be fully patent and intact.This step added 2+min of reverse flow time post intervention.Being happy with the results, physician unclamped, normal blood flow returned, and patient was fully responsive with both verbal and motor function.Patient was removed from the or room, and taken to post-op holding.Once there, the patient stopped being responsive and was unable to purposefully move appendages.Patient was taken back into the or suite, cut-down was reopened, and an angiogram was performed through a micro-puncture kit.Both bifurcation and intracranial appeared patent with no visible defect.Physician took patient back to post-op and then to icu, where patient's pressure would remain stable, and would be under constant surveillance for the next 24 hours.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Type of Device: ENROUTE SDS
• Manufacturer (Section D): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer (Section G): SILK ROAD MEDICAL; 735 north pastoria avenue; sunnyvale CA 94085
• Manufacturer Contact: branka spremo ; 735 north pastoria avenu; sunnyvale, CA 94085 ; 4087209002
• MDR Report Key: 7325913
• MDR Text Key: 101954310
• Report Number: 3007215228-2018-00007
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00811311020478
• UDI-Public: (01)00811311020478(17)180531(10)200651
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: SR-0840-CS
• Device Catalogue Number: SR-0840-CS
• Device Lot Number: 200651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2016
• 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: 70 YR