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 Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

The product in complaint was not returned to the manufacturer for evaluation.A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Complaints will continue to be monitored for any trends.

Event Description

It was reported that a (b)(6) male patient with a contralateral occlusion, underwent the transcarotid artery revascularization (tcar) procedure on (b)(6) 2019.Venous, micro puncture and arterial sheath access were all gained and in accordance with the ifu.Unprotected flow was also reported to be smooth.According to the physician, while attempting to engage the lesion, the 0.14 enroute wire was not performing.After attempting a few times to advance the wire past the lesion, it was observed that the wire was backed out.An angiogram was taken, which confirmed the presence of a dissection.The physician believes that the wire was possibly in a dissection plane.In an attempt to get out of the dissection plane, the physician backed the sheath out.However, the wire was still not advancing as expected.The physician removed the wire and the balloon, disconnected the nps, and removed the sheath to re-access the proximal common carotid artery (cca).A second attempt to access with the micropuncture and enroute arterial sheath was successful.However, two views showed a clearer picture of the dissection off a branch off the external carotid artery (eca).After several unsuccessful attempts to wire the cca and ica, the surgeon made the decision to abort the case.A hematoma was present on the patient's right neck jaw line due to the dissection.A drain was placed at the exposure site.Patient was neuro intact at the end of the procedure and according to the surgeon the patient was doing well post op.No additional details were provided.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: 1213 innsbruck dr.; sunnyvale, CA 94089
• MDR Report Key: 9137751
• MDR Text Key: 165549278
• Report Number: 3014526664-2019-00073
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)210103(10)300346
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2019

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 Expiration Date: 01/03/2021
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 68 YR