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

Catalog Number	SR-090740-TCS
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a left transcarotid artery revascularization (tcar) procedure, upon deployment of the enroute transcarotid stent system (tss), the stent delivery system (sds) could not be removed as it was stuck on a stent strut due to hard calcium.The physician used interventional wires and balloon dilated the tight portion of the stent to remove the sds successfully, however, attempts to further dilate the stent were unsuccessful as the stent was compressed by calcium.The physician elected to explant the stent and converted the procedure to carotid endarterectomy (cea).There were no health consequences or impact to the patient.
Additional Manufacturer Narrative
The enroute transcarotid stent was investigated by silk road medical, however, the stent delivery system (sds) was not returned.Visual inspection of the stent did not reveal any physical abnormalities.The customer reported complaint could not be confirmed.Factors that could contribute to difficulties in removing the delivery system include lesion characteristics (e.G., calcification) and vessel anatomy (e.G., tortuosity), which may impact the implanted stent geometry.There is no evidence that manufacturing issues could contribute to the reported event.Hence, the root cause of the reported event could not be conclusively determined.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.If additional information is received, a supplemental report will be filed.

• Brand Name: ENROUTE TRANSCAROTID STENT SYSTEM
• Common Device Name: ENROUTE TSS
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 19923676
• Report Number: 3014526664-2024-00153
• Device Sequence Number: 7244846
• Product Code: NIM
• UDI-Device Identifier: 00811311021291
• UDI-Public: (01)00811311021291(17)260930(10)18252238
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: SR-090740-TCS
• Device Lot Number: 18252238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male