MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. FLEXCEL CAROTID SHUNT (INLYING); CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	2020-05
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the device for evaluation since the device has been discarded by the hospital.Hence, we could not conclusively determine the root cause of the issue.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.We therefore believe this is an isolated incident.This is the only reported complaint of injury from using a flexcel device since we started marketing this product in 2007.After tipping process, each device is inspected by our manufacturing associate to ensure that the tips are rounded sufficiently and do not contain any flattened areas.Our ifu properly instructs users to select a proper size shunt since an inappropriate size shunt may cause damage to the vessel and may cause the plaque to dislodge from the vessel wall.
Event or Problem Description
During carotid endarterectomy, flexcel carotid shunt was used as a blood conduit to allow blood flow between the common and internal carotid artery.Surgeon experienced difficulty when positioning the shunt in the patient's artery as it was moving in the lumen.As a result, the tip of the shunt dissected a section of the internal carotid artery.Surgeon used a patch to repair the dissected section after extending the arteriotomy.

• Brand Name: FLEXCEL CAROTID SHUNT (INLYING)
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7603513
• Report Number: 1220948-2018-00039
• Device Sequence Number: 1623505
• Product Code: MJN
• UDI-Device Identifier: 00840663101344
• UDI-Public: 00840663101344
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/28/2024
• Device Catalogue Number: 2020-05
• Device Lot Number: FLX2293
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention