MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. BOVINE XENOSURE BIOLOGIC PATCH; CAROTID PATCH

Lot Number XBU2659

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Bacterial Infection (1735); Swelling (2091); Chills (2191)

Event Date 11/13/2017

Event Type  Injury  

Event Description

Patient admitted (b)(6) 2017 with fever, chills, and increased swelling of right side of neck.Patient had a right endarterectomy with patch angioplasty on (b)(6) 2017 at (b)(6).Patient taken to the operating room on (b)(6) 2017 for i and d for surgical site.Neck abscess fluid has thus far revealed gram positive cocci.Patient qualities for an ssi.Streptococcus agalactiae.Bovine xenosure biologic patch lot xbu2659 exp date 04/28/2023 (noted on scanned implant record).01/28/2023 (noted on surginet output record).Prepared with 0.9 percent nss lot g130310 exp aug 2020.

• Brand Name: BOVINE XENOSURE BIOLOGIC PATCH
• Type of Device: CAROTID PATCH
• Manufacturer (Section D): LEMAITRE VASCULAR, INC. ; 63 second ave. ; burlington MA 01803
• MDR Report Key: 7074824
• MDR Text Key: 93625634
• Report Number: MW5073662
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Lot Number: XBU2659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 65