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

Catalog Number	E10P16-J
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, we cannot conclusively determine the root cause of the reported incident.Additional details on the cause of the event were not provided in the article and further information was not available.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.
Event or Problem Description
During literature review the article indicated that one limb (2%) without postoperative wound complications required additional treatment due to acute bleeding during a study titled "clinical outcomes of common femoral thromboendarterectomy with bovine pericardium patch angioplasty".

• Brand Name: XENOSURE BIOLOGIC PATCH
• Common Device Name: BIOLOGIC PATCH
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 17698111
• Report Number: 1220948-2023-00145
• Device Sequence Number: 17800072
• Product Code: FTM
• UDI-Device Identifier: 00840663106349
• UDI-Public: (01)00840663106349
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: E10P16-J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown