MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGIC PATCH; INTRACARDIAC PATCH OR PLEDGET

Model Number	e1P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the patch for investigation.The patch was initially implanted on the patient on (b)(6) 2020.The patch remained implanted in the patient for more than one and half years before the onset of the symptoms.We have requested the surgeon to provide us with additional information including the strain of bacteria that was identified in the culture and if the patient has recently undergone any other surgeries.However, we have not yet received any response.Our validation studies have shown that the hardest to sterilize/remove bacteria for our process are the bacillus and clostridium strains for which we have conducted extensive validation work to prove the effectiveness of the sterilization process.At this time, we could not confirm the source of infection.We have manufactured a total of 488 xenosure biologic patches in this lot number.We have sold all of the patches.We have not received any other complaints related to a similar incident.
Event or Problem Description
Patient had a carotid endarterectomy with patch done on (b)(6) 2020.She presented in (b)(6) 2022 with an infection that required surgical intervention.Culture of explanted patch showed infection.

• Brand Name: XENOSURE BIOLOGIC PATCH
• Common Device Name: INTRACARDIAC PATCH OR PLEDGET
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7342231640
• MDR Report Key: 14197397
• Report Number: 1220948-2022-00033
• Device Sequence Number: 4556214
• Product Code: PSQ
• UDI-Device Identifier: 00840663106288
• UDI-Public: 00840663106288
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K190882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Expiration Date: 05/28/2024
• Device Model Number: e1P6
• Device Catalogue Number: EIP6
• Device Lot Number: XBU3656
• 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: 03/26/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown