MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH; MESH, SURGICAL

Catalog Number	E0.8P8
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)
Date of Event	10/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the patch for evaluation since the patch remains implanted in the patient.Hence, we could not conclusively determine the root cause of the defect.We were notified about this incident through fda ( report no.Mw5073649)on 12/19/2017 along with other three incidents ( report no.Mw5073648, mw5073661 and mw5073662) that occured at this same hospital.After following-up with the hospital, we learned that the culture report was (b)(6) growth.Significant purulent discharge was observed during the time of incision and drainage in the or.(b)(6) is known to be highly susceptible to destruction from our 0.2% glutaraldehyde storage solution.Further, our studies have shown that the hardest to sterilize/remove bacteria for our process are the bacillus and clostridium strain for which we have conducted extensive validation work to prove effectiveness of the sterilization process.Our review of the sterilization information for this lot found no abnormalities that would suggest a failure of the process.These facts indicate that these strains could not survive through our sterilization process or storage in the storage solution and indicates that the source of infection is some other cause.People can carry (b)(6) in their nose and on their skin without any symptoms.It is possible that the patient got infected with (b)(6) when the surgical wounds were in contact with someone or some surgical instruments during the surgery with exposed (b)(6).Patient is known to be diabetic, smoker and obese.The patients in these category is considered to be at risk for a surgical site infection.Facility conducted an extensive analysis on this series.They concluded that the infection was not related to the patch.However, the exact root cause was not determined.The review of lot history records did not reveal any discrepancies related to the complaint events either during the manufacturing or packaging processes for this lot and had passed all required tests.We have also not received any other complaints from other customers for devices from this lot.Please note that we have also submitted manufacturer report numbers: 1220948-2018-00002, 1220948-2018-00004 and 1220948-2018-00005 for the report no.Mw5073648, mw5073661 and mw5073662, respectively for the other three cases of the infection that occured at the same hospital.Infections can occur in any wound recognizing however that this is a very infrequent occurence for carotid artery surgery.The rate of occurrence for these kinds of incidents has remained very low (0.001%).The fact that the organisms differ in each of the specimens in each cases also indicates that the infection was from an external source or carrier.While the root cause(s) of this incident remains inconclusive, we do believe that it is highly unlikely that the xenosure patch contributed to the incident.
Event or Problem Description
Patient had a left carotid endarterectomy with patch angioplasty on (b)(6) 2017.Patient returned to the hospital on (b)(6) 2017 with swelling, redness and pain over the left neck.Infection had extended deep into the carotid sheath area.Deep incisional surgical site infection was observed.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7204768
• Report Number: 1220948-2018-00003
• Device Sequence Number: 19056502
• Product Code: FTM
• UDI-Device Identifier: 00840663106295
• UDI-Public: 00840663106295
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K040835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU2460
• 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: 12/19/2017
• Initial Report FDA Received Date: 01/18/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 89