MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX; PORCINE SURGICAL MESH

Catalog Number	1161015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, one month post implant of the xenmatrix graft and bowel resection procedure the patient was diagnosed with a surgical site bacterial (staphylococcus aureus) infection and was treated with oral antibiotics.The clinician has assessed the patient¿s postoperative course of surgical site infection as possibly related to the study device and definitely related to the procedure.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Infection is a known inherent risk of surgery and is listed as a possible complication in the instructions-for-use (ifu) supplied with the device.Regarding infection, the warnings section of the ifu states, "if an infection develops, it should be treated aggressively." this mdr represent the ae of surgical site infection.An additional mdr has been submitted to represent the ae of hernia recurrence.Not returned - remains implanted.
Event or Problem Description
As reported per clinical study (b)(4): on (b)(6) 2016, the subject patient underwent multiple recurrent ventral midline open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in underlay fashion on the intra-peritoneal region using suture (maxon).Facia was completely closed with maxon suture in interrupted stitch technique and full skin closure was achieved with sutures.The patient was discharged on (b)(6) 2016.Concomitant procedure includes lysis of adhesion(s) and bowel resection.On (b)(6) 2017, the patient was diagnosed with surgical site infection and admitted to hospital on (b)(6) 2017 and ir drain placed.Intra-abdominal culture was performed, and the patient was diagnosed with (staphylococcus aureus) bacterial infection and treated with oral antibiotics.The patient was discharged to home on (b)(6) 2017.The ae is clinically assessed to be of moderate severity, possibly related to the study device, definitely related to procedure and recovered/resolved.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effect).

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 15501118
• Report Number: 1213643-2022-00633
• Device Sequence Number: 17457010
• Product Code: FTM
• UDI-Device Identifier: 00801741031380
• UDI-Public: (01)00801741031380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 02/28/2018
• Device Catalogue Number: 1161015
• Device Lot Number: HUAQ0052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG