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

Catalog Number 1161935

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

As reported, post implant of the xenmatrix graft and bowel resection procedure, the patient was diagnosed with a surgical site infection and abscess.The clinician has assessed the patient¿s postoperative course of surgical site infection and abscess as possibly related to the study device and possibly 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.To date, this is the only reported complaint for this manufacturing lot of 16 units released for distribution in (b)(6) 2015.Infection is an known inherent risk of surgery and is listed as a possible complications in the instructions-for-use (ifu) supplied with the device.In regards to infection, the warnings section of the ifu states, "if an infection develops, it should be treated aggressively.".

Event Description

Alleged per clinical trial dvl-he-020: on (b)(6) 2015, the subject patient underwent first time recurrent midline incisional open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in underlay fashion intra-peritoneally, fixated using maxon sutures with interrupted stitch technique.The fascia closure was achieved using vicryl sutures with interrupted stitch technique and full skin closure was achieved using sutures.The patient was discharged on (b)(6) 2015.Concomitant procedure includes lysis of adhesion(s) and bowel resection.On (b)(6) 2015, the subject patient was diagnosed with surgical site infection and abscess.The patient underwent drainage culture test, resulted in positive for methicillin-resistant staphylococcus aureus.The patient was hospitalized and underwent drain insertion using interventional radiology, and treated with oral antibiotics.The patient was discharged to home on (b)(6) 2015 and the ae was resolved on (b)(6) 2016.On (b)(6) 2016, the subject patient was diagnosed with surgical site infection and abscess.The patient underwent drainage culture test, which resulted in no identification of pathogens.The patient was hospitalized on 09-feb-2016 and underwent drain insertion using interventional radiology, and treated with oral antibiotics.The patient was discharged to home on (b)(6) 2016 and the ae was resolved on (b)(6) 2016.The ae is clinically assessed to be of mild severity, possibly related to the study device and possibly related to the procedure and recovered/resolved.The reported adverse meets the definition of an sae (serious adverse event) and does not meet uade (unlisted adverse device event).

• Brand Name: XENMATRIX
• Type of Device: 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: 15294391
• MDR Text Key: 298602923
• Report Number: 1213643-2022-00594
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Catalogue Number: 1161935
• Device Lot Number: HUZG0240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 114 KG