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

Catalog Number	1161935
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hernia (2240)
Date of Event	08/18/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix graft, the patient was diagnosed with a hernia recurrence, and subsequent infection.Patient underwent additional surgery for removal of the graft.The clinician has assessed the patient¿s postoperative course as being 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 (b)(4) units released for distribution in may 2014.Hernia recurrence and infection are known inherent risks of the surgery and are included as possible complications in the adverse reactions section of 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.¿ not returned - mesh explanted.
Event or Problem Description
Per clinical trial dvl-he-020: on (b)(6) 2015, the patient underwent primary open hernia repair procedure for ventral hernia in llq location during which a xenmatrix surgical graft was trimmed and placed in underlay fashion in the intra-peritoneal region using sutures.Full skin closure was achieved using sutures with figure-8 technique.Concomitant procedure includes debridement of abdominal wall nonhealing wound.The patient was discharged on (b)(6) 2015.As reported, during a physical examination on (b)(6) 2015 the patient was diagnosed with ventral hernia recurrence in llq location.As reported on (b)(6) 2015, the patient was diagnosed with surgical site infection (ssi) and the culture test for the tissue was positive for staphylococcus aureus and treated with oral antibiotics/antimicrobials and resolved on (b)(6) 2016.It was reported that on (b)(6) 2016, the patient underwent reoperation to repair hernia recurrence and the graft was removed completely.Full skin closure was achieved using vicryl interrupted stitch.The patient was discharged on (b)(6) 2016.The ae (hernia recurrence and surgical site infection (ssi)) is clinically assessed to be moderate in severity, possibly related to the study device and possibly related to the index procedure and recovered/resolved.The reported ae (hernia recurrence) does meet the definition of serious (sae) and ae (surgical site infection (ssi)) does not meet the definition of serious (sae).

• 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: 15257799
• Report Number: 1213643-2022-00587
• Device Sequence Number: 5787519
• Product Code: FTM
• UDI-Device Identifier: 00801741031441
• UDI-Public: (01)00801741031441
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: 05/28/2016
• Device Catalogue Number: 1161935
• Device Lot Number: HUYD1102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 70 KG