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	Hernia (2240)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
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 recurrent ventral midline hernia (10cm x 08cm).On (b)(6) 2018, the patient underwent reoperation and was implanted with phasix onlay to repair the hernia recurrence.The study mesh was not removed.The patient was discharged to home on (b)(6) 2018.The ae is clinically assessed to be of moderate severity, possible related to the device, not related to the 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).
Additional Manufacturer Narrative
As reported, a patient with a medical/surgical history of hernia recurrence, was diagnosed with a hernia recurrence post implant of the xenmatrix surgical graft.The clinician has assessed the patient¿s postoperative course of hernia recurrence as possibly related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.Hernia recurrence is included as a possible complication in the adverse reactions section of the instructions-for-use, supplied with the device.Review of manufacturing records confirms product was manufactured to specification.This mdr represent the ae of hernia recurrence.An additional mdr has been submitted to represent the ae of surgical site infection.Not returned - remains implanted.

• 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: 15500921
• Report Number: 1213643-2022-00632
• Device Sequence Number: 1855849
• 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: 09/28/2022
• 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