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

Catalog Number	1162025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per clinical trial(b)(4): on (b)(6) 2014, the patient underwent first time recurrent incisional midline open hernia (20 cm x 8 cm) repair procedure, during which a xenmatrix surgical graft was trimmed and placed in underlay fashion intra-peritoneally using anterior component separation technique (cst) method, fixated using non-bard/davol maxon suture.Fascia was achieved using non-bard/davol vicryl interrupted stitch and full skin closure was achieved using sutures.Concomitant procedure includes panniculectomy, lysis of adhesions and bowel resection.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2022, the patient was diagnosed with incisional midline hernia recurrence (1cm x 7cm) and confirmed through ct scan which was performed on same day.As reported, the patient underwent open midline incisional hernia recurrence repair procedure on (b)(6) 2022 with the implant of unknown absorbable synthetic mesh and placed in onlay fashion.The patient was discharged to home on (b)(6) 2022.The ae is clinically assessed to be possibly related to the study device and possibly to the procedure.This has been assessed as a serious adverse event of moderate severity.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the definition of uade (unidentified adverse device event).
Additional Manufacturer Narrative
As reported, a patient was diagnosed with a hernia recurrence post implant of the xenmatrix surgical graft and underwent reoperation to repair hernia recurrence.The clinician has assessed the patient¿s postoperative course of hernia recurrence as possibly related to the study device and possibly 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 and included as a possible complication in the adverse reactions section of the instructions-for-use (ifu), 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 (b)(4) was previously submitted to represent the ae of abscess.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: 15536184
• Report Number: 1213643-2022-00639
• Device Sequence Number: 14773814
• Product Code: FTM
• UDI-Device Identifier: 00801741031465
• UDI-Public: (01)00801741031465
• 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: 2014
• 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): 09/28/2022

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: 01/28/2016
• Device Catalogue Number: 1162025
• Device Lot Number: HUXL1249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2014
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 98 KG