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	06/23/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged per clinical trial dvl-he-020: on (b)(6) 2014, the patient underwent primary ventral midline open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in underlay fashion intra-peritoneally and fixated using sutures.Fascia was achieved using interrupted sutures and full skin closure was achieved using sutures.The patient was discharged to home on (b)(6) 2014.Concomitant procedure includes ileostomy closure and creation of a colostomy.On (b)(6) 2015, the patient was diagnosed with reducible parastomal hernia recurrence at right upper quadrant (ruq).The ae is clinically assessed to be of mild severity, possibly related to the study device and not related to the procedure and recovering/resolving.The reported adverse event does not meet the definition of an sae (serious adverse event).
Additional Manufacturer Narrative
As reported, post implant of the xenmatrix, the patient was diagnosed with reducible parastomal hernia recurrence.The clinician has assessed the patient¿s postoperative course as possibly related to the study device and not related to the procedure and the ae is recovering/resolving.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.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 june,2014.

• 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: 15181883
• Report Number: 1213643-2022-00573
• Device Sequence Number: 5809177
• 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): 07/20/2022

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: 06/28/2016
• Device Catalogue Number: 1162025
• Device Lot Number: HUYE1324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG