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 Code	Hernia (2240)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Alleged per clinical study dvl-he-020: on (b)(6) 2014, the subject patient underwent multiple recurrent ventral midline open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion on the intra-peritoneal region using a suture (maxon).Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved with sutures.The patient was discharged on (b)(6) 2014.Concomitant procedure includes lysis of adhesion(s) and prior mesh removal.As reported, during a physical examination on (b)(6) 2016, the patient was diagnosed with ventral midline hernia recurrence and confirmed through ct scan on (b)(6) 2016.On (b)(6) 2016, patient underwent a hernia repair procedure during which the device was partially explanted.Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved.The patient was discharged on (b)(6) 2016.The ae is clinically assessed to be of moderate severity, definitely related to the study 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, post implant of the xenmatrix graft , the patient with a history of recurrence hernia, was diagnosed with a recurrent hernia and underwent partial explant.The clinician has assessed the patient¿s postoperative course as definitely 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 surgery and is listed as a possible complication in the instructions-for-use supplied with the device.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in august 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: 15257808
• Report Number: 1213643-2022-00586
• Device Sequence Number: 20286411
• 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: 2014
• 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): 08/04/2022

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: 07/28/2016
• Device Catalogue Number: 1161935
• Device Lot Number: HUYG1507
• 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: 08/15/2014
• 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; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 185 KG