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

Catalog Number 0010212

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Necrosis (1971); Seroma (2069)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

As reported, about 5 years post-implant of bard/davol ventrio mesh, the patient was diagnosed with seroma, mesh infection and necrosis for which the mesh was partially explanted.The outcome of this aes are reported as recovering.The clinician has assessed the patient¿s postoperative course as being "definitely" related to the study device and definitely related to the index procedure, however, based on the information provided, no conclusion can be made.Mesh infection and seroma are known inherent risk of hernia repair surgery.The instructions-for-use, supplied with the device lists infection and seroma as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 195 units released for distribution in july, 2015.This mdr represents the 2015 implanted ventrio mesh (device #2).Additional mdr was submitted to represent the 2013 implanted ventrio mesh (device #1).Not returned - partially explanted.

Event Description

Alleged per clinical trial (b)(6): on (b)(6) 2013, the patient underwent multi-recurrent open ventral incisional hernia repair, during which a bard/davol ventrio hernia patch (device #1) was placed.Fascia and full skin closure was achieved.On (b)(6) 2015, patient experienced incarcerated recurrent incisional hernia.On (b)(6) 2015 patient admitted to the hospital.The recurrence resulted in reoperation.Patient underwent open ventral incisional hernia repair, during which a bard/davol ventrio hernia patch (device 2) was placed.As reported, no action was taken related to the previously implanted mesh (device 1).The patient was discharged to home on (b)(6) 2015.The ae (recurrence ¿ device 1) is clinically assessed to be serious and possibly related to the study device and possibly related to the procedure.(b)(6) 2019, a culture was obtained the culture tested positive for bacterial infection as gordonia.On (b)(6) 2020, patient developed chronic nonhealing abdominal wall with soft tissue necrosis and seroma (ae 2).The reported ae resulted in reoperation and partially removal of both mesh.On (b)(6) 2020, patient underwent additional surgical intervention, which included additional partial explant of both mesh, related to ¿chronic mesh infection¿ (ae 2).Ae 2 is clinically assessed to be definitely related to the study devices and definitely related to the procedure.

• Brand Name: VENTRIO MESH
• Type of Device: 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: 14497373
• MDR Text Key: 292820420
• Report Number: 1213643-2022-00339
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 0010212
• Device Lot Number: HUZF0068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male