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

Catalog Number 0010218

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Necrosis (1971); Seroma (2069); Hernia (2240)

Event Date 06/19/2015

Event Type  Injury  

Manufacturer Narrative

As reported, about 20 months post-implant of bard/davol ventrio mesh, the patient was diagnosed with hernia recurrence and underwent surgical intervention with implant of a second mesh and without action reported to have been taken in regards to the mesh implanted in 2013.The clinician has assessed the patient¿s postoperative course as being ¿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 surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.As reported 5 years after the implant of the second mesh, the patient diagnosed with a seroma and necrosis which appears to have progressed into infected mesh, which resulted in at least partial explant of both implanted mesh.The cause of the seroma an necrosis can't be determined.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." this mdr represents the 2013 implanted ventrio mesh (device #1).Additional mdr was submitted to represent the 2015 implanted ventrio mesh (device #2).The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

Alleged per clinical trial dvl-he-020: 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.(b)(6) 2015, patient experienced incarcerated recurrent incisional hernia.(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 was placed (device 2).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.(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.(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: 14497375
• MDR Text Key: 293356827
• Report Number: 1213643-2022-00338
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016455
• UDI-Public: (01)00801741016455
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Catalogue Number: 0010218
• Device Lot Number: HUWG0536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male