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

Catalog Number	0010215
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2016 - the subject patient underwent first-time recurrent open periumbilical ventral hernia repair procedure, during which a bard/davol ventrio mesh was placed in underlay fashion on the intra-peritoneal region using a non-bard/davol mechanical fixation device and sutures.Fascia and full closure was achieved with sutures and adhesive skin closure.The patient was discharged on (b)(6) 2016.On (b)(6) 2017, the patient was diagnosed with "subcostal incisional hernia unrelated to index procedure".Regarding this diagnosis the information states "subj.Required reop due to new hernia location but unrelated to index procedure".As noted the patient was hospitalized from (b)(6) 2017.On (b)(6) 2018 - ct scan was performed and confirmed with hernia recurrence (size 3cm x 1cm) associated with the ventrio mesh implant.On (b)(6) 2018 - subject patient underwent an open ventral periumbilical recurrent hernia procedure for hernia recurrence due to 3cm opening of mesh where mechanical fixation failed to secure the mesh in the abdominal wall from previous hernia procedure.Full closure was achieved.The patient was discharged from the hospital on the same day.This ae is clinically assessed to be moderate in severity, not related to the study device and possibly related to the procedure.As reported, the outcome of this ae is recovered/resolved.
Additional Manufacturer Narrative
As reported, approximately 2 years post-implant of the ventrio mesh, the patient was diagnosed with hernia recurrence due to failure of the (non-bard/davol) mechanical fixation used during the index procedure.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being not related to the study device and possibly related to the index 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.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 173 units released for distribution in october, 2015.Not returned - remains implanted.

• Brand Name: VENTRIO MESH
• Common Device Name: 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: 14517071
• Report Number: 1213643-2022-00350
• Device Sequence Number: 6466358
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/19/2022

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: 03/28/2019
• Device Catalogue Number: 0010215
• Device Lot Number: HUZH2328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2015
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 76 KG