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

Catalog Number	0010215
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per provided medical records: (b)(6) 2015 - patient who had underwent cholecystectomy a year before was diagnosed with incisional hernia in the cholecystectomy site and underwent open repair with implant of ventrio mesh (device #1).Per the operative notes," hernia sac was then identified.Fascial defect was about 4 cm, so a 3 inch or 7.6 centimeter round mesh (ventrio mesh device #1) was chosen.This was inserted into the defect and then sutured with #1 vicryl to the fascial edges." (b)(6) 2015 - patient had severe persistent pain in previous surgery area, was diagnosed with recurrent incisional hernia and underwent open repair with implant of ventrio mesh (device #2).Per the operative notes, ¿the mesh was then reached, and it really was not bunched up as anything noticeable.Old mesh (device #1) was removed using cautery.An 11 x 14 oval mesh (ventrio mesh device #2) was then chosen and sutured¿.(b)(6) 2016 - patient was diagnosed with recurrent ventral hernia and underwent open repair using a component separation.Per the operative notes, " there were a few adhesions of small bowel to the abdominal wall in this area and there was a mesh (ventrio mesh, device #2) from a previous repair which was present, and this was excised.It was really fairly balled up and wrapped in omentum and so was not adherent to the bowel in any way.It was taken out.The hernia sac was excised.We were able to proceed with a component separation.This was then reinforced with a polypropylene mesh.This was a large polypropylene mesh which was placed on top of the posterior rectus sheath and secured in place with a few vicryl sutures.".
Additional Manufacturer Narrative
Based on the available information, no conclusions can be made.Based on medical records provided about 4 months post implant of the ventrio mesh, patient was diagnosed with hernia recurrence, and underwent repair.Per explant operative notes, the mesh was "fairly balled up and wrapped in omentum".The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the ventrio mesh (device #2).A supplemental emdr was submitted for the ventrio mesh (device #1).Not returned.

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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 ; 4018258495
• MDR Report Key: 16613632
• Report Number: 1213643-2023-091178
• Device Sequence Number: 20038141
• Product Code: FTL
• UDI-Device Identifier: 00801741016424
• UDI-Public: (01)00801741016424
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2023

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: 09/28/2017
• Device Catalogue Number: 0010215
• Device Lot Number: HUYH1329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2014
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 145 KG