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 Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2013 - subject patient underwent first time recurrent open ventral peri-umbilical hernia repair, during which a bard/davol ventralex hernia patch (device #1) was implanted.Fascia and full skin closure was achieved using staples.The patient was discharged on the same day.B)(6) 2015 - subject patient was diagnosed with ¿recurrent incisional ventral hernia (upper midline)¿.(this ae was assessed as not being related to the previously implanted mesh device).(b)(6) 2015 - subject patient underwent open midline peri-umbilical hernia repair, during which bard/davol ventrio mesh (device #2) was implanted; fascia and full skin closure was achieved.The patient was discharged on the same day.(b)(6) 2018 - subject patient was diagnosed with ¿recurrent chronically incarcerated ventral hernia¿.(b)(6) 2018 - ct scan was performed and confirmed hernia recurrence; patient was also diagnosed with partial small bowel obstruction.(b)() 2018 - subject patient underwent open ventral peri-umbilical repair for hernia recurrence and partial small bowel obstruction, during which both the meshes were explanted.Patient discharged from the hospital on (b)(6) 2018.Per the study clinician, the reported adverse event hernia recurrence and the partial small bowel obstruction was possibly related to both of the study devices and possibly related to the index procedures.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, 30 months post-implant of bard/davol ventrio mesh, the patient was diagnosed with an incarcerated hernia with partial small bowel obstruction and underwent surgical intervention which included mesh removal.As reported the ae has resolved.The clinician has assessed the patient¿s postoperative course as being "possibly" related to the study device and possibly to the procedure, however, based on the information provided, no conclusions can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.Review of manufacturing records confirms product was manufactured to specification.This mdr reports the ventrio mesh (device #2), and additional mdr will be submitted to report ventralex hernia patch (device #1) not returned - mesh explanted.

• 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: 14493002
• Report Number: 1213643-2022-00321
• Device Sequence Number: 6008649
• 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: 2015
• Device Explanted Year: 2018
• 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): 05/16/2022

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: 02/28/2019
• Device Catalogue Number: 0010215
• Device Lot Number: HUZG1282
• 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: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 86 KG