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

Catalog Number	0010216
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(6): on (b)(6) 2016 - subject patient underwent multiple recurrent ventral hernia repair in the left lower quadrant (llq) using a bard/davol ventrio hernia patch.Fascia closure was performed and skin closure was achieved using staples.The patient was discharged on the same day.On (b)(6) 2018 - subject patient was diagnosed with a recurrent incisional hernia during a physical exam.On (b)(6) 2018 - subject patient underwent ventral hernia (llq) repair procedure for hernia recurrence.The patient was discharged on same day.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.On (b)(6) 2019 - subject patient was diagnosed with a recurrent incisional hernia.On (b)(6) 2019 - subject patient underwent ventral hernia repair procedure in the left lower quadrant (llq), during which the mesh was explanted.The patient was discharged on (b)(6) 2019.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about 2.2 years post-implant of the ventrio hernia patch, the patient was diagnosed with recurrent incisional hernia and underwent surgical repair.As reported, the ae has resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and to the index procedure, however, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair 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.This mdr represents the adverse event of recurrent hernia that occurred on (b)(6) 2018.An additional mdr was submitted to represent the adverse event of recurrent hernia that occurred on (b)(6) 2019.Not returned.

• 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: 14515355
• Report Number: 1213643-2022-00348
• Device Sequence Number: 20205775
• Product Code: FTL
• UDI-Device Identifier: 00801741016394
• UDI-Public: (01)00801741016394
• 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
• Device Explanted Year: 2019
• 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: 09/28/2017
• Device Catalogue Number: 0010216
• Device Lot Number: HUYJ0218
• 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: 11/22/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 103 KG