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

Catalog Number	5954113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported per clinical trial (b)(4): on (b)(6) 2017 - subject patient underwent a primary laparoscopic midline umbilical hernia repair procedure.A bard/davol ventralight st mesh was placed in underlay fashion and was fixated using a non-bard/davol fixation device along with a non-bard/davol ti-cron mechanical suture with 4 fixation points.The patient was discharged to home on (b)(6) 2017.On (b)(6) 2018 - subject patient was diagnosed with midline umbilical hernia recurrence.On (b)(6) 2019 - subject patient underwent an open laparotomy procedure to repair the hernia recurrence and a permanent synthetic mesh was placed in a sandwich fashion and the patient was discharged to home on (b)(6) 2019.Per the study clinician, the reported adverse event has been assessed moderate severity, possibly related to the study device and possibly related to the procedure.The outcome for this ae is reported as recovered/resolved.
Additional Manufacturer Narrative
As reported, about eleven months post-implant of the ventralight st mesh, the patient was diagnosed with hernia recurrence.As reported, about one year later, the patient underwent hernia repair procedure.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 hernia repair surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.Not returned - remains implanted.

• Brand Name: VENTRALIGHT ST
• 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: 14434613
• Report Number: 1213643-2022-00234
• Device Sequence Number: 12177057
• Product Code: FTL
• UDI-Device Identifier: 00801741031595
• UDI-Public: (01)00801741031595
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/10/2022

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: 11/28/2018
• Device Catalogue Number: 5954113
• Device Lot Number: HUAX1846
• 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: 05/19/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 88 KG