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

Catalog Number	5950040
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Fibrosis (3167)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 years 3 months post implant of ventrio st, patient was diagnosed with hernia recurrence, adhesions, fibrosis and mesh deformation thereby underwent repair with removal of mesh.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.Note, the manufacturing date (15-may-2012) is considered to be a best estimate.This emdr represents the ventrio st (device #2).Additional supplemental emdr was submitted to represent the ventrio st (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: not returned.
Event or Problem Description
Per information provided: on (b)(6) 2012 - patient was diagnosed with incarcerated ventral incisional hernia thereby underwent laparoscopic repair with the implant of two ventrio st (device #1 & device #2).Per operative notes, ¿a large amount of adhesions were taken down from the abdominal wall.A ventrio st (device #1) was placed and secured using sutures.Then a ventrio st (device #2) was placed at the lower point of the hernia defect and secured by sutures.¿ on (b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventrio st (device #3) and removal of ventrio st (device #1 & device #2).Per operative notes, ¿numerous dense adhesions in the right upper quadrant were taken down.There was a small hernia defect identified in an area where the ventrio st (device #1 & device #2) had curled inward away from the abdominal wall was removed.Then a ventrio st (device #3) was placed and secured by sutures.¿ attorney alleges that the patient had adhesions, pain, hernia recurrence, infection and emotional injuries.It was also alleged that the patient had mesh had curled inward away from the abdominal wall.

• Brand Name: VENTRIO ST
• 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: 21363282
• Report Number: 1213643-2025-090075
• Device Sequence Number: 8416751
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)140528(10)HUWE0649
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 05/28/2014
• Device Catalogue Number: 5950040
• Device Lot Number: HUWE0649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2012
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 109 KG