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

Catalog Number	5950040
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	12/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device #1) per operative notes, ¿adhesions from omentum were removed.A ventrio st mesh (device #1) was placed subfascial, sutured and secured.¿ (b)(6) 2012 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device #2) and explant of ventrio st mesh (device #1).Per operative notes, ¿the previously placed ventrio st mesh (device #1) was noted to be lifted from left side of the fascia, and it was removed out completely.The adhesions were removed, and ventrio st mesh (device #2) was placed intraabdominally and sutured".(b)(6) 2015 - patient was diagnosed with large ventral recurrent hernia in the right abdominal wall thereby underwent open repair.Per operative notes, ¿scarring was noted in the right upper quadrant.Hernia was noted above the umbilicus to the left of the midline and all adhesions were removed.A piece of mesh (device #2) was noted in the right lower abdomen.A synthetic mesh was placed and secured by sutures.¿ attorney alleged that the patient had adhesions, pain.It is also alleged that the mesh removed because it was found to have lifted up on left side.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the date of manufacturing (15-dec-2012) as considered to be a best estimate date.This emdr represents ventrio st (device #2).An additional supplemental emdr was submitted to represent 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.

• Brand Name: VENTRIO ST
• Common Device Name: SUGICAL 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 ; 4018258495
• MDR Report Key: 21917105
• Report Number: 1213643-2025-090176
• Device Sequence Number: 8669419
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)140728(10)HUWG1717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: 07/28/2014
• Device Catalogue Number: 5950040
• Device Lot Number: HUWG1717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2012
• 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: 63 YR
• Patient Sex: Male