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

Catalog Number	5950070
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per information provided: 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 manufacturing date (15-jun-2011) is considered to be a best estimate.This emdr represents the ventrio st (device #2).Additional supplemental emdr was submitted to represent the mesh ¿ composix kugel (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: (b)(6) 2003 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of composix kugel mesh (device #1).Per operative notes, ¿the patient noted to have omental adhesions in the hernia sac was reduced.A fascial defect was encountered.A medium composix kugel patch (device #1) was placed on top of the omentum and secured to the anterior abdominal wall using spiral tacking device.¿ (b)(6) 2012 - patient was diagnosed with ventral hernia thereby underwent open repair with the removal of mesh (device #1) and implant of ventrio st mesh (device #2).Per operative notes, ¿extensive adhesiolysis was performed.A upper ventral incision revealed distorted prior mesh (device #2) was excised.A oval ventrio st hernia patch (device #2) was placed and secured to the overlying peritoneum and fascia using sutures.¿ (b)(6) 2017 - patient was diagnosed with paraesophageal hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.(b)(6) 2019 - patient was diagnosed with eventration of anterior abdominal wall thereby underwent robotic assisted repair.Per operative notes, ¿adhesions to the anterior abdominal wall were taken down.The fascia had thinned out between the rolled edges of the previous mesh (device #2).Plicated the mesh from side to side completely fixing the eventration.¿.

• Brand Name: VENTRIO 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 ; 4018258495
• MDR Report Key: 21959006
• Report Number: 1213643-2025-090198
• Device Sequence Number: 9197507
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564(17)130628(10)HUVF0845
• 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): 05/05/2025

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: 06/28/2013
• Device Catalogue Number: 5950070
• Device Lot Number: HUVF0845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2011
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 136 KG