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

Catalog Number	5950020
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Inflammation (1932); Scar Tissue (2060); Hernia (2240)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 year post implant of ventrio st, patient was diagnosed with hernia recurrence, adhesions, inflammation, abdominal pain & scar tissue thereby underwent removal of mesh.The instructions-for-use supplied with the device lists adhesions, inflammation and hernia recurrence 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-feb-2017) is considered to be a best estimate.This emdr represents the ventrio st (device #2).An additional supplemental emdr was submitted to represent the kugel patch (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.
Event or Problem Description
Per information provided: (b)(6) 2013 - patient was diagnosed with epigastric and incisional hernia thereby underwent laparoscopic converted into open repair with the implant of kugel patch (device #1).Per operative notes, ¿two hernias in the epigastric area with omentum in hernia sac was removed.The patient was found to have about 3 defects and some small pieces of fascia in between like bridges, made into single defect and kugel patch (device #1) was placed and sutured.¿ (b)(6) 2013 - patient was diagnosed with ventral hernia in epigastrium thereby underwent removal of kugel patch (device #1).Per operative notes, ¿the patient was found to have a ventral hernia in the epigastric area on the left side of the midline.The hernia sac was repaired using a piece of synthetic mesh and secured to the abdominal wall using interrupted sutures." (b)(6) 2017 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device #2).Per operative notes, ¿the old scar in the epigastric area and close to umbilicus was excised.The hernia is mainly localized more to the left side of the midline and the hernia sac was resected.Patient was found to have very thin layer of fascia and peritoneum and synthetic mesh, which was previously placed intraperitoneally, appears to be in pieces was removed.A ventrio st mesh (device #2) was placed and secured.¿ (b)(6) 2018 - patient was diagnosed with recurrent ventral incisional hernia, chronic abdominal pain thereby underwent robotic assisted repair with removal of mesh (device #2) and open repair with the implant of phasix mesh (device #3).Per operative notes, ¿the adhesions in the midline were very dense and numerous were lysed.A piece of heavyweight polypropylene mesh (device #2), just based on the local inflammatory reaction and response of the tissues to the mesh material, which was extremely thick and rigid.The previously placed mesh, and recurrent hernia defect were seen.Due to chronic pain and the severe inflammatory reaction, the entire mesh all along the left side of the abdominal wall up to the midline robotically and detached the mesh (device #2) completely from all peritoneal surfaces.A piece of phasix mesh (device #3) was trimmed, and then was placed in the subcutaneous pocket directly on top of the closed rectus fascia." attorney alleges that the patient had pain, hernia recurrence and emotional injuries.

• 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: 21239346
• Report Number: 1213643-2025-090037
• Device Sequence Number: 3627807
• Product Code: FTL
• UDI-Device Identifier: 00801741031519
• UDI-Public: (01)00801741031519(17)190228(10)HUBP1137
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/27/2025

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: 02/28/2019
• Device Catalogue Number: 5950020
• Device Lot Number: HUBP1137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG