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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio st(device #2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol composix e/x (device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x (device #1) and an unspecified bard/davol ventrio st (device #2) on (b)(6) 2009 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x (device#1) and ventrio st (device #2).The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x(device #1) and an unspecified bard/davol ventrio st(device #2) on (b)(6) 2009 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x(device#1) and ventrio st(device #2).The attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." addendum per additional information provided: (b)(6) 2009 ¿ patient was diagnosed with midline ventral hernia thereby underwent open repair with the implant of composix e/x mesh (device 1).Per op notes, ¿a composix e/x mesh (device 1) was placed into preperitoneal space just below fascial level and sewed to rectus muscle using sutures.¿ (b)(6) 2011 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of mesh (device 1).Per op notes, ¿two pieces of mesh (device 1) were dissected out which was all wadded up.The defect was noted, and a large sheet of synthetic mesh was placed underneath and circumferentially tacked using sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device 2).Per op notes, ¿the synthetic mesh was pulled out from abdominal was bulged up.A sheet of ventrio st mesh (device 2) was placed underneath the abdominal wall and tacked.¿ (b)(6) 2015 ¿ patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with the implant of unknown mesh.Per op notes, ¿multiple scar tissue was noted.Adhesions were taken down.A small defect was found superior to the mesh.The one edge of mesh (device 2) was rolled around slightly.A mesh was placed to cover area and tacked.¿ (note: there is no product identifier provided for the mesh implanted during this procedure.Hence, it will be considered as unknown).
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio st(device #2)may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this supplemental emdr is submitted to document additional 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-sep-2011) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio st (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix e/x (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.

• 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: 8546959
• Report Number: 1213643-2019-03354
• Device Sequence Number: 1730556
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564(17)130928(10)HUVI0858
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 11/27/2025

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: 09/28/2013
• Device Catalogue Number: 5950070
• Device Lot Number: HUVI0858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2011
• 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: Disability; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male