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); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges additional surgical intervention, 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." attorney alleges that the patient experienced emotional distress and the device was defective.However, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol ventrio st (device #1).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol ventrio st meshes on (b)(6) 2015 and (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against both the ventrio st meshes.The attorney alleges that the patient underwent surgery for the removal of hernia mesh product on (b)(6) 2016 which was implanted on (b)(6) 2015.As reported, 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." attorney alleges that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges additional surgical intervention, 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." attorney alleges that the patient experienced emotional distress and the device was defective.However, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents bard/davol ventrio st (device #2).An additional emdr was submitted to represent the bard/davol ventrio st (device #1).Should additional information be provided a supplemental emdr will be submitted.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.H11: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.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-mar-2015) 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 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol ventrio st meshes on (b)(6) 2015 and (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against both the ventrio st meshes.The attorney alleges that the patient underwent surgery for the removal of hernia mesh product on (b)(6) 2016 which was implanted on (b)(6) 2015.As reported, 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." attorney alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2015 - patient was diagnosed with incisional hernia & umbilical hernia thereby underwent open repair with implant of ventrio st (device #1).Per operative notes, ¿the 2 hernia defects with incarcerated omentum were identified.The incarcerated omentum was reduced.The hernia defects were dissected free.A ventrio st (device #1) was placed and tacked.¿ (b)(6) 2016 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with excision of mesh (device #1) and implant of ventrio st (device #2).Per operative notes, ¿the prior mesh was identified to be folded up and torn free causing recurrence.The prior mesh (device #1) was resected completely.The hernia sac with incarcerated part of omentum was identified and resected after lysis of adhesions.A ventrio st (device #2) was placed and tacked.¿ (b)(6) 2019 - patient was diagnosed with small bowel obstruction thereby underwent laparoscopic to open repair with excision of mesh (device #2).Per operative notes, ¿the omental and small bowel densely adherent to prior mesh was taken down.The prior mesh was wrinkled causing obstruction.After extensive lysis of adhesions, the small bowel obstruction was released.The prior mesh (device #2) was excised completely.¿.

• 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: 9404678
• Report Number: 1213643-2019-11654
• Device Sequence Number: 2166892
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564(17)170328(10)HUZC0149
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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: 03/28/2017
• Device Catalogue Number: 5950070
• Device Lot Number: HUZC0149
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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; Disability
• Patient Age: 69 YR
• Patient Sex: Female