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

Catalog Number	5950060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Injury (2348); Disability (2371); Bowel Perforation (2668); Fibrosis (3167)
Date of Event	05/17/2016
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 ventrio st(device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two (2) unspecified bard/davol ventrio st(device #1 and device #2 )on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventrio st(device #1 and device #2).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.".
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two (2) unspecified bard/davol ventrio st(device #1 and device #2 )on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventrio st(device #1 and device #2).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." addendum per additional information provided: (b)(6) 1998 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with composix mesh (device #1).Per operative notes, ¿the fascial hernia defects were repaired with a piece of composix mesh (device #1) and secured using sutures.¿ (b)(6) 1999 - patient was diagnosed with recurrent ventral hernia thereby underwent repair.Per operative notes, ¿excised old scar tissue and freed the hernias surrounded the mesh (device #1).The largest hernia noted in right upper quadrant portion of mesh and bowel adherent to undersurface of mesh.There was bowel obstruction was secondary to hernia.The defects were repair with two synthetic meshes and secured using sutures.¿ (b)(6) 2002 - patient was diagnosed with small bowel obstruction thereby underwent exploratory laparotomy with resection of some mesh (device #1).Per operative notes, ¿small bowel was densely adherent to a layer of underlying mesh appeared to be the point of obstruction.Resected them and as well as some of mesh (device #1) on right lateral portion.¿ (b)(6) 2012 - patient was diagnosed with multiple recurrent incarcerated ventral hernias thereby underwent open repair with implant of ventrio st meshes (device #2 & #3).Per operative notes, ¿there were extensive amounts of large and small bowel herniated into multiple defects and adherent to previously placed mesh (device #1).Adhesions were lysed and hernia sacs were separated by a bridge of fascia without excising the mesh completely.Component separation was done, a preformed ventrio st mesh (device #2) was placed under this and tacked.The upper abdominal hernia was then repaired with a piece of dual ventrio st mesh (device #3) which placed into abdominal cavity and tacked.¿ (b)(6) 2016 - patient was diagnosed with infected abdominal wall mesh secondary to small bowel fistula thereby underwent repair with mesh removal.Per operative notes, ¿there were two layers of mesh that had to be cut through.Entered a pocket of pus near umbilicus.There was hole in small bowel that was adherent to mesh, and they were lysed along with fistula.The mesh (device #1, #2 & #3) was then excised off.¿ attorney alleges that the patient had abscess, adhesions, bowel perforation, bowel removal, fistula, mesh migration, pain, infected mesh and hole in small bowel adherent to mesh.
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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 4 years, 3 months post implant of ventrio st mesh, patient was diagnosed with bowel perforation, infection, fistula, abscess, inflammation, adhesions and fibrosis thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists bowel perforation, infection, fistula, inflammation and adhesions as possible complications.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device".A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-may-2011) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventrio st (device #3).Additional emdr was submitted to represent the bard/davol mesh ¿ composix (device #1) and an additional supplemental emdr was submitted to represent the ventrio st (device #2).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.; 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: 8919955
• Report Number: 1213643-2019-07395
• Device Sequence Number: 14052581
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)130528(10)HUVE0185
• 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
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 05/28/2013
• Device Catalogue Number: 5950060
• Device Lot Number: HUVE0185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2011
• 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; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 110 KG