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

Catalog Number	0010214
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.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.Not returned.
Event or Problem Description
The patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.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.".
Additional Manufacturer Narrative
At this time no conclusions can be made.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 8 years post implant of ventrio mesh, patient was diagnosed with hernia recurrence, obstruction, fistula, abscess, adhesions, pain, mesh deformation thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence, fistula, adhesions and pain as possible complications.Note, the manufacturing date (15-jun-2009) is considered to be a best estimate.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
The patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6)2010.As reported, the patient is making a claim for an adverse patient outcome against the ventrio.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)2010 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, ¿the hemia sac contained entire transverse colon and omentum was dissected away.Some of the omentum was excised.An ventrio hernia patch (device #1) was attached circumferentially with interrupted sutures." (b)(6)2018 - patient had pain and was diagnosed with fistula, recurrent incisional hernia, obstruction thereby underwent open repair with the removal of ventrio mesh (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿multiple areas of incisional hernia above and below the area of the colocutaneous fistula were noted.On the right, there was an bunching up of the mesh (device #1) was excised lateral to the area of contamination, abscess and anterior abdominal wall.Area of the colocutaneous fistula and mesh were freed up from all of the underlying small bowel, omentum and large bowel.Similar process on right side was performed on the left side of the anterior abdominal wall as well.There was a small bowel obstruction because of the density of the adhesions to the undersurface of the colocutaneous fistula.The colocutaneous fistula along with the small bowel were removed.The hernia was seen.The openings in the posterior fascia were closed with synthetic mesh placed intraabdominally using sutures.A piece of phasix mesh (device #2) was placed over the entire anterior abdominal contents and fixed superiorly and inferiorly as well.A synthetic mesh was placed into the preperitoneal space and anchored with sutures.¿ attorney alleges that the patient had abscess, adhesions, bowel removal, fistula, hernia recurrence and pain.

• Brand Name: VENTRIO MESH
• 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 ; 4018258538
• MDR Report Key: 8418439
• Report Number: 1213643-2019-01693
• Device Sequence Number: 11098025
• Product Code: FTL
• UDI-Device Identifier: 00801741016417
• UDI-Public: (01)00801741016417(17)100628(10)HUTF1470
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 06/28/2010
• Device Catalogue Number: 0010214
• Device Lot Number: HUTF1470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2009
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 107 KG