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

Catalog Number	5950080
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	04/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2014, the patient underwent surgery for implant of an unspecified bard/davol ventrio st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.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 2 years 2 months post implant of ventrio st, patient was diagnosed with hernia recurrence, obstruction, adhesions and scar tissue thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.Updated fields: a2, b2, b3 (date of event), b4, b5, b6, b7, d4 (product catalog no, corporate lot no, expiry date, udi no), d.6b (date of explant), g1, g3, g6, h2, h6, h10.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.H3 other text: not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2014, the patient underwent surgery for implant of an unspecified bard/davol ventrio st.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: on (b)(6) 2014 - patient was diagnosed with multiple abdominal wall ventral hernias thereby underwent open repair with implant of ventrio st mesh.Per operative notes, "dissected the hernia sac free down to the fascial edges.A 20x15 cm piece of ventrio st patch was placed and sutured." on (b)(6) 2016 - patient was diagnosed with internal hernia and bowel obstruction thereby underwent open repair with removal of mesh.Per operative notes, "found very dense adhesions from the bowel to the undersurface of the previously placed synthetic mesh.Detached the small bowel and large bowel which was densely adherent to the mesh and a piece of biological mesh was placed." attorney alleged that the patient had adhesions, bowel obstruction, infection, mesh shrinkage, nerve damage, pain, hernia recurrence and emotional injuries.It was also alleged that the patient had bilateral component separation, wound care, wound vac and post operative bleeding.

• 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: 9274581
• Report Number: 1213643-2019-10578
• Device Sequence Number: 1671072
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)151128(10)HUXK0919
• Combination Product (Y/N): N
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 11/11/2024

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: 11/28/2015
• Device Catalogue Number: 5950080
• Device Lot Number: HUXK0919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 43 YR
• Patient Sex: Male