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

Catalog Number	5950050
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.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.¿ it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the ventrio st.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.¿ it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2017 - patient was diagnosed with incarcerated ventral incisional hernia thereby underwent open repair with implant of ventrio st mesh.Per operative notes, ¿the sac was dissected, and the contents were reduced.A ventrio st mesh was placed and sutured.¿ (b)(6) 2021- patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the explant of ventrio st mesh and implant of biological mesh.Per operative notes, ¿the ventrio st mesh was excised circumferentially and removed.A biological mesh was placed in an underlay fashion and sutured.¿ attorney alleges that the patient had adhesions, pain, hernia recurrence and emotional injuries.It was also alleged that patient underwent mesh removal and mesh had torn.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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"; however, no details have been provided.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 provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 3 years 5 months post implant of ventrio st, patient was diagnosed with hernia recurrence, adhesion, pain and mesh torn thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence, adhesion and pain as possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-dec-2016) is considered to be a best estimate.Updated fields: a2, a4, b2, b3, b4, b5, b6, b7, d4 (product catalog no, corporate lot no, expiry date, udi no), d6b (date of explant), g3, g6, h2, h4, 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.

• 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: 14508096
• Report Number: 1213643-2022-94082
• Device Sequence Number: 5513250
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)190128(10)HUAZ1365
• 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: 2017
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 01/28/2019
• Device Catalogue Number: 5950050
• Device Lot Number: HUAZ1365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 110 KG