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); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 1 year 7 months post implant of ventrio st, patient was diagnosed with hernia recurrence, mesh migration, adhesions and pain thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.This emdr represents the ventrio st (device #2).An additional supplemental emdr was submitted to represent the ventralex 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.H3 other text : not returned.
Event or Problem Description
Per plaintiff profile form (b)(4) : attorney alleges that the patient had adhesions, bowel/intestinal removal, infection, pain, hernia recurrence, bowel adherent to mesh, mesh separation and emotional injuries.Addendum per additional information provided: on (b)(6) 2015 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex st (device #1).Per operative notes, ¿hernia was identified.A ventralex mesh was placed under the fascia and sutured.¿ on (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventrio st (device #2) and removal of ventralex st (device #1).Per operative notes, ¿hernia sac and old mesh were encountered.A ventralex st mesh (device #1) and large hernia sac were completely removed.A ventrio st (device #2) was placed and tacked to the anterior abdominal wall.¿ on (b)(6) 2017 - patient was diagnosed with recurrent incarcerated ventral incisional hernia and pain thereby underwent open repair with the implant of ventrio st (device #3) and explant of ventrio st (device #2).Per operative notes, ¿after removal of hernia sac, the mesh was encountered which was pulled away from the left lateral fascial planes and then it was free-floating within the hernia itself.Adhesions were taken down in the right lateral part of the mesh and the ventrio st mesh (device #2) was explanted.Then, a piece of ventrio st (device #3) was placed and tacked to the anterior abdominal wall.¿ attorney alleges that the patient had adhesions, bowel/intestinal removal, infection, hernia recurrence, bowel adherent to mesh, mesh separation, pain and emotional injuries.

• 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: 19612657
• Report Number: 1213643-2024-093211
• Device Sequence Number: 15001940
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 08/28/2016
• Device Catalogue Number: 5950050
• Device Lot Number: HUYH0086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2014
• 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
• Patient Age: 43 YR
• Patient Sex: Female