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

Catalog Number	5954460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with recurrent incarcerated ventral incisional hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #1).Per operative notes, ¿the hernia sac was dissected and reduced.A bard composix e/x mesh (device #1) was placed in an underlay fashion, extracorporeally sutures placed circumferentially around the mesh.It was rolled up and placed in the peritoneal cavity and then fixed circumferentially using securstrap device.¿ (b)(6) 2016 - patient was diagnosed with abdominal pain, swelling, recurrent ventral incisional hernia with complications of previously placed mesh thereby underwent open repair with the implant of ventralight st mesh (device #2) and explant of composix e/x mesh (device #1).Per operative notes, ¿the composix e/x mesh (device #1) was carefully dissected off with sutures and removed.There were two portions of mesh, one appeared to be dual layer of gore-tex mesh and other was a disc of mesh that was secondarily placed had a cloudy fluid associated with it, also very thickened and contracted.It was elected to repair the abdominal midline using a dual layer prolene mesh the mesh was cut and placed overlapping the fascial margins and sutured.¿ (b)(6) 2019 - patient was diagnosed with adhesions, recurrent ventral incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #3).Per operative notes, ¿the old piece of ventralight st (device #2) that was encompassed had multiple adhesions.The defect was identified and closed with sutures.A ventralight st mesh (device #3) was placed with transfascial sutures and secured with absorbable tacks using the absorbatack tacker.¿ attorney alleges that the patient had adhesions, mesh shrinkage, infection, pain, seroma, swelling, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 years 10 months post implant of ventralight st mesh, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.Note, the manufacturing date (15-oct-2016) is considered to be a best estimate.This emdr represents the ventralight st mesh (device #2).Additional supplemental emdr was submitted to represent the composix mesh e/x (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.

• Brand Name: VENTRALIGHT ST 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 ; 4018258495
• MDR Report Key: 20817900
• Report Number: 1213643-2024-094830
• Device Sequence Number: 8691358
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)181028(10)HUAX1034
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 10/28/2018
• Device Catalogue Number: 5954460
• Device Lot Number: HUAX1034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2016
• 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
• Patient Age: 66 YR
• Patient Sex: Male