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

Catalog Number	5954680
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 4 years post implant of ventralight st mesh, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with explant of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This emdr represents the ventralight st mesh (device #3).An additional supplemental emdr was submitted to represent the ventralex mesh (device #1) and an emdr to represent the ventrio mesh (device #2).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 information provided by patient's attorney: (b)(6) 2011 - patient was diagnosed with incisional ventral hernia (x2) thereby underwent open repair with the implant of ventralex mesh (device #1) and ventrio mesh (device #2).Per operative notes, ¿the compound hernia sac was found and freed from attachments.Found additional defect inferiorly and anteriorly.Previous mesh that had been stapled had pulled apart.Exposed the fascial defect and put a large piece of ventralex oval mesh (device #1) circumferentially.The inferior ventral defect with incarcerated bowel and omentum were dissected.The fascial defect in the subxiphoid was much smaller, it was able to fully be occluded with a large ventralex kugel patch (ventrio - device #2) and sewed.¿ (note, no product identifiers provided for previous mesh).(b)(6) 2014 - during hospital visit patient was diagnosed with hernia recurrence.(b)(6) 2014 - patient was diagnosed with incarcerated recurrent ventral hernia (x2) and abdominal pannus thereby underwent repair with explant of the dislodged mesh (device #2), lysis of adhesions and panniculectomy.Per operative notes.¿fair amount of small and large bowel incarcerated ventral hernias was encountered at the right side below umbilicus and in the midline into the left.A previously placed kugel mesh (ventrio - device #2) was found and removed.The fascial defect was repaired with a biological mesh.¿ (note, there was no mention of device #1 during the procedure).(b)(6) 2015 - patient was diagnosed with small and infraumbilical hernia recurrence below the previous repair site.(b)(6) 2016 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of ventralight st (device #3).Per operative notes ¿hernia defect located mostly on the left and had multiple defects of at least 4 defects communicating with 1 large defect in middle.All the defects were connected to a large defect and repaired with polypropylene mesh with physiologic barrier (ventralight st - device #3).¿ (note, there was no mention of device #1 during the procedure).(b)(6) 2020 - during hospital visit patient was diagnosed with recurrent abdominal hernia.(b)(6) 2020 - patient was diagnosed with recurrent large ventral incisional hernia and panniculitis thereby underwent repair with explant of old mesh (device #1 & #3) and panniculectomy.Per operative notes, ¿a large ventral hernia found between anterior rectus sheath bilaterally, required a bilateral component separation in order the reconstruct the anterior abdominal wall and to provide facial closure.All adhesions throughout the abdominal cavity were lysed.A piece of biological mesh was then used in retrorectus space and sutured.¿ (note, it was unclear which was explanted during the procedure).Attorney alleges that the patient had adhesions, pain and hernia recurrence.

• 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: 18509413
• Report Number: 1213643-2024-090062
• Device Sequence Number: 15485188
• Product Code: FTL
• UDI-Device Identifier: 00801741031656
• UDI-Public: (01)00801741031656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2024

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: 02/28/2018
• Device Catalogue Number: 5954680
• Device Lot Number: HUAN1087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/13/2024
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 137 KG