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

Catalog Number	5954810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Scar Tissue (2060); Hernia (2240)
Date of Event	01/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2014 - patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of ventralex st (device #1).Per operative notes, ¿two hernias one in the right umbilicus and above midline were identified, both hernia sacs were excised.A ventralex st (device #1) was placed and sutured." (b)(6)2017 - patient was diagnosed with recurrent incarcerated incisional hernia, small bowel obstruction involving old mesh thereby underwent open repair with removal of ventralex st (device #1) and implant of ventralight st mesh (device #2).Per operative notes, ¿the small bowel was densely adhered to the old mesh (device #1), removing the bowel from the mesh keeping the mesh off it and removing in its entirety.Adhesions were taken down and a ventralight st mesh (device #2) was placed into the defect and sutured." (b)(6)2018 - patient was diagnosed with enterocutaneous fistula thereby underwent explant of ventralight st mesh (device #2).Per operative notes, ¿the midline scar was removed.The enteric fistula was right in the middle of the mesh (device #2).Adhesions were taken down and ventralight st mesh (device #2) was removed.The fistulous area was then resected, and anastomosis was performed." (b)(6)2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of biosynthetic mesh, abdominal wall reconstruction, resection of small bowel with previous enterocutaneous fistula.Per operative notes, ¿the hernia sacs were dissected out.Once adhesions were taken down, a segment of small bowel densely adhered to the hernia sac where the previous enterocutaneous fistula had been removed and anastomosis was performed.A biosynthetic mesh was placed and sutured." (b)(6)2019 - patient was diagnosed with minimal drainage out of his fistula.(b)(6)2019 - patient was diagnosed with colocutaneous fistula thereby underwent removal of biosynthetic mesh.Per operative notes, ¿the chronic fistula around the area of mesh was incised.The mesh was removed in its entirety taking down the adhesions." attorney alleged that the patient had abscess, adhesions, bowel obstruction, bowel removal, fistulae, infection, mesh migration, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 5 months post implant of ventralight st mesh, patient was diagnosed with fistula, hernia recurrence, adhesions and scar tissue thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists fistula, hernia recurrence and adhesions as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This supplemental emdr represents the ventralight st mesh (device #2).Additional 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.

• 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: 21686005
• Report Number: 1213643-2025-090133
• Device Sequence Number: 18325574
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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 Catalogue Number: 5954810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• 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: 50 YR
• Patient Sex: Male