MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	12/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during elective laparoscopic and open repair of incisional hernia on (b)(6) 2021, the patient was implanted with a ventrio st mesh (device #1).A ventralight st mesh (device #2) was used to extend the midline coverage.It was reported that, 9-months post-implant, the patient was diagnosed with an infection.As reported, during (b)(6) 2022, the patient was diagnosed with a colo-cutaneous fistula through the mesh, which was managed with ivabs, skin management and nutrition.In (b)(6) 2023, the patient underwent a laparotomy, excision of colo-cutaneous fistula, mesh and midline repair.
Additional Manufacturer Narrative
As reported, post-implant of the ventrio st mesh, the patient was diagnosed with an infection and subsequent fistula.Infection and fistula are known inherent risks of surgery.The information provided did not indicate a cause for the patient¿s postoperative course.Based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 44 units released for distribution in (b)(6) 2020.The adverse reactions section of the instructions-for-use (ifu) supplied with the device lists fistula formation and infection as possible complications.Regarding infection, the warning section of the ifu supplied with the device states that, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." this mdr represents the ventrio st mesh (device #1).An additional mdr was submitted to represent the ventralight st mesh (device #2).

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 16460534
• Report Number: 1213643-2023-00073
• Device Sequence Number: 12390928
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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: 12/28/2021
• Device Catalogue Number: 5950080
• Device Lot Number: HUDY1873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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 Sex: Female