MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MODIFIED KUGEL PATCH; SURGICAL MESH

Catalog Number 0115812

Device Problem Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

As reported, about 6 years post-implant of the bard/davol modified kugel patch, the patient experienced an infection, and based on the reported description, a fistula that incorporated the mesh's recoiling ring which was reported as having been folded/material deformation.The patient underwent surgical intervention for mesh explant.The explanted mesh has been returned.Evaluation: the returned implant was heavily contaminated with tissue ingrowth.The recoil ring is exposed and is separated.The exposed end has blackened in color.Visual evaluation finds the ring separation was caused by cautery.This appears to have been to facilitate removal of during the mesh explant procedure.One end is physically blackened from applied heat, with considerable heating and melting of material.The opposite side of the separation is browned from application of heat.This section was not as melted but appears it was pulled away from the melted section to separate the ring.Separation is on the ring in an area that was somewhat kinked.This separation was not at the manufacturing weld area which was visualized and remains intact.Patient had post-op complications with device in vivo for more than 6 years.The contraction of the mesh in the anatomy appears to have resulted in material deformation.No manufacturing anomalies were found.Fistula formation and infection are known inherent risks of surgery and listed as potential complication in the adverse event section of the ifu supplied with the device.This mdr represents the modified kugel mesh (device 2) implanted in 2015.An additional mdr has been submitted to represent the kugel mesh (device 1) implanted in 2009.

Event Description

As reported, during an abdominal wall scar hernia repair procedure in 2009, the patient underwent implant of a bard/davol kugel patch (device 1).As reported, on (b)(6) 2015, the patient underwent repair of a recurrent open ventral incisional hernia during which the kugel patch was removed and a bard/davol modified kugel patch (device 2) was implanted.As reported, on (b)(6) 2021 the mesh (device 2) was explanted because of suspected mesh infection and fistula formation.As reported, upon examination of the explanted mesh, it was noted that the recoiling ring was folded and stuck in the intestinal tract.

• Brand Name: MODIFIED KUGEL PATCH
• Type of Device: 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: 12408297
• MDR Text Key: 269524670
• Report Number: 1213643-2021-20297
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030802
• UDI-Public: (01)00801741030802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 0115812
• Device Lot Number: HUYG2097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 66