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

Catalog Number 0010205

Device Problems Bent (1059); Break (1069); Material Deformation (2976)

Patient Problem Hernia (2240)

Event Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

It is reported that the sample is being returned for evaluation; however has not been received to date.At this time no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction of the ifu as a possible complication.If / when the sample is returned and the evaluation has been completed a supplemental mdr will be submitted.The information provided by bard 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 bard.

Event Description

The following was reported to davol: (b)(6) 2011 - the patient was implanted with a bard composix kugel hernia patch for the repair of a hernia.On (b)(6) 2017 - the patient underwent repair of a recurrent hernia with explant of the bard composix kugel hernia patch.As reported there was a retraction of the prosthesis which was alleged to have caused a recurrence of the abdominal rupture.The surgeon reports that the recurrence was possibly due to a defect in the prosthesis or to bad fixation of the prosthesis.

Manufacturer Narrative

This is an addendum to the initial mdr to document the sample return and evaluation.The explanted mesh implant was returned in a contaminated state.The device had been implanted in the patient for almost 6-years.It shows signs of significant contraction and material deformation.Visual examination identified areas within the mesh side layer, that had been cut during the process of removal and are not a defect in the mesh.The sample evaluation identified 8 suture fixation points with sutures still affixed to the mesh.The surgeon fixed the suture by looping it around the recoil ring then securing it to the abdominal wall.Review by medical affairs noted that for a mesh of this size there were a limited number of fixation points.Based on the size of the device (11cm x 14cm) it would be anticipated that a user may use at least twice as many fixation points to adequately secure the device to repair the hernia.Additionally, the limited fixation points would contribute to the contracture of the implant while in vivo.During evaluation there was an area of the recoil ring that was found to be separated.This was identified at an area in which the mesh was strongly contracted.The separation was located near the area that is welded to create a continuous loop.The weld itself was secure with no delaminating of the weld/ring interface.There was a suture placed very close to the location of the ring separation and this area was heavily contracted.It cannot be determined at this time if the material separation of the ring was present prior to removal or presented during the removal process itself.The contact did not report noting the ring to be separated.The surgeon who performed the procedure stated that he did not know if the recurrence was due to a defect of the prosthesis or was due to bad fixation of the prosthesis.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this lot of (b)(4) units released for distribution on 12/17/2010.At this time it appears that the problem was likely due to the manner in which the device was fixated, however the degree to which this may have been contributed to by the device itself cannot be determined.

• Brand Name: MESH - COMPOSIX KUGEL
• Type of Device: 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6383424
• MDR Text Key: 69255140
• Report Number: 1213643-2017-00155
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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: 12/30/2015
• Device Catalogue Number: 0010205
• Device Lot Number: HUUL0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 92