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

Catalog Number 0010206

Device Problems Break (1069); Defective Device (2588); Folded (2630); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)

Event Date 05/15/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided it was alleged the patient experienced adhesions of mesh, alleged folded mesh and ring break.Adhesions are listed as a known possible adverse reaction in the instructions-for-use.In regards to the allegation of ring break, the device was not returned for evaluation therefore the allegation of ring break can not be confirmed and the reason for the ring break can not be determined.The patient's medical history between the date of implant in (b)(6) 2004 and the date of explant in 2015 is unknown at this time.Without a lot number a review of the manufacturing records could not be conducted.With the currently available information, no conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up 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.Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent implant of the bard composix kugel mesh patch to treat a ventral hernia.On (b)(6) 2015 - the patient was admitted to the hospital for emergency surgery to remove the composix kugel mesh patch and repair a recurrent incarcerated ventral hernia.The surgeon removing the mesh patch noted " a lot of adhesions stuck to the mesh" and subsequently performed extensive lysis of the adhesions.The surgeon also noted that there were points where the mesh had "curled up onto itself and folded backwards causing the bowel to be stuck to the polypropylene part of the mesh." the surgeon identified the composix kugel mesh patch as the source of the patient's bowel injuries and determined that there was no way to unfold the mesh.Upon inspection of the mesh, the surgeon found that "the polyester ring holding the mesh flat had broken in multiple places." the attorney alleges the patient has experienced significant mental and physical pain and suffering, sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, recurrence, adhesions and curled/folded mesh.

Event Description

Addendum to the initial emdr to document additional information and medical records provided by the patient's attorney.(b)(6) 2004: the patient was diagnosed with complex recurrent incisional hernia times five and underwent repair with implant of a bard/davol composix kugel hernia patch.(b)(6) 2015: the patient was diagnosed with recurrent incarcerated ventral incisional hernia, extensive intraabdominal adhesions, peritoneal foreign body and underwent a reduction and repair of incarcerated ventral recurrent hernia using a non bard/davol "prolene" (ethicon) mesh with component separation, extensive lysis of adhesions and removal of the bard/davol composix kugel hernia mesh.Per the operative report details, "inspecting the mesh there was indeed a bard composix kugel mesh.There were some points where the mesh had curled up onto itself and folded backwards causing the bowel to be stuck to the polypropylene part of the mesh.These were the source of all the deseasonalized bowel injuries that had occurred.There was no way to unfold the mesh.I tried to cut it out, but noted that in doing so and inspecting the mesh i found that he polyester ring holding the mesh flat had broken in multiple places.The mesh had a history of being recalled for the broken polyester ring causing bowel perforation i decided that this mesh definitely needed to be removed completely." the attorney alleges the patient has experienced significant mental and physical pain and suffering, sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, recurrence, adhesions and curled/folded mesh.

Manufacturer Narrative

Addendum to the previous information based on receipt of medical records.Based on the provided medical records, 10 years post implant of the composix kugel mesh to repair a hernia, the patient developed and was treated for a hernia recurrence.During the hernia recurrence repair procedure it was noted that there was material deformation and adhesions related to the composix kugel.In addition, it was noted that the surgeon observed the mesh ring was in a broken state.No samples was proved for evaluation, therefore, the mode and cause of the observed broken ring cannot be determined, however, this lot of composix kugel was subject to a previous recall.Regarding recurrence and adhesions, both are known inherent risk of surgery and is listed in the instructions-for-use a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.

• 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
• MDR Report Key: 6519560
• MDR Text Key: 73620922
• Report Number: 1213643-2017-00272
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

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: 05/28/2008
• Device Catalogue Number: 0010206
• Device Lot Number: 43END417
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0524-06
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 68 YR
• Patient Weight: 96