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

Catalog Number 0010101

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

Patient Problems Unspecified Infection (1930); Pain (1994); Sepsis (2067)

Event Date 05/23/2005

Event Type  Injury  

Manufacturer Narrative

The medical records indicate the patient experienced a "recurrent ventral incisional hernia." recurrence is listed as a possible adverse reaction in the instructions-for-use.While the medical records indicate the patient experienced infection/sepsis, it appears based on the information provided that the infection was related to the composix kugel mesh and not to the kugel patch.With the current information available at this time, no definitive conclusion can be made as to the extent that the kugel mesh may have caused or contributed to the patient's symptoms experienced after implant.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the kugel mesh implanted in 2004, a second file had already been opened to address the composix kugel mesh implanted in 2005.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 is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2004 - the patient underwent repair of a ventral incisional hernia with implant of a kugel mesh.No operative details were provided for this procedure.On (b)(6) 2005 - the patient underwent repair of a recurrent ventral incisional hernia with implant of a composix kugel hernia mesh.No operative details were provided for this procedure.On (b)(6) 2012 - the patient was diagnosed with abdominal pain, sepsis and lymphadenopathy.The patient underwent an exploratory laparotomy, small bowel resection, lysis of adhesions and partial removal of an infected composix kugel mesh and explant of the bard kugel patch.The operative details indicated "on ct scan, there was a fluid collection deep to the mesh and the mesh was incised and purulent drainage was immediately found." in addition the operative details note that when encountering the mesh "this was a composix type mesh with an underlying prolene layer and then a gore layer deep to that.On one side of the mesh it had become separated from the abdominal wall and was actually extending down into the abdomen cavity and on the prolene side of the mesh, small bowel had become adherent to this and erosion and a fistula had formed." per notes all of the "gore" material was removed and most of the prolene mesh was removed as well.Based on a legal affidavit signed by the physician on (b)(6) 2015, "the patient's mesh was folded over and small bowel was adherent to mesh.Impossible to tell from this whether mesh was prolene.Defective with certainty.Fistula was due to contact of small bowel to unprotected prolene mesh.".

Manufacturer Narrative

This is an addendum to the initial mdr to document additional information and medical records provided by the patients attorney.Additional information includes explant date, (b)(6) 2005, of the bard/davol composix kugel hernia patch (device #1).As previously reported, the medical records indicate the patient experienced a "recurrent ventral incisional hernia".Recurrence is listed as a possible adverse reaction in the instructions-for-use.While the medical records indicate the patient experienced infection/sepsis, the infection presented after the kugel patch (device #1) was explanted.With the current information available at this time, no definitive conclusion can be made as to the extent that device #1 may have caused or contributed to the patient's symptoms experienced after implant.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the bard/davol composix kugel hernia patch (device #1) implanted in 2004.A separate file has been opened to address the bard/davol composix kugel (device #2) implanted in 2005.Should additional information be provided a supplemental emdr will be submitted.

Event Description

Addendum based on additional information and medical records provided by patients attorney: (b)(6) 2004 patient was diagnosed with a ventral incisional hernia and underwent repair with implant of a bard/davol kugel hernia patch (#1).(b)(6) 2005-patient was diagnosed with recurrent incisional hernia and underwent a laparoscopy with conversion to an open repair of recurrent incisional hernia which included removal of the bard/davol ¿kugel¿ mesh (#1) and implant of the bard/davol composix kugel hernia patch (#2).(b)(6) 2012-patient was diagnosed with abdominal pain, sepsis, lymphadenopathy and underwent exploratory laparotomy, small bowel resection, lysis of adhesions, a partial removal of an infected bard/davol composix kugel hernia mesh (#2).The operative details indicated "on ct scan, there was a fluid collection deep to the mesh and the mesh was incised and purulent drainage was immediately found." in addition the operative details note that when encountering the mesh "this was a composix type mesh with an underlying prolene layer and then a gore layer deep to that.On one side of the mesh it had become separated from the abdominal wall and was actually extending down into the abdomen cavity and on the prolene side of the mesh, small bowel had become adherent to this and erosion and a fistula had formed." per notes all of the "gore" material was removed and most of the prolene mesh was removed as well.(b)(6) 2012¿patient was diagnosed with enterocutaneous fistula from 2 segments of small bowel and underwent exploratory laparotomy, small bowel resection x2, lysis of adhesions with another small piece of the bard/davol ck mesh (#2) removed.Per the attorney info page from surgeon (legal affidavit signed by the physician on (b)(6) 2015), "mesh was folded over and small bowel was adherent to prolene mesh (#2ck).Impossible to tell from this whether most was prolene (#2ck).Defective with certainty.Fistula was due to contact of small bowel to unprotected prolene mesh (#2 ck).".

• Brand Name: KUGEL PATCH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6390876
• MDR Text Key: 69489041
• Report Number: 1213643-2017-00168
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K963141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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: 02/28/2009
• Device Catalogue Number: 0010101
• Device Lot Number: 43BOD216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR