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

Catalog Number 0010202

Device Problems Defective Device (2588); Folded (2630); Detachment of Device or Device Component (2907); Material Deformation (2976); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Sepsis (2067); Injury (2348); Disability (2371)

Event Date 11/14/2012

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.The patient's attorney did not allege a specific device failure and medical records have not been provided.Without a lot number a review of the manufacturing records could not be conducted.Additionally, no product was returned for evaluation.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.

Event Description

The following was reported to davol by the patient's attorney: patient had hernia repair surgery, which included implantation of a hernia repair product.The attorney alleges the patient experienced "pain and suffering", disability and injury.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to provide additional information based on a medical record review.The medical records indicate the patient experienced sepsis/infection, erosion, fistula and adhesions.Fistula and adhesions are listed as known possible adverse reactions in the instructions-for-use.In regards to infection the warning section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ it was also reported in an affidavit signed by the patient's surgeon that the mesh was folded.With the current information available at this time, no definitive conclusion can be made as to the extent that the composix 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 composix kugel mesh (#2) implanted in 2005, a second file has been opened to address the kugel patch (#1) implanted in 2004.The subject product is part of the composix kugel recall.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (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.Medical records indicate the patient experienced sepsis/infection, erosion, fistula and adhesions.Fistula and adhesions are listed as known possible adverse reactions in the instructions-for-use.In regards to infection the warning section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ it was also reported in an affidavit signed by the patient's surgeon that the mesh was folded.Additional information regarding the bard/davol composix kugel (device #2) describes additional laparotomy with removal of another small piece of the bard/davol composix kugel (device #2); however, a sample was not returned for evaluation.Based on the limited information provided at this time, no conclusions can be made.The subject product is part of the composix kugel recall.Updated fields: patient identifier, event, explant date, mfr site, report source, date rec¿d by mfr, pma/510k and if follow-up, what type.Should additional information be provided a supplemental emdr will be submitted.This file represents the bard/davol composix kugel (device #2) implanted in 2005.A separate file was opened for the bard/davol composix kugel (device #1) implanted in 2004.

Event Description

Addendum based on additional information and medical records provided by patients attorney: on (b)(6) 2004: patient was diagnosed with a ventral incisional hernia and underwent repair with implant of a bard/davol kugel hernia patch (#1).On (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).On (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.On (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: 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: 5230607
• MDR Text Key: 31415357
• Report Number: 1213643-2015-00380
• 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,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: 02/28/2010
• Device Catalogue Number: 0010202
• Device Lot Number: 43BPD295
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/17/2015
• Supplement Dates Manufacturer Received: Not provided; 10/17/2018
• Supplement Dates FDA Received: 03/09/2017; 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0760-06
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 51 YR