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

Catalog Number 0010105

Device Problems Material Disintegration (1177); Defective Device (2588); Material Deformation (2976)

Patient Problems Fistula (1862); Sepsis (2067); Bowel Perforation (2668)

Event Date 02/25/2013

Event Type  Injury  

Manufacturer Narrative

The patient's attorney has not provided medical records to asses the validity of the alleged problems related to the use of the device.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.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 by the patient's attorney: on (b)(6) 2005 - patient had the bard/davol composix kugel medium oval, 11cm x 14cm implanted in her abdomen.On (b)(6) 2013 - patient underwent surgery and the surgeon allegedly discovered the product "partially disintegrated and misshapen" in the patient's abdomen.The surgeon also discovered the product allegedly caused the patient serious injuries including but not limited to, abdominal pain, high fever, tenderness at the site where the product was inserted, unusual intestinal symptoms, intestinal fistulas, sepsis, and bowel perforations.The patient's attorney alleges that as a result of having the product implanted in her, the patient has experienced significant pain and suffering, sustained permanent injury, and has undergone medical treatment and procedures.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent due to a correction to the lot number provided for this device.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent due to a correction in the product identifiers previously reported.Product identifiers provided show that the patient was implanted with a kugel patch and not a composix kugel patch as was originally reported.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Event Description

As originally reported by the patient's attorney in 03/2016.(b)(6) 2005 - patient had the bard/davol composix kugel medium oval, 11cm x 14cm implanted in her abdomen.(b)(6) 2013 - patient underwent surgery and the surgeon allegedly discovered the product "partially disintegrated and misshapen" in the patient's abdomen.The surgeon also discovered the product allegedly caused the patient serious injuries including but not limited to, abdominal pain, high fever, tenderness at the site where the product was inserted, unusual intestinal symptoms, intestinal fistulas, sepsis, and bowel perforations.The patient's attorney alleges that as a result of having the product implanted in her, the patient has experienced significant pain and suffering, sustained permanent injury, and has undergone medical treatment and procedures.Addendum to the previous information based on medical records review: (b)(6) 2005 - the patient was diagnosed with abdominal incisional hernia and underwent incisional hernia repair with implant of a composix kugel hernia mesh.(b)(6) 2005 - the patient was diagnosed with cholelithiasis and cholecystitis and underwent laparoscopic cholecystectomy (b)(6) 2007 - the patient was diagnosed with a possible liver problem secondary to remicade use for crohns' disease and underwent a laparoscopy liver biopsy.At some point in 2008 the patient was diagnosed with gastric tuberculosis.(b)(6) 2012 - (b)(6) 2012 - the patient was diagnosed with crohn's with perforated terminal ileum and underwent an exploratory laparotomy, adhesiolysis, ileocecostomy with end ileostomy.During this time the patient developed post-operative intra-abdominal abscesses with a surgical site infection.The patient's midline wound was opened at bedside and daily wound dressings were performed.(b)(6) 2012 - the patient's wound became difficult to keep clean due to her ileostomy spilling into the wound.The patient was discharged home with healthcare.She returned to the hospital about 2 weeks later as she had developed increasing erythema and pain around the wound.Again, there were significant problems keeping the wound clean due to spillage from the ileostomy.(b)(6) 2012 - the patient presented to the hospital with worsening and pain, worsening breakdown of her skin around her stoma.The patient was unhappy with the care she was receiving at the wound clinic and left against medical advice.The patient then presented to the hospital er.(b)(6) 2013 - the patient was diagnosed with leak and malfunction of ileostomy due to crohn's disease, exposed infected ventral hernia mesh (ck), small bowel adhesions and underwent a take-down of ileostomy, resection of ileum bowel, lysis of adhesions, removal of the composix kugel mesh, right colectomy, implant of a non-bard davol "biodesign sugisis" graft and ileocolic anastomosis.The physician stated "i widely excised the fascia and the mesh that was present.I irrigated the mesh and resected 3 small pieces of it to submit to pathology for cultures, anaerobic and aerobic.There was no gross purulent drainage.I was able to get the mesh off of the smallbowel, but the small bowel was densely adhered and gnarly the last couple of feet; and therefore, i freed it up." further more the physician stated "all of the old mesh had been completely removed." (b)(6) 2013 - the patient was discharged home with wound vac and home healthcare.(b)(6) 2013- (b)(6) 2015 - the patient underwent multiple debridement procedures, excision of two non bard davol prolene sutures and aspiration of an abdominal wall seroma.

Manufacturer Narrative

Addendum to the previous information provided.This supplemental emdr is being sent due to additional information received from the patient's medical records and to correct the expiration date of the composix kugel device.Originally it was reported that the patient had a "partially disintergrated and misshapen" device and had experienced fistulas, sepsis and bowel perforation.Based on the medical records provided and the patient's surgical/medical history there is no indication of the mesh being disintergrated or misshapen and the allegation of fistulas and bowel perforation appear to be related to the patient's ongoing issues with crohns' disease.While the mesh was reported to be infected, the infection seems to be a related to the patient's crohns' disease.There is no indication of an adverse patient outcome directly related to the mesh.

• 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: 5513684
• MDR Text Key: 40776265
• Report Number: 1213643-2016-00109
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2018

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: 04/28/2003
• Device Catalogue Number: 0010105
• Device Lot Number: 43DLD151
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: 02/09/2018; 03/08/2018; 10/17/2018
• Supplement Dates FDA Received: 02/22/2018; 03/27/2018; 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability