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

Catalog Number 0010208

Device Problems Defective Device (2588); Folded (2630); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)

Event Date 01/28/2013

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.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: patient underwent hernia repair surgical procedures, and during the course thereof the hernia repair product was implanted.The attorney alleges the patient experienced pain and suffering, injury and was seriously and permanently injured.

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 provided indicate the patient experienced adhesions, abscess, infection and fistula.The medical records do no specify which of the implanted mesh devices may have caused or contributed to the patient's symptoms.The medical records provided did not include any operative details for the two implant procedures in 2004 and 2012, therefore, the anatomical location of the meshes implanted is unknown at this time.Although there is unclear which mesh may have caused or contributed to the patient's symptoms experienced, adhesions and fistula are listed as known possible adverse reactions in the instructions-for-use.In regards to infection the warning section of the instructions-for-use 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." with the current information available, no definitive conclusion can be made at this time.If additional event and/or evaluation information is obtained, this report will be updated.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: (b)(6) 2004 - the patient underwent implant of a bard composix kugel hernia mesh and a non-bard davol mesh.No operative details were provided for this procedure.On (b)(6) 2012 - the patient underwent an incision and drainage of an abdominal wall abscess.No operative details were provided for this procedure.On (b)(6) 2013 - the patient was diagnosed with abdominal wall abscess, infected prosthetic mesh of the abdominal wall.The patient underwent an incision and drainage of abdominal wall abscess with debridement of abdominal wall, removal of infected prosthetic mesh, small bowel resection with primary anastomosis, repair of abdominal wall hernia with implant of a non bard davol "vicryl" mesh.Per operative details "at the side where the abscess pocket was appreciated the mesh had folded on itself anteriorly and there appeared to be small bowel loops adherent to the mesh and there was evidence of an enterocutaneous fistula.On exploration there was bilious discoloration of the mesh material.At this point the mesh was dissected out from the abd wall removing it completely." on (b)(6) 2013 - the patient was admitted to the hospital with septic shock.She had undergone repair of a large ventral hernia in the weeks preceding her admission.The patient was placed on broad spectrum antibiotics.A work-up found (b)(6) growing from her abdominal drainage (drains were still in place from surgery).The patient's sepsis resolved during her course.The patient worked with pt/ot and grew stronger during her stay.

Event Description

The following was reported to davol by the patient's attorney: ni/ni/ni -patient underwent hernia repair surgical procedures, and during the course thereof the hernia repair product was implanted.The attorney alleges the patient experienced pain and suffering, injury and was seriously and permanently injured.Addendum #1 per medical records: the following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2004 - the patient underwent implant of a bard composix kugel hernia mesh and a non-bard davol mesh.No operative details were provided for this procedure.(b)(6) 2012 - the patient underwent an incision and drainage of an abdominal wall abscess.No operative details were provided for this procedure.(b)(6) 2013 - the patient was diagnosed with abdominal wall abscess, infected prosthetic mesh of the abdominal wall.The patient underwent an incision and drainage of abdominal wall abscess with debridement of abdominal wall, removal of infected prosthetic mesh, small bowel resection with primary anastomosis, repair of abdominal wall hernia with implant of a non bard davol "vicryl" mesh.Per operative details "at the side where the abscess pocket was appreciated the mesh had folded on itself anteriorly and there appeared to be small bowel loops adherent to the mesh and there was evidence of an enterocutaneous fistula.On exploration there was bilious discoloration of the mesh material.At this point the mesh was dissected out from the abd wall removing it completely." (b)(6) 2013 - (b)(6) 2013 - the patient was admitted to the hospital with septic shock.She had undergone repair of a large ventral hernia in the weeks preceding her admission.The patient was placed on broad spectrum antibiotics.A work-up found mrsa growing from her abdominal drainage (drains were still in place from surgery.) the patient's sepsis resolved during her course.The patient worked with pt/ot and grew stronger during her stay.Addendum #2 per medical records: (b)(6) 2013 - the patient was diagnosed with a recurrent incisional ventral hernia repair with implant of a bard/davol phasix mesh, explant of the non bard/davol ¿vicryl¿ mesh, bilat myocutaneous flaps utilizing separation components procedure, small bowel resection and extensive lysis of adhesions.Per the operative report details, ¿we then were able to close the midline with looped pds and then place a 25 x 30 cm phasix mesh.¿ (b)(6) 2013-(b)(6) 2013 - the patient was found hypotensive and was transferred to another hospital for septic shock management.(b)(6) 2014- (b)(6) 2014 - the patient was hospitalized for a left carotid subclavian bypass.

Manufacturer Narrative

Addendum based on additional information provided by patients attorney which included additional medical records documenting recurrent incisional ventral hernia in (b)(6) 2013 with implant of a "bard/davol phasix mesh and explant of a non-bard/davol "vicryl" mesh".The new information presents after the explant of the bard/davol comosix kugel hernia patch in january 2013.This emdr represents the bard/davol composix kugel hernia patch (device #1).An additional emdr was submitted to represent the bard/davol phasix mesh (device #2).Should additional information be provided a supplemental emdr will be submitted.Note: section a through f - 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.

• 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: 5679148
• MDR Text Key: 45904592
• Report Number: 1213643-2016-00233
• 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: 10/23/2018

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: 06/30/2009
• Device Catalogue Number: 0010208
• Device Lot Number: 43FOD336
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; 10/17/2018
• Supplement Dates FDA Received: 03/08/2017; 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0526-06
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR