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

Catalog Number 0010202

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

Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Disability (2371)

Event Date 01/04/2015

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date medical records have not been provided.It is alleged the patient experienced pain, fistula, abscess, material deformation, ring break, additional surgery and explant.Fistula is listed as a known adverse event in the instructions-for-use.In regards to the allegation of a ring break, no sample was returned for evaluation, therefore the allegation of ring break can not be confirmed or determined at this time.With the currently available information, no definitive conclusion can be drawn.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The subject product is part of the composix kugel recall.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 - patient underwent surgery to repair a ventral hernia, with implant of a bard composix kugel hernia patch.On (b)(6) 2014 - patient developed severe abdominal pain.On (b)(6) 2015 - patient was admitted to the hospital.Doctors first performed an irrigation and debridement of an abdominal wall abscess.On (b)(6) 2015 - the patient underwent a subsequent surgery which included irrigation and debridement of subcutaneous tissue; explant of the bard composix kugel mesh; inlay of vicryl mesh and placement of wound vac.In the operative report, the surgeon noted that the mesh had retracted and folded on itself in the lateral aspect of the wound.In an addendum to the operative report, the surgeon confirmed that the ring of the mesh was fractured at the mid portion of the oval, where the ring was possibly welded.On (b)(6) 2015 - patient underwent picc line placement and two additional invasive surgical procedures in the days following the removal of the ck hernia patch, due in part to the formation of an enterocutaneous fistula.On (b)(6) 2015 - over the course of his recovery, patient was treated with a wound vac that was placed over a large abdominal opening that required routine cleaning and changing, and treatments to the edge of the opening to prevent closure.This process was painful and difficult for the patient, in addition to requiring extensive home health care and follow up doctor visits.It is alleged the patient experienced pain, fistula, abscess material deformation, ring break, fistula, disfigurement and explant.

Manufacturer Narrative

Addendum to the initial report.This supplemental emdr is being sent due to new attorney information.To date no medical records have been provided.Based on the new information provided, it is alleged the patient experienced pain, infection, abscess, ring break, ring weld break and explant.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.¿ in regards to the allegations of ring break and ring weld break, no sample has been returned for evaluation, therefore the allegation of ring break/ring weld break can not be confirmed and the cause for the alleged break can not be determined at this time.It was originally alleged that the patient underwent additional medical procedures after the excision of the bard composix kugel hernia mesh, however, the new legal claim provided does not reference any type of additional medical treatments following the explant of the mesh device.A manufacturing review was performed and found no anomalies during the manufacturing process of the device.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The subject product is part of the composix kugel recall.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent ventral hernia repair with implant of a bard composix kugel hernia mesh.On (b)(6) 2014 - the patient presented to the er with complaints of abdominal pain, bloating and chills; a cat scan was performed and a large collection of fluid identified in the abdominal wall.The patient was discharged for follow up as outpatient.On (b)(6) 2014 - due to increasing pain the patient returned to the er and was transferred to another hospital due to the complexity of the abscess.The patient was evaluated by an infectious disease specialist who noted that the infection was likely due to the mesh and would require removal of the composix kugel.On (b)(6) 2015 - the patient underwent an explant surgery where the surgeon noted that the mesh had retracted and folded on itself in the lateral aspect of the wound, and the ring of the mesh was fractured at the midportion of the oval, where the ring was welded.The attorney alleges the patient experienced pain, infection, abscess, ring break, ring weld break, disability and explant.

Event Description

Addendum based on additional information provided by patients attorney which included the medical records: (b)(6) 2004¿patient underwent a ventral hernia repair with implant of a bard/davol composix kugel hernia mesh (device 1).(b)(6) 2005¿patient presented with complaints of another hernia on the left upper quadrant at the previous site of his colostomy.On exam, ¿possible multiple ventral hernias.No evidence of recurrent hernia on the previous site repaired in the right lower quadrant¿.02/ni/2007--patient underwent large ventral hernia repair with a composix lap mesh (device 2) in the central midline area.(b)(6) 2014¿patient presented to the hospital er for the 2nd time with complaints of right lower quadrant abd pain.Ct scan performed showed a fluid collection which was deemed an abscess.(b)(6) 2015¿patient was diagnosed with an abd wall abscess and underwent an exploratory surgery with evacuation of the abd wall abscess followed by a wound vac placement.Per the operative report details, ¿the abscess cavity seemed to be forming around an old prolene blue stitch, which was easily removed.There was mesh at the site, which was palpated, and appeared very well incorporated into the tissue and did not appear to be infected or harboring an abscess underneath the mesh.(b)(6) 2015¿patient was diagnosed with abd wall infection, infected mesh (device 1) and underwent irrigation and debridement.The bard/davol composix kugel mesh (device #1) patch was explanted.Implant of a non bard/davol vicryl mesh and placement of a wound vac.Per the amendment operative report, ¿the patient had his kugel mesh removed, and upon inspection the ring involved with the kugel (composix kugel, device #1) mesh was fractured at the mid portion of the oval.The fracture site would have been over the area where the ring was possibly welded, the middle of the oval (long axis).(b)(6) 2015¿patient was diagnosed with an entero-atmospheric fistula and underwent wound exploration and debridement with vac removal.Per the operative details, ¿ct imaging obtained overnight due to the output from wound vac which was suggestive of a small bowel fistula as the base of the wound.Md suspected the mesh (composix kugel, device #1) had eroded into the small bowel.01/07 - 08/2015¿patient underwent an abs wall resection with placement of a fistula drainage system.Underwent wound exploration and wound manger placement due to two additional fistulas identified.

Manufacturer Narrative

No sample was returned for evaluation, therefore the allegation of ring break and being located at the site of the weld, as well as a potential cause of ring separated cannot be determined at this time.The subject product is part of the composix kugel recall.With the currently information, no definitive conclusion can be drawn as to the cause of the patient's post-op complications and if the device caused or contributed to the problem experienced.A manufacturing review was performed and found the product was manufacturing to specification.Information provided allege the patient experienced pain, fistula, abscess, material deformation, ring break, additional surgery and explant.Fistula is listed as a known adverse event in the instructions-for-use.Regarding 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.¿ this emdr represents the bard/davol composix kugel (device #1).The patient's attorney did not make any allegations regarding the ¿composix lap mesh¿ and review of records identifies no adverse outcome associated with the second implant used to treat the patient.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: 6299705
• MDR Text Key: 66446340
• Report Number: 1213643-2017-00069
• 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: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 0010202
• Device Lot Number: 43KND419
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• 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
• Patient Weight: 169