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

Catalog Number 0010206

Device Problems Defective Device (2588); Folded (2630); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Disability (2371); Obstruction/Occlusion (2422); Bowel Perforation (2668)

Event Date 08/24/2013

Event Type  Injury  

Manufacturer Narrative

To date no medical records have been provided.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.The information provided alleges the patient experienced adhesions, adhesions are listed as a known adverse reaction in the instructions-for-use.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to the patient's post op complications.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: (b)(6)2012 - the patient underwent an exploratory laparotomy for multiple ventral hernias.A composix kugel mesh was used to repair the hernia.(b)(6)2013 - the patient presented to the hospital with complaints of abdominal pain.The patient underwent a laparoscopic appendectomy and exposure laparotomy with small bowel resection and anastomosis.During the procedures, allegedly the patient's surgeon found that a portion of the small bowel was densely adhered to the mesh in the pelvis and that a portion of the mesh was partially exposed on the rough side and was adhering to the small bowel causing a likely low-grade erosion.The doctor noted that the mesh was not completely flat and a lower portion of the mesh was folded backward.The surgeon fixed the mesh placement as best as was possible.The attorney alleges the patient experienced pain, additional surgical procedure, erosion, adhesion and disability.

Manufacturer Narrative

To date no medical records have been provided.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.The information provided alleges the patient experienced adhesions, adhesions are listed as a known adverse reaction in the instructions-for-use.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to the patient's post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.Addendum: h11: this supplemental mdr is submitted to document additional information provided: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records provided, this is a patient with a complex medical/surgical history significant for obesity and multiple abdominal surgeries including previous hernia repair with mesh.Per the implant operative report, the surgeon "tacked the mesh in 4 places" per the instructions-for-use supplied with the device, "davol fixation devices and/or nonabsorbable monofilament sutures are recommended to properly secure the prosthesis.If other fixation devices are used, they must be indicated for use in hernia repair.Care should be taken to ensure that the patch is adequately fixated to the abdominal wall.If necessary additional fasteners and/or sutures should be used.Note: section a through f - the information provided by bd 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 bd.Not returned.

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent an exploratory laparotomy for multiple ventral hernias.A composix kugel mesh was used to repair the hernia.(b)(6) 2013 - the patient presented to the hospital with complaints of abdominal pain.The patient underwent a laparoscopic appendectomy and exposure laparotomy with small bowel resection and anastomosis.During the procedures, allegedly the patients surgeon found that a portion of the small bowl was densely adhered to the mesh in the pelvis and that a portion of the mesh was partially exposed on the rough side and was adhering to the small bowel causing a likely low-grade erosion.The doctor noted that the mesh was not completely flat and a lower portion of the mesh was folded backward.The surgeon fixed the mesh placement as best as was possible.The attorney alleges the patient experienced pain, additional surgical procedure, erosion, adhesion and disability.Addendum per additional information provided: (b)(6) 2012 - the patient was diagnosed with multiple ventral hernias and scheduled for exploratory laparotomy with implant of composix kugel patch.Per the operative report details, "the largest hernia was at the apex which was 8 cm and then there was a 5 cm hernia.There was a palpable shelf like piece of mesh (no product identifiers provided) in the pfannenstiel incision.We made no effort to go down to that area¿ ¿we lifted up the edges of the defect and took the composix mesh (composix kugel patch), soaked it in antibiotic saline and placed it on top of the omentum.We actually closed the defect and omentum." he then tacked the mesh in 4 places with prolene and protack.(b)(6) 2013 - the patient experienced abdominal pain and underwent laparoscopic appendectomy with small bowel resection.As per the op notes, appendectomy was performed and the ¿extensive adhesions noted in the anterior abdominal wall¿ the mesh came quite a bit over onto the left side of the abdomen¿ there was 1 knuckle of small bowel that was basically coming up to the anterior abdominal wall and stuck to the mesh¿ the mesh was not completely flat, as the lower portion of the mesh was actually folded backward, exposing the rough surface of the mesh, which the small bowel was adherent to¿¿ and tried to free this off the mesh, but it was densely adherent; small hole in the small intestine and erosion of the mesh to the small bowel had been noted.It was noted again that ¿the patient had very large pieces of mesh¿ i tried to avoid any sort of spillage whatsoever to try to avoid any sort of infection of this mesh, but, again, this is of course a concern that could develop, but, again, to remove the entire mesh on this patient at this point was not deemed indicated¿ to close this and prevent that mesh from basically folding back on itself, i incorporated part of the mesh in this closure so that way it would not again fold over on itself.¿ attorney alleges that the patient experienced adhesions, bowel obstruction, bowel perforation, mesh migration, mesh shrinkage, pain and emotional injuries.

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6844778
• MDR Text Key: 84966713
• Report Number: 1213643-2017-00563
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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: 07/28/2016
• Device Catalogue Number: 0010206
• Device Lot Number: HUVG0312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 75 KG