MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; PORCINE SURGICAL MESH

Catalog Number UNKAA105

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

Patient Problems Wound Dehiscence (1154); Hernia (2240); Disability (2371)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges past, present and future damages, pain and suffering, permanent injury, recurrence, disfigurement and surgical intervention, however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol xenmatrix ab (device #2).An additional emdr was submitted to represent the bard/davol ventralight st w/ echo mesh (device #1).Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the patient underwent a ventral umbilical hernia repair via laparoscopic robotic surgery on (b)(6) 2017, during which a bard/davol ventralight st mesh with ps echo ps positioning system was implanted.The mesh measured 15cm long by 10cm wide.The implanting surgeon's operating report indicated that the surgical procedure was performed without incident and with no complications.By (b)(6) 2018, the plaintiff had developed symptoms suggesting that an infection had developed in the surgical area, and underwent surgery on that date.In the operative findings, the surgeon stated the following: "on wound exploration, there was obvious infected mesh.His abdomen was prepped and draped sterilely, and a timeout was taken.I began by inserting a pean clamp at the open draining portion of the wound and opening the skin overlying it.As soon as i opened this and inspected, i could see visible and grossly infected mesh.I knew within the first five minutes of the operation that this mesh would have to be explanted as i had suspected." the infected mesh was removed during this procedure; however, two days later, on (b)(6) 2018 the plaintiff was taken back to surgery because of postoperative fascial dehiscence and evisceration.During this surgical procedure, the surgeon debrided some of the necrotic fascia "that had not held suture very well," in the area where he had performed the mesh explantation surgery two days earlier.The surgeon then used retention sutures, further stating: "i did not feel that putting mesh or bio mesh in an infected field would be prudent." however, a short time after this surgical procedure, the plaintiff had to return to the operating room, where it was discovered that "the fascial sutures had pulled through, necessitating a return trip to the operating room from the recovery room." in his operative report, the surgeon further explained: "the plaintiff dehisced and eviscerated again in the recovery room.The #1 pus sutures at the upper apex and lower apex of the wound were intact.All the sutures at the mid-portion had pulled through.They were intact and unbroken but had pulled his fascia.These were removed as well." to further deal with these postoperative complications, the surgeon utilized xen matrix ab bio mesh.This mesh was soaked with antibiotic solution and trimmed to the appropriate size and folded in half during its implantation.The plaintiff remained hospitalized until (b)(6) 2018.In his discharge summary, the surgeon stated: "i took him to the operating room on (b)(6) 2018 for local wound exploration and at a wound exploration exposed infected mesh was identified.This was not surprising." in his final diagnosis, the surgeon stated: "mesh infection," and further indicated that the necessity for the surgical procedure on (b)(6) 2018, was for the "excision of infected mesh." the plaintiff was sent home with a portable wound vac for an area about 3x4 inches in a jagged rectangle cut out of the plaintiff's abdomen.Around (b)(6) 2018 the plaintiff was informed that he was developing a ventral hernia again because the most recent repair that he had performed was also failing and pulling apart.The surgeon informed the plaintiff that he would need a skin graft and then another laparoscopic hernia repair.The plaintiff consulted another surgeon at another facility, who immediately discontinued the wound vac.The surgeon also performed a successful skin graft on (b)(6) 2018.Unfortunately, the plaintiff was left with and still has a very large ventral hernia that will need further surgical repair.Attorney also alleges the patient sustained physical pain, mental anguish, impairment and disability.It is also alleged that the device was defective.

• Brand Name: XENMATRIX AB
• Type of Device: PORCINE 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: 9720027
• MDR Text Key: 188798793
• Report Number: 1213643-2020-01369
• Device Sequence Number: 1
• Product Code: PIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Disability
• Patient Age: 68