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

Catalog Number 0010302

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Insufficient Information (3190)

Patient Problems Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Hernia (2240); Disability (2371)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol ventralex may have caused or contributed to the reported event.The attorney alleges additional surgery to remove the infected mesh; however no details have been provided.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.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.¿ the cause of the patient postoperative complications cannot be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.Device not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2015:the patient underwent repair of an umbilical hernia.A bard/davol ventralex mesh, was implanted in patient during this repair.(b)(6) 2016:the patient underwent surgery to explant an infected umbilical hernia mesh.During the surgery, the ventralex mesh was removed in a single piece as it did not incorporate into patient's tissue and a repair was made to the umbilical hernia.The attorney alleges the ventralex mesh implanted in patient failed to reasonably perform as intended.The ventralex mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the ventralex mesh was initially implanted to treat.The patient was caused to suffer severe personal injuries, pain and suffering, and other damages.The patient has been injured, sustained ongoing, past and future severe and permanent pain, suffering, anxiety, depression, disability, impairment.Due to the alleged defective ventralex mesh.

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol ventralex may have caused or contributed to the reported event.The attorney alleges additional surgery to remove the infected mesh; however no details have been provided.Recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.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.¿ the cause of the patient postoperative complications cannot be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental emdr will be submitted.H11: this is an addendum to the initial emdr to document information provided via medical records.Based on medical records provided the patient was diagnosed with postoperative cellulitis of the umbilicus and developed serous drainage from umbilical incision indicated per md to likely be due to tobacco use, high dose steroid use, as well as poor hygiene.Additionally, the medical records state that during an exploratory surgery it was noted that the mesh did not appear to be well incorporated into the tissue and states that this is likely due to "is high-dose steroid use." the mesh was removed, "due to presence of visible mesh as well as concern for active infection, as well as chronic steroid use, decision made to remove mesh." based on the medical records provided, there is no indication of an issue with the bard mesh used to treat the patient hernia.Updated fields: a2, a4, b4, b5, b6, b7, g1, g2, g4, g7, h2, h6, h11.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.H3 other text : not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2015:the patient underwent repair of an umbilical hernia.A bard/davol ventralex mesh, was implanted in patient during this repair.(b)(6) 2016:the patient underwent surgery to explant an infected umbilical hernia mesh.During the surgery, the ventralex mesh was removed in a single piece as it did not incorporate into patient's tissue and a repair was made to the umbilical hernia.The attorney alleges the ventralex mesh implanted in patient failed to reasonably perform as intended.The ventralex mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the ventralex mesh was initially implanted to treat.The patient was caused to suffer severe personal injuries, pain and suffering, and other damages.The patient has been injured, sustained ongoing, past and future severe and permanent pain, suffering, anxiety, depression, disability, impairment.Due to the alleged defective ventralex mesh.Addendum per medical records provided by the patient's attorney: (b)(6) 2015 the patient underwent implant of the bard/davol ventralex hernia patch.Per implant operative dictation: "a piece of bard ventralex hernia patch mesh chosen.Mesh was laid underneath fascia and tacked to overlying fascia with four separate 0 prolene sutures.Satisfactorily covered hernia defect and laid flat satisfactorily within hernia defect.After tail of hernia patch was cut fascia overlying mesh closed with a running number one pds suture.(b)(6) 2015, (b)(6) 2015, (b)(6) 2016, and (b)(6) 2016, post-op visits the patient was evaluated for a non-healing wound.The patient developed swollen, tender area on the umbilicus.Evaluation finds erythema surrounding umbilicus, no firm ness or fluid collections.Diagnosis; cellulitis of the umbilicus.Patient developed serous drainage from umbilical incision indicated per md to likely be due to tobacco use, high dose steroid use, as well as poor hygiene.(b)(6) 2016 the patient underwent surgical wound exploration with explant of the ventralex mesh.Operative details note: "mesh did not appear to be incorporated into tissue at all, likely from his high-dose steroid use.Due to presence of visible mesh as well as concern for active infection, as well as chronic steroid use, decision made to remove mesh.Mesh was easily removed after cutting several of the fascial sutures which were intact.Mesh removed in a single piece.Mesh not incorporated into any surrounding tissues at all.".

• Brand Name: VENTRALEX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8348243
• MDR Text Key: 136475885
• Report Number: 1213643-2019-00934
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (y/n): N
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 0010302
• Device Lot Number: HUZC1881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 85