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

Catalog Number 0112710

Device Problems Defective Device (2588); Torn Material (3024); Material Split, Cut or Torn (4008)

Patient Problems Adhesion(s) (1695); Nerve Damage (1979); Disability (2371)

Event Date 03/18/2015

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 no medical records have been provided.Without a lot number a review of the manufacturing records could not be conducted.Based on the information provided it is unclear what is meant when the surgeon alleged "a nerve was stuck to the mesh." 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: on (b)(6) 2014, the patient underwent implant of a bard mesh pre-shaped with keyhole to treat a left inguinal hernia.Allegedly the patient began experiencing excruciating left groin pain several months after the implantation.On (b)(6) 2015, the patient underwent excision of the bard mesh.Allegedly the surgeon noted that "a nerve stuck to the mesh." the surgeon attempted to spare the nerve.However, "on mobilizing the nerve off the mesh, two things happened: the mesh was completely torn and the nerve was torn as well." the surgeon then determined that the mesh had to be completely removed.The attorney alleges the patient experienced left groin pain, additional surgery, nerve damage, torn material, explant, adhesions and disability.

Event Description

Addendum to the initial emdr to document additional information and medical records provided by the patient's attorney.On (b)(6) 2014 the patient was diagnosed with a left indirect inguinal hernia with two cord lipomas, nerves lysed and underwent a left inguinal hernia repair with implant of a bard/davol pre-shaped mesh (device #1).Per the operative report details, "in the anteromedial position there were noted to be two cord lipomas.These were dissected back to the internal ring and amputated.There was no hernia sac.The ilioinguinal and iliohypogastric nerves were then identified, isolated, more proximally and then transected as they went into the musculature.The hernia was then repaired with a piece of prolene mesh (bard/davol pre-shaped, device #1).This was tacked medially at the pubic tubercle, inferiorly at the iliopubic tract, and superiorly at the conjoint tendon.Laterally, a keyhole incision was fashioned and wrapped around the spermatic cord at the internal ring and secured to itself".On (b)(6) 2015 the patient experienced shooting pain again in his left groin which was inhibiting him from normal activities and was diagnosed with a possible recurrent left inguinal hernia, however, was found to have a nerve along the medical aspect of the mesh stuck to the mesh (bard/davol pre-shaped mesh, device #1) and the mesh (device #1) was removed and replaced with another bard/davol pre-shaped mesh (device #2).Per the operative report details, "medially, at the superior medial aspect of the mesh (device #1), there was noted to be a nerve stuck to the mesh.At this level, the nerve was attempted to be spared.However, on mobilizing the nerve off of the mesh (device #1), two things happened, 1; the mesh was completely torn and 2;the nerve was torn as well.For this reason, the nerve was isolated back proximal to the mesh (device #1), but in doing so, the mesh had to be essentially be removed.The nerve was then mobilized more proximally and transected.The mesh (device #1) was removed".The attorney alleges the patient experienced left groin pain, additional surgery, nerve damage, torn material, explant, adhesions and disability.

Manufacturer Narrative

Addendum to the previous information based on receipt of medical records.Based on the medical records provided it appears that the patient developed an adhesion between the bard/davol pre-shaped mesh (device 1) and the nerve.Adhesions are known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Based on the explant operative report, original allegation of torn material was the result of the pre-shaped mesh (device 1) explant, and not a device issue.Based on the information provided we are unable to determine to what extent, if any the bard device may have caused and/or contributed to the events.This mdr represent the bard/davol pre-shaped mesh (device 1).No allegation has been made related to the bard/davol pre-shaped mesh (device 2) should additional information be provided a supplemental emdr will be submitted.

• Brand Name: BARD MESH PRE-SHAPED
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6509153
• MDR Text Key: 73331032
• Report Number: 1213643-2017-00259
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 0112710
• Device Lot Number: HUYF1805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 84