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

Catalog Number 0112640

Device Problems Defective Device (2588); Material Deformation (2976); Material Protrusion/Extrusion (2979); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987); Disability (2371); Nervous System Injury (2689)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including organ perforation, permanent injury, erosion, mesh contraction, infection and subsequent surgical intervention.The instructions-for-use supplied with the device lists inflammation as a possible complication.In regard to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." no lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on or about (b)(6) 2011, the patient had surgery on the abdomen and a bard/davol flat mesh was installed, along with a non-bard/davol product and utilizing non-bard/davol suture clips to treat stress pelvic floor prolapse.The patient had the mesh removed on (b)(6) 2019.It is alleged that as a result of the pelvic mesh products, the patient has sustained permanent injury, and has experienced and will continue to experience significant mental and physical pain and suffering.It is also alleged that the injuries, conditions and complications suffered by the patient due to the pelvic mesh products include but are not limited to mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.It is alleged that the patient was hurt, injured, sustained injury to the nervous system which have caused great mental, physical and nervous pain and suffering and some permanent disability.It is also alleged that the device was defective.

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including organ perforation, permanent injury, erosion, mesh contraction, infection and subsequent surgical intervention.Addendum: h.11: this is an addendum to the initial emdr (mdr no.1213643-2020-11239) submitted.This supplemental emdr is being submitted to report the product and event details received in the medical records.Based on the information received, the patient experienced chronic pain and underwent explant of the mesh.As reported, there is no malfunction of the device with the information provided.A review of the manufacturing records was performed and found that the lot was manufactured to specification.There are no medical records provided beyond this time, therefore the patient¿s clinical course is unclear.The explanted mesh was not returned to the manufacturer for evaluation.Based on the medical records received, there is no way to determine whether the bard/davol flat mesh may have caused or contributed to the problems experienced.Summary will be updated if/when additional information is received.The instructions-for-use (ifu) supplied with the device lists inflammation and extrusion as possible complications.In regard to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental emdr will be submitted.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

Attorney alleges that on or about (b)(6) 2011, the patient had surgery on the abdomen and a bard/davol flat mesh was installed, along with a non-bard/davol product and utilizing non-bard/davol suture clips to treat stress pelvic floor prolapse.The patient had the mesh removed on (b)(6) 2019.It is alleged that as a result of the pelvic mesh products, the patient has sustained permanent injury, and has experienced and will continue to experience significant mental and physical pain and suffering.It is also alleged that the injuries, conditions and complications suffered by the patient due to the pelvic mesh products include but are not limited to mesh erosion, mesh exposure, mesh contraction, infection, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, pelvic floor damage, pelvic pain, and recurrent urinary incontinence.It is alleged that the patient was hurt, injured, sustained injury to the nervous system which have caused great mental, physical and nervous pain and suffering and some permanent disability.It is also alleged that the device was defective.Addendum: per information provided in the medical records: (b)(6) 2011 - a 48-year-old female, with a history of hysterectomy was diagnosed with residual ovarian syndrome with vault prolapse and was scheduled to undergo a robotic-assisted laparoscopic bilateral salpingo-oophorectomy procedure with colposuspension with implant of a prolene (bard flat mesh).Access to the pelvic cavity was obtained, the infundibulopelvic ligament was coagulated and excised.The anterior pelvic compartment was seen to prolapse into the entire bowl of the pelvis coalescing with the posterior cul-de-sac.Both adnexa were in their normal anatomical position except for some adhesion formation of the undersurface of the ovaries bilaterally to the lateral pelvic wall bilaterally.Both ovaries had clearly visible hemorrhagic cysts.Based on operative notes, ¿the posterior parietal peritoneum was dissected off the vaginal apex.The round ligaments and attached to the middle portion of the neovaginal apex using 0-vicryl on a pulley stitch with lapra-ty at both ends.Once both round ligaments were attached to the vaginal vault, the sandwiched mesh, consisting of bovine mesh on either side of a prolene (bard flat mesh) mesh was as placed in the midportion of the vaginal apex and attached with a o-vicryl suture with lapra-ty of both ends.The mesh was then secured to the round ligaments using o-vicryl in a running noninterlocking fashion incorporating the entire round ligament into the mesh which overlie the mesh in the form of a curtain over a rod.Once this was completed, from one end of the round ligament to the next, the mesh was then buried with the posterior parietal peritoneum sutured together with a 0-vicryl in a running noninterlocking fashion.¿ (b)(6) 2011 - pathology report specimen revealed corpus luteum of ovaries and fallopian tubes with hydatid cyst of morgagni.(b)(6) 2019 - the patient had a hospital visit with history of persistent pelvic pain for the past 6 months which was associated with the ¿surgical mesh¿; pap smear was negative for neoplasia.A pelvic ultrasound (b)(6) 2019) revealed no abnormal soft tissue or fluid collection.(b)(6) 2019 - patient had a follow-up visit for complaints of persistent pain at the right vaginal apex and was referred to another facility for further management.(b)(6) 2019 - the patient had a visit for evaluation of pain.Surgeon noted patient ¿has resultant chronic abdominal and pelvic pain and pressure¿; surgical removal via a combined laparoscopic and open approach was planned.(b)(6) 2021 - the patient had occasional exquisite pain in the middle of the pelvis which radiated to the bladder and vagina and was scheduled for diagnostic laparoscopy and mesh removal.As reported, the patient had occasional exquisite pain in the middle of the pelvis which radiated to the bladder and vagina and was scheduled for diagnostic laparoscopy and mesh removal on (b)(6) 2019.Per operative notes, ¿10 cm mesh (running) across adherent to bilateral round ligaments.The decision was made to remove the mesh via an open dissection.The peritoneum was accessed, ¿at this point the mesh was again identified and palpated and confirmed to be ~10 cm in width spanning the area from round ligament to round ligament.The mesh was undermined bluntly and incised at the midline and elevated off of the underlying vagina.With careful sharp and blunt dissection the mesh was dissected bilaterally off of the underlying vagina until all was excised bilaterally.At this time the peritoneum defect left was reapproximated with 2-0 running vicryl suture.¿ (b)(6) 2019 - pathology report of the explanted mesh revealed two fragments of roughened foreign material measuring 3.0 x 1.8 x 0.7 cm and 4.3 x 1.0 x 0.7 cm.(b)(6) 2019 - the patient had a follow-up visit for post-operative evaluation, had peri-incisional muscular pain and mild erythema.The patient reported that the tugging pain attributed to the mesh had resolved.(b)(6) 2019 to (b)(6) 2019 - the patient had multiple follow-up visits for surgical wound drainage, mild erythema and pelvic pain, and was prescribed pain medication and antibiotics.

• Brand Name: BARD FLAT MESH
• 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: 11023484
• MDR Text Key: 222016528
• Report Number: 1213643-2020-11239
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Catalogue Number: 0112640
• Device Lot Number: HUUG0089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2010
• 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): Life Threatening; Disability; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 56 KG