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

Model Number 0112670

Device Problems Material Disintegration (1177); Extrusion (2934); Material Deformation (2976)

Patient Problems Erosion (1750); Pain (1994); Injury (2348); Disability (2371); Prolapse (2475)

Event Date 09/28/1999

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The medical records provided included the patient's implant operative report/tracking log for the bard flat mesh only. The attorney alleges the patient experienced shrinkage, disintegration and/or degradation of mesh, however, no medical records have been provided to support these allegations. The patient's medical course between the original implant of the bard flat mesh in 1999 and the implant of non-bard davol mesh with excision of mesh in the (b)(6) 2014 procedure is unknown. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any 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 is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 1999 - the patient was diagnosed with uterovaginal prolapse and genuine stress incontinence. The patient underwent a total abdominal hysterectomy, abdominal sacrocolpopexy with implant of a bard flat mesh, burch procedure, paravaginal repair, abdominal cystocele repair, placement of a suprapubic catheter, posterior repair and a perineoplasty. In 2003 - the attorney alleges the patient experienced severe and debilitating medical injuries, such as shrinkage, disintegration and/or degradation of the mesh which required excision and/or repair. On v 2014 - the attorney alleges the patient underwent implant of a non-bard davol "upsylon y mesh" as well as excision of mesh. Per the attorney's legal claim the patient experienced severe and debilitating medical injuries, such as the shrinkage, disintegration and/or degradation of the mesh product inside her body which required excision and/or repair on or about 2003 and (b)(6) 2014.

Manufacturer Narrative

Addendum to the initial report. This supplemental emdr is being sent due to additional information received. It was originally reported that the patient underwent a partial excision of mesh in (b)(6) 2014. The medical records now provided indicate that the patient had a partial explant sometime in 2003, no operative details were provided for this procedure. The medical records further indicate that in the (b)(6) 2014 procedure a piece of mesh from the prior sacrocolpopexy in 1999 was identified and left in intact. It was alleged the patient experienced extrusion of mesh, extrusion is listed as a known possible adverse reaction in the instructions-for-use. It was also alleged that the patient experienced infection, however the medical records do not mention any type of infection experienced by the patient. In regards to 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. ¿ a manufacturing review was performed which found no anomalies during the manufacturing process of the device. With the current information, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 1999 - the patient was diagnosed with procidentia, genuine stress incontinence and rectocele. The patient underwent a total abdominal hysterectomy, abdominal sacrocolpopexy with implant of a bard flat mesh, paravaginal repair, burch procedure, posterior repair, cystoscopy and suprapubic catheter placement. On (b)(6) 1999 - the patient was diagnosed with mesh erosion and recurrent urinary tract infection. Exam under anesthesia revealed approximately a 2 cm circular area where the mesh had eroded through the vaginal apex. The patient underwent a revision procedure which included "vicryl used to reapproximate the vaginal apex over the mesh" to cover the "2 cm circular area. " on (b)(6) 2002 - the patient underwent an abdominal sacrocolpopexy with "fascial graft. " no operative details were provided. On (b)(6) 2003 - the patient had mesh erosion and had it excised at the cervix. No operative details were provided. On (b)(6) 2014 - the patient was diagnosed with recurrent pelvic organ prolapse, stress urinary incontinence and urethral hypermobility. The patient underwent an abdominal sacrocolpopexy with implant of a non-bard davol mesh, lysis of adhesions, rectocele repair and implant of a non-bard davol suburethral sling followed by cystoscopy. The operative details provided indicated "an old piece of mesh from the prior sacrocolpopexy in 1999 was identified and left intact. " on (b)(6) 2014 - (b)(6) 2015 - the patient had multiple md office exams with complaints of chronic pelvic pain, tailbone pain, and dyspareunia. The patient was diagnosed with a small area of vaginal "mesh erosion" and was treated conservatively with a vaginal estrogen cream. The patient also underwent multiple physical therapy sessions, botox injections and underwent trigger point injections for the chronic pelvic and tailbone pain. The physician indicated in the exam notes "foreign body, possibly embedded mesh and unspecified bunched up mesh at the midline which was felt, however, not painful. " on (b)(6) 2016 - the patient was diagnosed with a right peritoneal cyst, right ovarian cyst and extensive intraabdominal and pelvic adhesions and underwent laparoscopic right salpingo oophorectomy, excision of peritoneal cyst and laparoscopic right ureterolysis. Operative findings indicated that "the vagina had no palpable abnormalities or evidence of any mesh erosion. " on (b)(6) 2017 - the patient complained of right hip pain and was diagnosed with iliopectineal bursitis and underwent steroid injections to help with pain and inflammation. The attorney's legal claim alleges the patient experienced pain, erosion, extrusion, infection, bleeding, recurrence, dyspareunia, vaginal scarring, urinary problems and bowel problems.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6487234
• MDR Text Key: 72653138
• Report Number: 1213643-2017-00235
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)040528(10)43EJD327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/28/2004
• Device Model Number: 0112670
• Device Catalogue Number: 0112670
• Device Lot Number: 43EJD327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/1999
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/12/2017 Patient Sequence Number: 1