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

Catalog Number 0112670

Device Problems Folded (2630); Extrusion (2934); Material Deformation (2976)

Patient Problems Adhesion(s) (1695); Erosion (1750); Seroma (2069)

Event Date 11/15/2016

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 indicate the patient experienced mesh extrusion, folded mesh, adhesions, erosion and a seroma post explant procedure performed in (b)(6) 2016. Extrusion, adhesions and seroma are all listed as known possible adverse reaction in the instructions-for-use. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. Based on the information provided, it can not be determined whether the bard mesh may have caused or contributed to the problems experienced post implant due to the patient's history of previous abdominal/pelvic procedures and the additional non-bard davol mesh implanted. 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 medical records provided to davol by the patient's attorney: (b)(6) 2014 - the patient was diagnosed with vaginal vault prolapse, grade ii lateral recurrent cystocele and stress urinary incontinence. The patient underwent a robotic sacrocolpopexy with implant of a bard flat mesh, bilateral culdoplasty and implant of a non-bard davol retropubic midurethral sling followed by cystoscopy. Of note exam of the interior of the abdomen revealed adhesions from her prior surgery. On (b)(6) 2016 - the patient was diagnosed with extrusion of vaginal mesh and underwent a partial excision of the "sacrocolpopexy mesh" (bard flat mesh). Per the operative details "the mesh was noted to contracted and it had a fold. " the mesh was then grasped and excised until the exposed tissue was no longer visible. On (b)(6) 2016 - the patient was diagnosed with exposure of "sacrocolpopexy" vaginal mesh and underwent an excision of "approx. 2cm segment of the exposed vaginal mesh from the left apex. " on (b)(6) 2016 - the patient was diagnosed with exposure of the vaginal mesh from abdominal sacrocolpopexy into vagina. The patient underwent open excision of mesh, open uterosacral ligament suspension and cystoscopy. Per the operative details "the vaginal portion of the mesh appeared to have eroded into the vagina. The mesh was excised, with removal of the entire vaginal component of mesh, but leaving some of the sacral limb in place. " furthermore it was noted that the mesh had to be separated from the mesentery of the sigmoid colon, and this was done without injury to the sigmoid colon. On (b)(6) 2016 - the patient underwent a ct guided seroma drainage with removal of "serous fluid. ".

• 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: 6560113
• MDR Text Key: 74936480
• Report Number: 1213643-2017-00299
• Device Sequence Number: 1
• Product Code: FTL
• 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
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/28/2018
• Device Catalogue Number: 0112670
• Device Lot Number: HUXH0140
• 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: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2013
• 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: 05/11/2017 Patient Sequence Number: 1