MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE TEX VASCULAR GRAFT (NO LINE DESIGNATED); PROSTHESIS, VASCULAR GRAFT

Catalog Number VT04010LA

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Pain (1994); Discharge (2225)

Event Date 07/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.It should be noted that the gore-tex® vascular graft instructions for use states that gore-tex® vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.The ifu states: "do not use gore-tex® vascular grafts as a patch.If cut and used as a patch, gore-tex® vascular grafts may lack adequate transverse strength." the gore-tex® vascular graft ifu also states: ¿complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.¿.

Event Description

It was reported to gore that ¿on (b)(6) 2015, plaintiff presented to (b)(6) hospital and underwent an anterior and posterior vaginal repair, transvaginal bladder neck suspension and a stamey procedure with cystoscopy.The surgical procedure was performed by drs.(b)(6).¿ the complaint states that ¿during the procedure, a ¿straight graft 4x10 (vt04010la)¿, manufactured by defendant gore, was implanted during the repair of the abdomino-vaginal vesical neck.¿ the complaint alleges that ¿following the surgical procedure on (b)(6) 2015, [the patient] developed complaints including pelvic pain, lower back pain, discharge, fevers, sweating and urinary incontinence.¿ it was reported that ¿on or about (b)(6) 2016, the graft product and stamey suture became loose inside [the patient]¿s vagina.[the patient] was able to remove a portion of the graft product that had become loose.¿ the complaint states that ¿on or about (b)(6) 2016, [the patient] presented to dr.(b)(6), who performed an examination of the [the patient].Dr.(b)(6) determined that the graft product and stamey suture had fragmented and eroded into [the patient]¿s vaginal wall.¿ it was reported that ¿[the patient] unsuccessfully attempted a course of conservative treatment.On (b)(6) 2017, [the patient] underwent a total robotic hysterectomy, bilateral salpingoophorectomy, uterosacral ligament suspension, ablation of endometriosis and cystoscopy by a physician who specializes in obstetrics and gynecology and robotic surgery.¿ the complaint alleges that ¿as a result of her injuries resulting from the defective graft product, [the patient] was caused to suffer severe and permanent injuries and damages.¿ additional event specific information was not provided.

Manufacturer Narrative

H6: code 4316 is being used for: false claim.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: updated conclusion codes.H6: conclusion code 4316: appropriate term/code not available used for "withdrawn complaint" as this lawsuit was dismissed by the court and withdrawn by the claimant, it is being closed.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore-tex® vascular graft instructions for use states that gore-tex® vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.The ifu states: "do not use gore-tex® vascular grafts as a patch.If cut and used as a patch, gore-tex® vascular grafts may lack adequate transverse strength." the gore-tex® vascular graft ifu also states: ¿complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE TEX VASCULAR GRAFT (NO LINE DESIGNATED)
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8254967
• MDR Text Key: 133358341
• Report Number: 2017233-2019-00036
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VT04010LA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/14/2020; 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention