MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT; SURGISIS ES

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Therapeutic Response, Decreased (2271); Discomfort (2330); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant products - essure device and ethibond sutures on (b)(6) 2007; surgisis 7x10 on (b)(6) 2009.**this mdr is related to mdr 1835959-2013-02132.** the root cause, of the patient¿s current complaints, is inconclusive.The patient has a complicated history affected by three vaginal births, one abortion, chronic vaginitis, what appears to be a reaction to the ethibond sutures used in a 2007 surgery, and fistulas that were possibly present prior to the 2009 placement(s) of surgisis.

Event Description

The patient was reportedly implanted with a surgisis urethral sling on or about (b)(6) 2009, at (b)(6) to treat her stress urinary incontinence.The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced pain, injury, and has undergone corrective surgery.In (b)(6) 2009, at the (b)(6), the patient underwent surgery for vaginal graft erosion, infection, and possible rectovaginal fistula.Dr.(b)(6) excised what he called a vaginal graft (medical records did not indicate placement of a graft in the (b)(6) 2007 surgery), removed another suture from the 2007 surgery, and repaired rectovaginal fascia and vaginal epithelium.It is unclear if a graft was placed during this surgery and if so, what brand of graft was utilized.A colorectal surgeon was present for the surgery, for the suspected rectovaginal fistula, but no repair was performed.The patient was discharged to home the same day.In early (b)(6) 2009, the patient returned to dr.(b)(6) with complaints of sutures coming undone and a thread hanging from her vagina.This appeared to be protrusion of the graft (unclear which graft and when it was placed) through the incision line of the vaginal wall.On (b)(6) 2009, dr.(b)(6) excised the graft material and a surgisis 4x7 cm graft was placed anteriorly to the vaginal apex and cul-de-sac and underneath the cervix at the right and left fornix.Another suture was also removed from the vagina.After this procedure, the patient began experiencing discomfort in certain sitting positions, dull pain and cramping, vaginal pain and pain and bleeding with intercourse.The patient once again began to experience vaginal infections with discharge.On (b)(6) 2009, (b)(6) 2009, and (b)(6) 2009, dr.(b)(6) removed a suture from the patient's vagina.In (b)(6) 2009, a vaginal sinus was discovered.On (b)(6) 2009, dr.(b)(6) excised two fistula tracts, removed two green ethibond sutures from the 2007 surgery, repaired the anal sphincter with stitches, and repaired the rectovaginal fascia with a surgisis 7x10 graft.

• Brand Name: BIODESIGN 4-LAYER TISSUE GRAFT
• Type of Device: SURGISIS ES
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 5344961
• MDR Text Key: 35089803
• Report Number: 1835959-2016-00001
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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