MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN SURGISIS TENSION FREE URETHRAL SLING

Catalog Number J-STFK-8-2X40

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Fibrosis (3167)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a stratasis tension-free urethral sling on (b)(6) 2003 and on (b)(6) 2004 at (b)(6) and the gynecare tvt obturator system on (b)(6) 2012 at (b)(6) hospital in (b)(6).The products were implanted in the pt to treat her stress urinary incontinence.The pt and her attorney have alleged that as a result of these products being implanted in the pt, the pt has experienced pain, injury and has undergone corrective surgery.The following info was not provided by the complainant.Specific info of the alleged injury.Specific info regarding whether intervention was performed.Specific info regarding why intervention was performed or what type/ to what extent intervention was performed.Specific correlation between device performance and alleged injury current pt status.Pt had a 2nd tf sling placed after experiencing recurrence.One week f/u showed incision was healing nicely and no evidence of fluid collection.Three months post op the pt reportedly began experiencing right groin pain with no relief from pain medications.A ct of the pelvis was ordered.On (b)(6) 2004, the pt underwent a right groin exploration, mcvay herniorrhaphy, and excision of foreign material, performed by (b)(6) for foreign material in the oblique musculature of the abdominal wall and a femoral hernia.Dr (b)(6) indicated that though the external oblique aponeurosis extending medially, the sling material from previous bladder repair extended up through the abdominal wall, peritoneum and musculature.This material was excised as it was believed to be the source of the pt's pain.The pathology reported indicated reactive fibrosis with acute and chronic inflammation.A definitive foreign body was not identified.On (b)(6) 2012, the pt underwent a sling urethropexy, by (b)(6) at (b)(6) hospital for the treatment of her stress urinary incontinence.A gynecare tvt obturator system was placed in the pt.A finding during this surgery was that dissection down to prior sling revealed that they were likely fascial slings.The fascial sling was tightly adhered to the urethra.To prevent trauma or damage to the bladder neck and urethra, that tissue was not dissected off the urethra.On (b)(6) 2013, the pt underwent a durasphere injection again by dr (b)(6) for treatment of persistent mild incontinence after sling urethropexy.

Manufacturer Narrative

Result - no results available since no eval performed, as no product not returned to cbi.Conclusions - root cause inconclusive.This mdr is related to mdr 1835959-2013-00019.Investigation into this report has included: a review of the claim allegations.A review of the cbi complaint system, and all other communication and investigation into this report/claim is being handled by our attorney.Add'l investigation into this claim included: a review of the cbi complaint system.A review of the device history record, and a review of the biodesign tension free urethral sling ifu.Based on the info provided by the complainant, details regarding a specific correlation between the stratasis tension-free urethral sling's performance and the alleged injury remains unk.A root cause of the claim allegations is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when add'l info is obtained, that alters our conclusion to this complaint, the complaint will be reopened.After reviewing the details received, it does not appear that the stratasis tension free urethral sling caused or contributed to any life threatening illness or injury, permanent impairment or damage nor did the pt require medical or surgical intervention to preclude serious injury or death as a result of the graft being placed.The pt did not experience any symptoms as a result of the biodesign tension free urethral sling being placed that should they recur would be likely to cause or contribute to death, serious injury, or require medical or surgical intervention to preclude serious injury or death.The pt's complaint of right groin pain superseded her initial surgery of 2003.The presence of sling material extending through the abdominal wall and peritoneum is expected due to the procedure and is intended to remodel.It's presence at 4 months post-op is not unexpected.This along with the need to treat the femoral hernia could be a complicating factor in the presence of the pt's right groin pain.Chronic inflammation and recurrence are listed as potential complications associated with the use of this device in the ifu.

• Brand Name: BIODESIGN SURGISIS TENSION FREE URETHRAL SLING
• Type of Device: SURGISIS TENSION FREE URETHRAL SLING
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 3670088
• MDR Text Key: 4339323
• Report Number: 1835959-2014-00004
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/17/2014

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 Expiration Date: 09/30/2004
• Device Catalogue Number: J-STFK-8-2X40
• Device Lot Number: LB216475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2003
• 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): Hospitalization; Disability
• Patient Age: 44 YR