MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN TENSION FREE URETHRAL SLING; STRATASIS TENSION FREE URETHRAL SLING

Catalog Number J-STF-8-2X40

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Inflammation (1932); Ulceration (2116)

Event Type  Injury  

Manufacturer Narrative

Concomitant products - over 20% of the patients had concomitant anterior with / without posterior mesh repair; additional product unspecified.This mdr is related to mdr 1835959-2016-00058, mdr 1835959-2016-00059, and mdr 1835959-2016-00060.A review of the cbi complaint database did not reveal any previously reported complaint of graft-versus-host disease.The ifu notes that infection, chronic inflammation, and delayed or failed incorporation of the device as some of the potential complications that are possible with the use of surgical graft materials.Graft-versus-host disease (gvhd) occurs when transplanted donor cells attack the patient's body.This is not a possible occurrence when an acellular graft, such as the stratasis tension-free urethral sling, is implanted into the patient.Therefore, the root cause of the reported ulceration, exudation, and inflammation is inconclusive.(b)(4).

Event Description

A journal article, from the kaohsiung journal of medical sciences, reported four instances of graft-versus-host disease.The article is attached.The article reported "xenografts were used for midurethral slings in order to lower the incidences of extrusion and infectious complications with synthetic grafts.In this study, no mesh extrusion was noted in our patients, supporting the above suggestion.However, graft-versus-host reaction (gvhd) developed in four of our patients.Ulceration and exudation developed in all of them and persisted after debridement and the usage of antibiotics.Gvhd was diagnosed by the histological findings of the subepithelial cleft and an apoptotic keratinocyte in the squamous epithelium with lymphocyte infiltration (exocytosis) and focal hydropic change (spongiosis) as in grade 3 gvhd.For these cases, prednisolone (donison, china chemicals, taipei city, taiwan) was given for 1 month and a maintenance dose of 30 mg/d for 1 more month.Finally, the wound resolved gradually after a 2-month course of treatment [14].In addition, intense postoperative inflammation had also been reported [15,16].".

• Brand Name: BIODESIGN TENSION FREE URETHRAL SLING
• Type of Device: STRATASIS TENSION FREE URETHRAL SLING
• 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: 5650811
• MDR Text Key: 45092783
• Report Number: 1835959-2016-00057
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K020654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-STF-8-2X40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2016
• 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): Required Intervention