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U.S. Department of Health and Human Services

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

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COOK BIOTECH BIODESIGN TENSION FREE URETHRAL SLING STRATASIS TENSION FREE URETHRAL SLING Back to Search Results
Catalog Number J-STF-8-2X40
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
Date of event not provided by the complainant. Lot number not provided by the complainant. Product expire date unknown; lot number not provided. Surgeon name not provided by the complainant. Implant date not provided by the complainant. Concomitant products - over 20% of the patients had concomitant anterior with / without posterior mesh repair; additional product unspecified. Product manufacture date unknown; lot number unknown. This mdr is related to mdr 1835959-2016-00057, mdr 1835959-2016-00058, and mdr 1835959-2016-00059. 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.
 
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 midureteral 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, (b)(4)) 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]. ".
 
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Brand NameBIODESIGN TENSION FREE URETHRAL SLING
Type of DeviceSTRATASIS 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 Key5650761
MDR Text Key45062215
Report Number1835959-2016-00060
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K020654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,study
Reporter Occupation
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 Received05/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberJ-STF-8-2X40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/12/2016 Patient Sequence Number: 1
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