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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number FS0915
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 12/07/2021
Event Type  Injury  
Event Description
It was reported by the field sales associate that the physician used the gore® bio-a® tissue reinforcement for a breast reconstruction procedure. Reportedly, the patient experienced seroma and infection. It was reported the physician removed the device due to the infection. Reportedly, the patient is doing well according to the follow ups. Reportedly, the device was explanted 3 weeks after intervention and was removed via skin incision. It was reported the infection was treated with antibiotics and the mesh was removed. Reportedly, there was a wound dehiscence and there were drains placed during the procedure. It was reported the seroma was aspirated. Drained and the device was placed next to well vascularized tissue on both sides.
 
Manufacturer Narrative
Patient identifier: no patient specific details have been provided. Therefore, the patient initials reflect the w. L. Gore internal case number. Age or date of birth-weight: age, gender, and weight requested, but not provided. A review of the manufacturing and sterilization records for the device verified that the lot met all pre-release specifications. The device was not returned to gore; therefore, an engineering evaluation could not be performed. (b)(4). Contraindications: the gore® bio-a® tissue reinforcement is contraindicated for use in reconstruction of cardiovascular defects. Because gore® bio-a® tissue reinforcement is absorbable, it is contraindicated for use in patients requiring permanent support from the device. The instructions for use (ifu) for the gore® bio-a® tissue reinforcement state: possible adverse events with the use of any tissue deficiency prosthesis or soft tissue reinforcement surgical procedures may include, but are not limited to, additional intervention including surgery, adhesions and related harms, bowel obstruction, defect recurrence and related harms, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, and wound dehiscence. As with any mesh, use of gore® bio-a® tissue reinforcement in the presence of contamination may result in fever, infection, irritation or inflammation, pain, and wound dehiscence, and may require removal of the mesh if infection occurs. 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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint. 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.
 
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Brand NameGORE® BIO-A® TISSUE REINFORCEMENT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
angela brown
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14680788
MDR Text Key294058072
Report Number3003910212-2022-01377
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K033671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFS0915
Device Catalogue NumberFS0915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2020
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: 06/13/2022 Patient Sequence Number: 1
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