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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE SYNECOR PREPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE SYNECOR PREPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Seroma (2069)
Event Date 05/01/2021
Event Type  Injury  
Manufacturer Narrative
Due to an unknown lot/serial number and no device return, an investigation could not be performed. Per the instructions for use (ifu) for the gore® synecor preperitoneal biomaterial, possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to adhesions and related harms, bowel obstruction, contamination, 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, mesh migration, mesh shrinkage, pain, paresthesia, seroma or hematoma and related harms, tissue ischemia, wound dehiscence, and additional intervention including surgery. As with any surgical procedure, there are always risks of complications for surgical repair of hernias, with or without mesh, these may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, hernia recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision/resurgery, seroma or hematoma and related harms, wound complications and wound dehiscence. Refer to ifu section warning and precautions for any additional information regarding adverse events and any steps that should be taken to avoid them, as well as information about other warnings and precautions. Procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.   procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative wound management.  patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene. There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code "4315: cause not established" is being used. Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.
 
Event Description
It was reported that the patient had a reintervention on (b)(6) 2021 for a recurrent hernia using gore® synecor preperitoneal biomaterial. Reportedly, the patient had a previous failed hernia repair many years ago. It was reported a drain was placed in the patient at the time of surgery, but the drain was removed and the seroma developed. It was reported 2 months post-op that a seroma formed that was drained more than one time. Reportedly, it is unknown if there is an infection, but the physician is suspicious because of the large amounts of drainage. Update: it was reported a permanent stitch was used to anchor the device at the time of implant in the onlay plane. Reportedly, only one device was used for the repair. It was reported there were signs of infection less than 1 month after the procedure. Reportedly, blake 19 french drains were used and an abdominal binder was used postoperatively to close the dead space. It was reported after persistent infection, the seroma required removal of the device. Reportedly, the lot/device number is unknown. It was reported the explant was device related.
 
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Brand NameGORE SYNECOR PREPERITONEAL BIOMATERIAL
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
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12368250
MDR Text Key268249044
Report Number3003910212-2021-01283
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163576
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/25/2021 Patient Sequence Number: 1
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