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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE SYNECOR INTRAPERITONEAL BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number GKFV1520
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Hernia (2240); Not Applicable (3189); No Code Available (3191)
Event Date 11/30/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). (b)(6). It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, pain, exposure (extrusion), bowel obstruction and recurrence. 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, infection, inflammation, adhesion, fistula formation, seroma formation, perforation, wound dehiscence, wound complications, pain, bowel obstruction, ileus, revision/resurgery, device contraction, fever, hernia recurrence. ¿.

 
Event Description

It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2015, whereby a gore dualmesh® plus biomaterial was implanted. It was reported to gore that the patient underwent hernia repair (type unknown) on (b)(6) 2016, whereby a gore® synecor biomaterial was implanted. The complaint alleges that on (b)(6) 2016, an additional procedure was performed whereby explant of the gore device was performed. The complaint alleges that on (b)(6) 2018, an additional procedure was performed whereby explant of the gore device was performed. It was reported the patient alleges the following injuries: additional surgery, extensive lysis of adhesions, recurrent hernia, mesh failure, mesh removal. Additional event specific information was not provided.

 
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Brand NameGORE SYNECOR INTRAPERITONEAL BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key8063851
MDR Text Key126918514
Report Number3003910212-2018-00109
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/13/2019
Device MODEL NumberGKFV1520
Device Catalogue NumberGKFV1520
Device LOT Number15186757
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2016
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: 11/13/2018 Patient Sequence Number: 1
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