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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event has been requested.According to the instructions for use (ifu) for gore® synecor intraperitoneal biomaterial, correct surface orientation is important for gore® synecor intraperitoneal biomaterial.Incorrect parietal (non shiny) surface placement with unnecessary contact with internal organs may result in adhesions, erosion, extrusion, fistula, infection, irritation or inflammation, pain, and additional intervention including surgery.

Event Description

It was reported by the gore field sales associate that a surgeon used gore® synecor intraperitoneal biomaterial for a hernia repair.The surgeon previously told the fsa, several months ago, that his patient experienced a bowel obstruction following the hernia repair.The surgeon did not report that the bowel obstruction was device related.According to the fsa, the surgeon returned the patient to the operating room to address the obstruction.Later, the surgeon told the fsa that the device had been implanted upside down (with the film side in contact with the peritoneum instead of the viscera).At that time, the surgeon said that they did not consider this event to be caused by the device and instead was likely due to his technique in implanting the device upside down.

Manufacturer Narrative

H6.Conclusion code 1 - multiple attempts were made to get additional information, however no response from the complainant was received, the event will be closed with the reported information.

Manufacturer Narrative

B3.As the field sales associate stated the date of event occurred early 2019, the estimated date of event will be (b)(6) 2019.

Manufacturer Narrative

B4 and g4 updated to january 1, 2019 - after further conversation with the sales associate we found out the fsa was made aware of the event early last year.Therefore, the date gore aware will be estimated as january 1, 2019.

• Brand Name: GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9733302
• MDR Text Key: 180183274
• Report Number: 3003910212-2020-00023
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K152609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other