MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES UNKNOWN

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem Tissue Damage (2104)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

The mesh is alleged to be a gore device, however the lot number was not reported.The implant date is not known, but is estimated to be 2007.A review of the manufacturing records could not be conducted because the lot number is unavailable.Gore has requested medical records from the reporter.

Event Description

It was reported to gore by the patient's father that his son underwent an appendectomy at age (b)(6) and a large scar remained and four hernias developed in the area.It was reported the son underwent a hernia repair in 2007 in which one alleged gore mesh was used to repair the four hernias.It was further alleged that the gore mesh along with metal staples "came loose and became entangled in the patient¿s intestines." the patient¿s father reported that on (b)(6) 2016, his son underwent surgery and the alleged mesh was removed along with his intestines and only a foot of the intestines remains.

Manufacturer Narrative

According to the report, the patient was scheduled for a follow up visit in (b)(6) 2017 to determine if he was a candidate for intestinal transplant.However, no medical records from the follow up visit were provided.Further communication with the complainant indicated the implanted mesh device was not a gore device.Based on the additional information received indicating this patient was not implanted with a gore device, this medwatch report is being retracted.

• Brand Name: UNKNOWN
• 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: cheryl hawke ; 301 airport rd.; elkton, MD ; 9285263030
• MDR Report Key: 6449221
• MDR Text Key: 71393873
• Report Number: 3003910212-2017-00017
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 86