MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE HELEX SEPTAL OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product identification records for the alleged gore device was not provided.Therefore, a review of the manufacturing records could not be performed.Case imaging evaluation in progress.The device remains implanted, therefore an evaluation of the device could not be performed.The engineering report states the cause of the right disc of the device entering the tunnel is unknown and cannot be determined from the reported information.

Event Description

It was reported to gore a gore® helex® septal occluder was implanted in 2011 to close a patent foramen ovale.It was reported that sometime in (b)(6) of 2019, transesophageal echocardiography (tee) indicated the right disc had slid into the tunnel and bubble studies were positive.At that time it was reported the physician felt the device was stable and discussed treatment options with the patient.It was reported that on (b)(6) 2019 a procedure was to be performed to place a second device, a gore® cardioform septal occluder; however, echocardiography studies indicated the right disc was unlocked and a wire fracture was noted half way through the loop on the proximal side of the right disc.The procedure ended, the device was never opened, and the patient will be scheduled for surgery.No date is known at this time.

Manufacturer Narrative

H6: updated results/conclusions code 2 for imaging evaluation.H6: added results/conclusions code 4 for additional codes for imaging evaluation.The imaging evaluation states: from the imaging provided the right atrial eyelet is not captured by the locking loop, images from the initial deployment were not provided and it is difficult to assess if this occurred at the initial implant or sometime after.Part of the right disc does appear to have slid into the tunnel of the pfo, however, without echocardiography this cannot be confirmed.There also appears to be a frame fracture on the right atrial disc.Per the report the decision was made not to attempt another device for closure but to send the patient for surgical closure.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 an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".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.

Manufacturer Narrative

D6: added date of implant.As the exact date of implant in 2011 is unknown, an estimated date of implant of (b)(6) 2011 is being used.H1: corrected type of reportable event.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9401919
• MDR Text Key: 193657280
• Report Number: 2017233-2019-01201
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 78