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

Catalog Number GSXE0025

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Device evaluated by manufacturer?: engineering evaluation could not be performed as the device was discarded.

Event Description

It was reported to gore that a 25mm gore® cardioform septal occluder was intended to be used to treat a patient with patent foramen ovale.The patient did not have aneurysm in the septum, did not have long tunnel, neither thick septum.The measure of the tunnel was 9mm and the aperture of the tunnel in valsalva was measured 5mm.The device was successfully implanted on (b)(6) 2021 (checked by fluoroscopy and by tee).One day post-implant, an echocardiogram was performed before patient discharge and it was found that the device had embolized to the abdominal aorta.The physicians recaptured the device easily with a snare without any injury for the patient.A new echocardiogram will be performed to look at the septum of the patient.

Manufacturer Narrative

Imaging evaluation: it was reported that a 25mm gore cardioform septal occluder was implanted successfully into a pfo.The next day the device was found to have embolized to the aorta.From the imaging provided the device appears to have been successfully implanted onto the atrial septum.The left and right discs appear to be on the appropriate sides of the atrial septum and evenly distributed on both echocardiography and fluoroscopy.The device appears to have locked successfully.Images of the fully deployed and released device were not submitted for review.Limited initial assessment images were provided for review.It is difficult to assess the pre deployment anatomy with the limited images provided.The following day the device was found, fully intact with all parts present on fluroscopy, embolized to the aorta.From the imaging provided the cause for the embolization cannot be ascertained.Images of the explanted occluder showed the occluder appropriately locked with generally unremarkable appearance with the following exceptions.The eptfe of one of the discs was torn in at least one location.Based on the lack of pooled blood within the explanted occluder, it is likely the tear occurred during extraction of the occluder with the snare.The wire bumper of the left atrial eyelet was not visible in the images of the explanted occluder.Cross referencing with the echocardiography and fluroscopy images, the occluder is fully intact with the bumper visible both during deployment and after embolization to the aorta.Based on the imaging evidence, the occluder was intact, with all components present, up to the point of extraction with the snare.Engineering evaluation of images of the explanted occluder indicate the eptfe and bumper on the left atrial eyelet may have been damaged during snare extraction of the occluder.Aside from this damage, the appearance of the occluder is unremarkable.The cause of the embolization of the occluder is unknown and cannot be determined from the returned images.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11875141
• MDR Text Key: 252347463
• Report Number: 2017233-2021-02025
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 69