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

Catalog Number GSXE0030

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

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

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported to gore that two years ago, a 25mm or 30mm gore® cardioform septal occluder was selected to treat an atrial septal defect.The patient was also reported to have had pre-existing atrial fibrillation at that time.During a follow-up ultrascan examination, the device, however, was not found at the expected location.Subsequent computed tomography (ct) imaging determined the device at the level of the iliac artery junction.It was reportedly suspected that the migration might have happened in timely proximity to the implant and that there might have been a device size issue.The physician was considering explanting the device.Reportedly, the patient was doing very well and participating in physical activities.No symptoms were reported.

Manufacturer Narrative

"other" code - the device remains in the patient.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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

A1 - a4: added patient information; b5, describe event or problem: updated event description; d4: added data; d6a / d6b: updated dates; d8/d9: added information; h6 evaluation codes: codes have been added/updated to reflect the extent of the investigation performed.Additional manufacturer narrative: the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.Imaging evaluation summary: electronic files containing medical images were returned to gore and an imaging evaluation was performed.In the ct image dated (b)(6) 2022, a gore® cardioform device can be visualized in the distal aorta.In the echo imaging provided, the device does not appear to be appropriately secured around the rim to the superior vena cava.Additionally, with the xray imaging provided, there is not clear disc separation between the left and right discs of the device.It is suspected based off of the imaging provided that the device that was selected was too small for the anatomy but without additional imaging this cannot be confirmed.Additional images were requested from the hospital but were not available.Explant evaluation summary: the device was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore® cardioform septal occluder.The surface of both the left and right discs were generally devoid of tissue apart from minute plaques of white, friable, soft tissue.The intercompartment of the discs contained scant, white, friable foci consistent with fibrin thrombus.On the peripheral wire of the waist, there was an 11mm long membrane of white to translucent soft tissue.There was no locking loop present on the right face of the disc, with malformation of the right disc.High-resolution radiographs were obtained and no wire discontinuities were observed.Histopathology and post-digestion evaluation of the device were not performed due to the nature of the complaint (device embolization post procedure).According to the gore® cardioform septal occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: device embolization.Additionally, in its recommended procedure section on defect sizing, the ifu states the following: a minimum occluder to defect size ratio of 1.75:1 is recommended.The defect size should be no greater than 17 mm.An occluder that pulls through the defect after disc conformation may be too small and should be removed and replaced with a larger size.The septal tissue margins surrounding the defect must be ofsufficient size and integrity to prevent disc prolapse through the defect and occluder embolization.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

Event Description

It was reported to gore that on (b)(6) 2020, a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo) with a very floppy septum.The patient was also reported to have had pre-existing atrial fibrillation at that time.During a follow-up ultrascan examination, the device, however, was not found at the expected location.Subsequent computed tomography (ct) imaging on (b)(6) 2022 determined the device at the level of the iliac artery junction.It was reportedly suspected that the migration might have happened in timely proximity to the implant and that there might have been a device size issue.Also, it was reported that the pfo had been closed on an unknown date with am amplatzer¿ occluder.Reportedly, the patient was doing very well and participating in physical activities.No symptoms were reported.On (b)(6) 2023, the physician explanted the device.The patient tolerated the procedure.

• 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
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16153252
• MDR Text Key: 307258396
• Report Number: 2017233-2023-03640
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 09/19/2023
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 108 KG