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

Model Number GSX0030A

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 12/21/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight was requested but was not available the gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: device embolization 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.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo).Under ultrasound guidance, the physician accessed the right and left femoral veins and inserted a 10f sheath in the left femoral vein and a 11f sheath in the right femoral vein.After securing access to the appropriate vessels, he advanced an mpa catheter over a standard j wire through the 11f sheath, across the pfo and into the left upper pulmonary vein (lupv).The physician then advanced the intracardiac echocardiography (ice) catheter through the 10f sheath, parking it in the right atrium.After visualizing the intra atrial septum, he decided that a 30mm gso was the appropriate device for this anatomy.The standard j-wire was replaced by a long stiff wire which was parked in the lupv.The physician prepped the device and advanced it over the stiff wire into the left atrium (la).After pulling the stiff wire, he deployed the device without incident.After visualizing the device using ice, we agreed it was positioned properly and he attempted to lock the device.During the locking step, the right disc elongated causing the locking loop to be missed.It appeared on inspection that the grey slider may not have been completely positioned all the way to the left and down in the track.The physician attempted to retrieve the device, during which, the retrieval cord snapped, leaving the right disc completely inside the sheath, and the left disc formed in the la.The physician tried several time to snare the 30mm device through the sheath, but was unable to get a snare around the device.After trying to reposition the device, the right disc was ejected from the catheter, but failed to form properly, causing the device to embolize into the la, eventually settling in the abdominal aorta.The physician then accessed the right femoral artery and inserted a 14f gore dry seal sheath.Using a 35mm loop snare, he was able to extract the 30mm gso.After successfully snaring the first device, a second 30mm gore® cardioform septal occluder was implanted without incident.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16111153
• MDR Text Key: 306777926
• Report Number: 2017233-2023-03622
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Date Device Manufactured: 02/22/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female