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

Catalog Number GSX0030A

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.The left disc was positioned in the left atrium at which time the physician requested to switch from intracardiac echocardiography to transesophageal echocardiogram for better visualization.The physician attempted to retrieve the device at this time; however, the slider would not slide back past the midway point and the device was still fully formed.The physician then locked the device, planning to remove the device using the retrieval cord; however, the physician could not get the center eyelet into the catheter.A snare was used to assist with capturing the device when it was still attached to the retrieval cord, however, at this time the cord broke and the device embolized to the pulmonary artery.The device was successfully snared and removed and a second 30mm gore® cardioform septal occluder was implanted.

Manufacturer Narrative

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

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.Engineering evaluation: the device was returned with the delivery catheter detached from the catheter assembly.The occluder was attached to the end of the delivery catheter with a snare used during retrieval, no retrieval cord was present.The occluder shape and size was consistent with being retrieved.The control shuttle and lock release shuttle cycled normally once the occluder and snare were removed.The physician¿s claim that the control shuttle would not cycle past the midpoint when retrieving could not be confirmed during the evaluation but was likely caused by misuse of the device.Based on the returned state of the device, and the occluder being retrieved by a snare, the delivery system could not be tested with the occluder attached to the catheter assembly.Therefore, the cause of the control shuttle resistance felt by the physician could not be determined, and the root cause for the inability to retrieve the device was that the right eyelet of the occluder was caught on the delivery catheter guidewire port, therefore indicating an unintended use error caused or contributed to the event.

• 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: 18247228
• MDR Text Key: 329492152
• Report Number: 2017233-2023-04442
• 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,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male