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

Model Number GSX0030A

Device Problem Migration (4003)

Patient Problems Tachycardia (2095); Foreign Body Embolism (4439)

Event Date 03/02/2023

Event Type  Injury  

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.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 for platypnea orthodeoxia.The defect anatomy was aneurysmal and with a stiff amplatz wire across measured 11mm wide in multiple planes.The device was deployed without difficulty, a push pull maneuver was done demonstrating stability.No color was seen crossing the device and the bubble study post release was negative.The following day the patient was experiencing heavy coughing and while walking on the hospital floor her telemetry demonstrated she was getting tachycardic.A chest x-ray was performed and showed the device had embolized right to left and was in a stable position just past the aortic arch.The device was snared successfully and the patient is doing fine post procedure.The device was discarded.The patient to be scheduled for another catheterization procedure.

Manufacturer Narrative

The evaluation of the returned occluder showed the following: the overall size and shape of the occluder and its bumper were unremarkable.The distal eyelet was damaged in its returned state.The embolization of the occluder could not be recreated nor confirmed during the evaluation.Thus, the cause of the complaint is unknown and cannot be determined from the evidence available.H6: updated code b18 to b01.

• 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: 16544802
• MDR Text Key: 311303207
• Report Number: 2017233-2023-03790
• 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: 05/12/2023

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 Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 54 KG