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

Model Number ASD44A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Atrial Fibrillation (1729)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: hadi beaini and jamil a.Aboulhosn.(2022) percutaneous management of late occluder dislodgement: a case report.International journal of cardiology congenital heart disease 8 (2022) 100369.The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: new arrhythmia requiring treatment.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

The following article was received by gore: ¿percutaneous management of late occluder dislodgement: a case report¿.Published online - international journal of cardiology congenital heart disease 8 (2022) 100369.The article presents the case of a 65 female with a 2.5 cm asd, left atrial hypertension, deficient retroaortic rim, mobile septum primum and hypertrophied septum secundum.She underwent uncomplicated closure with a 44-mm gore® cardioform asd occluder (gca).However, the patient presented to the emergency room five weeks post procedure and was found to be in atrial fibrillation with rapid ventricular response at a rate of 158 bpm.Further workup showed a dislodged gca device despite appropriate device placement and size selection based on the published instructions for use.We elected to not remove the 44-mm gca given that it had become adherent to the septum primum but instead used the stiffer amplatzer septal occluder to stabilize the gca and occlude the residual defect.

• Brand Name: GORE® CARDIOFORM ASD 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15042426
• MDR Text Key: 296068781
• Report Number: 2017233-2022-03133
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2021
• 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: 65 YR
• Patient Sex: Female