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

Catalog Number ASD44H

Device Problem Malposition of Device (2616)

Patient Problem Unspecified Heart Problem (4454)

Event Date 06/19/2022

Event Type  Injury  

Event Description

It was reported the physician was implanted a 44mm gore® cardioform asd occluder on (b)(6) 2022.At implant a partial prolapse was noted, but the hope was that the device would endothelize.On (b)(6) 2022, the device was snared out of the patient in an additional transcatheter procedure because of a partial prolapse and shunt.The patient is doing well following the procedure.

Manufacturer Narrative

Patient weight not available.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 imaging evaluation stated the following: it was reported that a gore cardioform asd occluder was implanted.At implant a portion of the device was prolapsed off the atrial septum.There was limited imaging provided from the initial implant.From the limited echocardiography imaging provided the aortic rim and posterior rims appear to be deficient.There were no images provided with balloon sizing, it is recommended that balloon sizing of the defect be performed to choose an appropriately sized device.The limited echocardiography images provided do show the device deployed on the atrial septum.The device appears to be in a satisfactory position although limited views were provided so this could not be confirmed.In the fluoroscopy images provided there is no spacing between the left and right discs on a portion of the device.This appearance is typical of a partial prolapse of one of the discs of the device.In the images provided from the removal of the device, a large portion of the device is prolapsed through the defect in the echocardiography images provided.The device was successfully removed in a transcatheter procedure.Per the performing facility the patient is doing well.

• 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: 15265987
• MDR Text Key: 298310002
• Report Number: 2017233-2022-03250
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD44H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: 49 YR
• Patient Sex: Female