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

Catalog Number ASD48H

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 01/14/2023

Event Type  Injury  

Manufacturer Narrative

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: device embolization the device was not returned for evaluation.Imaging evaluation: with the xray images received it appears in that the device is appropriately placed with equal number of petals on the left and right side of the septum.The device in the first xray image is not locked as visualized by the locking loop still contained in the control catheter.In the second xray imagean aggressive push/pull technique was visualized and it was used to verify the device stability and during this technique, it appears that there is a petal prolapse from the left atrial disc.This cannot be confirmed without additional imaging.In the third xray image, the device does not appear to be in the proper position as the left and right petals are not equal and symmettrical.It appears as there is a right atrial petal around the retroaortic rim that is prolapsed into the fossa ovalis.However, this cannot be confirmed without additional imaging.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 48mm gore® cardioform asd occluder was implanted on (b)(6) 2023 to treat an atrial septal defect balloon sized 32mm.The defect measured around 22x25mm without the use of the balloon.The retro-aortic rim was deficient and the pi rim was about 12mm long.Transesophageal echocardiogram was used and the ecocardiologist confirmed the device was well implanted and fluoroscopy seemed to be alright.It was reported that on (b)(6) 2023 the device embolized and they planned to remove it the same day.The physician tried by endovascular means but failed, as it was reported the device was located in the trunk of pulmonary artery.The device was explanted on (b)(6) 2023 and it was reported 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16478452
• MDR Text Key: 310610205
• Report Number: 2017233-2023-03774
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2023

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 Catalogue Number: ASD48H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/03/2023
• Date Device Manufactured: 09/15/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Weight: 66 KG