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

Model Number ASD37A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Atrial Flutter (1730); Thrombosis/Thrombus (4440)

Event Date 04/28/2023

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: new arrhythmia requiring treatment and thrombosis of thromboembolic event resulting in clinical sequelae.The summary of the imaging evaluation stated the following: it was reported the physician implanted a 37mm gore® cardioform asd occluder on (b)(6) 2023.At a follow-up appointment on (b)(6) 2023, a suspected thrombus was noted on the right disc.In the initial echo image 1 provided from the day of implant, the device appears to be in a stable position.Without additional imaging this cannot be confirmed.In echo image 2, a large mass can be seen on the right atrial disc.It appears that the mass is contained in the right atrial disc indicating right disc expansion but without additional imaging, this cannot be confirmed.It also cannot rule out the possibility of thrombus on the exterior of the device or a right atrial myxoma.Without additional imaging, that cannot be confirmed.The patient was treated with an unknown anticoagulant.The patient was also noted to be in atrial flutter and was treated with beta blockers.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 the physician implanted a 37mm gore® cardioform asd occluder on (b)(6) 2023.At a follow-up appointment on (b)(6) 2023, a suspected thrombus was noted on the right disc.The patient was treated with an unknown anticoagulant.The patient was also noted to be in atrial flutter, and was treated with beta blockers.

Event Description

It was reported the physician implanted a 37mm gore® cardioform asd occluder on (b)(6) 2023.At a follow-up appointment on (b)(6) 2023, a suspected thrombus was noted in the right disc.The patient was treated with an unknown anticoagulant.The patient was also noted to be in atrial flutter, and was treated with beta blockers.Physician update: the right disc expansion caused the right atrial eyelet to come off the locking loop.The physician is planning on surgical removal of the device unless the right disc flattens out soon.

Manufacturer Narrative

The summary of the imaging evaluation stated the following: it was reported the physician implanted a 37mm gore® cardioform asd occluder on (b)(6) 2023.At a follow-up appointment on (b)(6) 2023, a suspected thrombus was noted on the right disc.In the initial echo image 1 provided from the day of implant, the device appears to be in a stable position.Without additional imaging this cannot be confirmed.In echo image 2, a large mass can be seen on the right atrial disc.It appears that the mass is contained in the right atrial disc indicating right disc expansion but without additional imaging, this cannot be confirmed.It also cannot rule out the possibility of thrombus on the exterior of the device or a right atrial myxoma.Without additional imaging, that cannot be confirmed.The patient was treated with an unknown anticoagulant.The patient was also noted to be in atrial flutter and was treated with beta blockers.Update: upon review of the additional fluoro images, a gore cardioform asd occluder can be visualized.In fluoro image one dated on (b)(6) 2023, a gore cardioform asd occluder can be visualized.The device has clear disc separation around the interior/posterior rim.Around the anterior/ superior rim, there is minimal disc separation between the left and right discs.On the fluoro image dated on (b)(6) 2023, the right atrial disc is elongated, and the device has become unlocked.This is indicative of right atrial disc enlargement.The tee images also confirm that the mass originally seen in the echo images 1 and two, is contained within the device.The cause for the right disc expansion cannot be determined.

Event Description

It was reported the physician implanted a 37mm gore® cardioform asd occluder on (b)(6)2023.At a follow-up appointment on (b)(6) 2023, a suspected thrombus was noted in the right disc.The patient was treated with an unknown anticoagulant.The patient was also noted to be in atrial flutter, and was treated with beta blockers.Physician update: the right disc expansion caused the right atrial eyelet to come off the locking loop.The device was removed and asd was closed in a surgical procedure.

Manufacturer Narrative

B5 - updated description.D6b- added explant date.

• 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: 16860826
• MDR Text Key: 314470079
• Report Number: 2017233-2023-03905
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• 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,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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): Other
• Patient Age: 31 YR
• Patient Sex: Male