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

Catalog Number ASD32E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2021, a 32mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring approximately 12 mm without an aortic rim.During routine follow-up on (b)(6) 2022, the ultrasound scan revealed a substantially sized thrombus on the device.Reportedly, the patient was fine and taking double antiplatelet medication.Additionally, oral anticoagulant therapy had been scheduled to start soon with the patient remaining in hospital to undergo thrombus monitoring.It was also reported that the patient had suffered a covid infection two weeks ago which the treating physicians believe this might have been a potential cause for the observed thrombus.

Manufacturer Narrative

The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.

Manufacturer Narrative

H6: health effect - impact code: added imdrf codes f12, f08.H6: component code: added imdrf codes g04088, g04027.H6: type of investigation: added imdrf codes b11, b20.H6: investigation conclusions: added imdrf code d12.Code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.Imaging evaluation summary: echocardiography images dated (b)(6) 2022 were returned to gore for image review.The images revealed a large echogenic mass on the left disc of the gore cardioform asd occluder.The echogenic mass is mobile and eccentric in shape.It is located on the inferior portion of the left disc and extends out near the atrioventricular valve.The echogenic mass measured around 1.48mm x 1.58mm in diameter.Apart from that, the occluder looks stable and there is no display of residual shunt at the atrial level.The device remains implanted.Therefore, an engineering evaluation could not be performed.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.Adverse events associated with the use of the septal occluders may include, but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.H6: health effect - clinical code: replaced fda code 4440 with imdrf code e5014.H6: health effect - impact code: replaced fda code 4644 with imdrf codes f2303.H6: medical device problem code: replaced fda code 2993 with imdrf code a24.H6: type of investigation: replaced fda codes 3331, 4111, with imdrf codes b14, b13.H6: investigation findings: replaced fda code 213 with imdrf code c19.H6: investigation conclusions: replaced fda code 11 with imdrf code d15.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13564504
• MDR Text Key: 286445378
• Report Number: 2017233-2022-02752
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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 Expiration Date: 09/29/2023
• Device Catalogue Number: ASD32E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 44 KG