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

Catalog Number ASD48E

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

Patient Problems Fever (1858); Thrombosis/Thrombus (4440)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2022, a 48mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 28-30mm (balloon sized) with a minimal aortic rim and posterior rim present about 5mm.The implantation was performed utilizing intracardiac echocardiography.A push and pull test showed the occluder after locking in a stable position and with no residual shunt.Post implantation, the patient reportedly suffered from high fever (40 degrees celsius) and chills.During multiple follow-up ultrasound examinations, the occluder device was found to be stable.On b)(6) 2022, both computed tomography and ultrasound imaging showed thrombus formation on the right disc and a residual shunt in the retro-aortal area.On (b)(6) 2022, the device was explanted due dislocation and an ongoing residual shunt.Reportedly, thrombus was also found on the left disc.During device implant, activated clotting time exceeded 240 seconds and a thrombolytic disorder is reportedly unknown.Following device explant, the physician surgically treated the defect.Post-operatively, it was reported that the patient was well.

Manufacturer Narrative

H6, health effect - clinical code: added imdrf code e230101.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.Histological findings of the explanted device as well as intra-operative images dated (b)(6) 2022, and post-operative images dated (b)(6) 2022 were requested from the physician via the reporting source.However, no additional information was received.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 codes 4625, 4627, with imdrf codes f1901, f12.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: 14674553
• MDR Text Key: 293837117
• Report Number: 2017233-2022-03009
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2024
• Device Catalogue Number: ASD48E
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 90 KG