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

Catalog Number ASD44B

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

Patient Problems Fever (1858); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing and sterilization records for the device verified that the lot met all pre-release specifications.Images were provided and reviewed: on the limited echocardiography imaging provided, the right atrial disc does appear to have an echogenic mass attached to it.This mass appearance is consistent with thrombus.The left atrial disc does appear to have an echogenic mass inside of the disc.This mass appearance is also consistent with the appearance of thrombus.It is difficult to ascertain from the imaging provided what caused of the formation of thrombus.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: fever, device thrombosis or thromboembolic event resulting in clinical sequelae.

Event Description

It was reported to gore a 44mm gore® cardioform asd occluder was implanted on (b)(6) 2021 to treat a secundum atrial septal defect and right ventricle dilation.The defect was balloon sized to 22mm.The septum was mobile with deficient aortic rim.The patient has no history of pro thrombotic issues, is a current smoker, and in the past has had a possible reaction to jewelry and zinc.Initially a 37mm gore® cardioform asd occluder device was attempted but was unstable so the 44mm gore® cardioform asd occluder was implanted.Intravenous cefazolin 2g was given at time of the procedure.The patient was on aspirin and preloaded with clopidogrel.The patient was doing well post procedure and on transthoracic echocardiogram (tte) day one looked excellent, with the device well seated, no effusion, no masses on device.It was reported the patient experienced fevers and sweats the night of (b)(6) 2021.On (b)(6) 2021 the patient presented to another hospital with high fever.Blood cultures are still negative from that visit.Intravenous tazocin was given and the patient self discharged.The patient was readmitted to the implanting facility on (b)(6) 2021 with ongoing fevers.White cell count 16 with neutrophilia.C-reactive protein 60.Repeat blood cultures x 3 were negative.The patient was managed with intravenous cefazolin and vancomycin.Tte on (b)(6) 2021 demonstrated small masses on right atrium side.Repeat tte (b)(6) 2021 demonstrated large masses on right atrial disc with small pericardial effusion.Trans-oesophageal echocardiogram (b)(6) 2021 demonstrated thick material on the left disc and masses on the right disc.Intravenous unfractionated heparin (ufh) was commenced then.Surgery was performed (b)(6) 2021, with explantation of the device.Fibrinous material with thrombus, no significant pus/ abscess was seen.Initial gram stain demonstrates polymorphs but no bacteria seen.Histopathology pending.The physician suspects the patient has had some sort of inflammatory reaction to the device as it seems too acute for infection.2600-a other is being used for fever and sweats.

Manufacturer Narrative

H6: added type of investigation code 4111.Added conclusion code 4315.A1, a2, a4-the following information was requested but not provided: patient initials, weight and date of birth.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: fever, device thrombosis or thromboembolic event resulting in clinical sequelae histology evaluation: the device was requested but was not returned for evaluation; however, histological tissue slides were returned and examined.Microscopic examination of the returned tissue slides was performed by the research pathologist.Overall impression supports an acute severe inflammatory disease process accompanied by severe acute thrombosis.Because submitted thrombus, cardiac tissue and eptfe specimens possessed similar inflammatory responses, it can be surmised they are part of the same disease process.The underlying etiology could not be definitively determined though infection is not supported by microscopic examination of submitted slides.

• 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: 12802845
• MDR Text Key: 281013844
• Report Number: 2017233-2021-02530
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 04/26/2022

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: 04/11/2024
• Device Catalogue Number: ASD44B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 04/26/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male