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

Model Number ASD27A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Date 10/06/2022

Event Type  Injury  

Event Description

It was reported to gore a 27mm gore® cardioform asd occluder was implanted on (b)(6) 2022 to treat an atrial septal defect.It was reported the patient presented to an outside emergency department on (b)(6) 2022 with fever/sepsis.The patient then presented to the implanting facility on (b)(6) 2022 with positive cultures and negative echocardiogram.The patient was admitted.The first echocardiogram that showed vegetation on the device was (b)(6) 2022.Repeat echocardiogram on (b)(6) 2022, while on multiple antibiotics and anticoagulants, showed progression of the vegetation.The patient had persistent positive cultures (mssa) and fever.The device was explanted on (b)(6) 2022.During the open cardiovascular procedure, a large vegetation could be seen on right atrial disc.There was also a small vegetation on the left atrial disc when removed.

Manufacturer Narrative

Patient weight was requested but was not provided.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.

Manufacturer Narrative

2600-a:-other is being used for fever, sepsis.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, sepsis, device thrombosis or thromboembolic event resulting in clinical sequelae.A review of the manufacturing and sterilization records for the device verified that the lot met all pre-release specifications.The explant evaluation of the returned device noted the following: submitted in formalin was a gore® cardioform asd occluder (asd).A small to moderate amount of light tan tissue was intermittently covering both discs and the internal compartments.Luminal surfaces of the right and left discs were partially covered in tissue with device eyelet and edges appearing uncovered in many regions.Tissue covering the luminal surface of the right disc consisted of fibroblastic tissue intermixed with suppurative inflammation, acute thrombus and necrosis.Disc internal compartments contained suppurative (neutrophilic) inflammation, acute thrombus, and necrosis.Staphylococci were sparsely present, particularly adjacent to or within device eptfe interstices.The device was subjected to an enzymatic digestion process to remove biologic debris.Post-digestion evaluation was not performed, due to the nature of the complaint (i.E., infection and thrombus formation).

• 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: 15666110
• MDR Text Key: 302347923
• Report Number: 2017233-2022-03422
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636488
• UDI-Public: 00733132636488
• 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
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD27A
• Device Catalogue Number: ASD27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: 3 YR
• Patient Sex: Female