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

Catalog Number ASD44E

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

Patient Problems Fever (1858); Chills (2191); Thrombosis/Thrombus (4440)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

H3, code "other" and h6, type of investigation, code b17: the explanted device is currently being investigated by the hospital.Gore will attempt to obtain the investigation results.H6, code c19: the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.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 to gore that on (b)(6) 2024, a 44 mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 24 to 25 x 15 mm after balloon-sizing and a deficient aortic rim measuring 2 mm.No issues were reported during deployment and the device was confirmed well positioned during fluoroscopy and ultrasound imaging.On (b)(6) 2024 however, the patient returned to hospital with fever and chills.Subsequent imaging showed significant formation of mass on both discs and floating structures on the right disc.Reportedly, the device was explanted on january 19, 2024.The patient reportedly received three prophylactic antibioses during the procedure.Also, antiplatelet medication was administered prior to and after the procedure and an activated clotting time of 352 seconds was upheld during the procedure to prevent thrombus formation.Reportedly, the explanted device is currently undergoing microbiological and histopathological examinations at the hospital facilities.

Event Description

It was reported to gore that on (b)(6) 2024, a 44 mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 24 to 25 x 15 mm after balloon-sizing and a deficient aortic rim measuring 2 mm.No issues were reported during deployment and the device was confirmed well positioned during fluoroscopy and ultrasound imaging.The patient reportedly received three prophylactic antibioses during the procedure.Also, antiplatelet medication was administered prior to and after the procedure and an activated clotting time of 352 seconds was upheld during the procedure to prevent thrombus formation.On january 17, 2024 however, the patient returned to hospital with fever and chills.Subsequent imaging showed significant mass agglomeration on both discs and floating structures on the right disc.Therefore, the device was reportedly explanted on (b)(6) 2024.The microbiological examination on the explanted device as reported to the physician yielded unremarkable findings.No additional information has been received for this patient.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.The explanted device was reported retained by the healthcare facility for an explant examination.Microbiological findings reported to the physician were unremarkable.Gore made multiple attempts over an extended period of time and requested additional information on the examination results on the explanted device.No further results were reported to gore in support of the mass agglomeration suggested by medical imaging on 17 january 2024, while the device was still implanted.Therefore, the allegation of a device thrombus could not be independently confirmed during the investigation.According to the gore® cardioform asd occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.

• 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: 18694745
• MDR Text Key: 335246656
• Report Number: 2017233-2024-04622
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 05/08/2024

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 Catalogue Number: ASD44E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 88 KG