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 Heart Block (4444)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Adverse event problem investigation findings, 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) 2023, a 32mm gore® cardioform asd occluder was selected to treat an atrial septal defect without an aortic rim measuring 16 mm, using stop flow balloon sizing.Reportedly, the patient had now developed third degree atrioventricular block and treatment with steroids had been started.A wait-and-watch approach is being taken to decide if surgical removal of the device would be necessary.

Manufacturer Narrative

B5, describe event or problem: updated event description.Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.The device remains implanted.An evaluation of the device was therefore not performed.This complaint was initiated based on information received from the field.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore the cause of the reported heart block could not be independently confirmed during the investigation.The available information reported does not reasonably suggest a potential malfunction has occurred.Reported heart block represents a known complication or adverse event that can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.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: new arrhythmia requiring treatment.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

Event Description

It was reported to gore that on (b)(6) 2023, a 32mm gore® cardioform asd occluder was selected to treat an atrial septal defect without an aortic rim measuring 16mm after stop flow balloon sizing.On (b)(6) 2023, the patient was reported to have now developed third degree atrioventricular block and treatment with steroids had been started.On (b)(6) 2023 it was reported that the patient's situation had resolved under steroid therapy and an explant was no longer considered.

• 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: 16681489
• MDR Text Key: 312687666
• Report Number: 2017233-2023-03843
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD32E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 23 KG