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

Model Number	ASD44A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: new arrhythmia requiring treatment.
Event or Problem Description
It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect on (b)(6) 2021.Upon locking, the device prolapsed and was removed using the retrieval cord.A 44mm gore® cardioform asd occluder was then selected and successfully implanted.It was reported the patient presented on (b)(6) 2021 in first degree heart block.The patient is being treated with steroids and the device remains implanted.The physician reported on (b)(6) 2021 that the first degree heart block has completely resolved with medical management.The patient was discharged with a holter monitor and is doing well.

• Brand Name: GORE CARDIOFORM ASD OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11250843
• Report Number: 2017233-2021-01632
• Device Sequence Number: 14343455
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 18