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

Catalog Number ASD32B

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

Patient Problem Arrhythmia (1721)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

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: new arrhythmia requiring treatment.

Event Description

It was reported the physician implanted a 32mm gore® cardioform asd occluder on (b)(6) 2020.At a follow-up appointment on (b)(6) 2020, an atrial tachycardia was noted.The patient was cardioverted on (b)(6) 2020, and is now in sinus rhythm.No issues with the device.

• 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10631185
• MDR Text Key: 209965968
• Report Number: 2017233-2020-01329
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Catalogue Number: ASD32B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Date Device Manufactured: 06/18/2018
• 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): Other
• Patient Age: 4
• Patient Weight: 15