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

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

Patient Problem Arrhythmia (1721)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p050006.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 to gore a 44mm gore® cardioform asd occluder was selected to close an atrial septal defect.The device was locked and in place; however, the device shifted and was removed as the physician did not like the position.A second 44mm gore® cardioform asd occluder was selected; however, during implant the patient developed an av dissociation arrhythmia.The patient was treated with two rounds of atropine with no response.The patient returned to a regular sinus rhythm with a pacer, however, the physician did not want to continue with the procedure.The patient left the catheterization lab and surgical closure will be discussed.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kathy titus ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 9740631
• MDR Text Key: 188245257
• Report Number: 2017233-2020-00117
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 7 YR
• Patient Weight: 19