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

Catalog Number ASD48C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Arrhythmia (1721)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050006.

Event Description

It was reported the physician implanted a 48 mm gore® cardioform asd occluder (b)(6) 2019 to close an atrial septal defect balloon sized to 26 mm.On (b)(6) 2019, the patient was hospitalized and an electrocardiogram demonstrated supraventricular arrhythmia which was treated with cardioversion, oral, and iv rate control medications.The arrhythmia was documented as resolved (b)(6) 2019.On (b)(6) 2019 an electrocardiogram demonstrated supraventricular arrhythmia which did not require treatment but is documented as ongoing.

Manufacturer Narrative

H.6.Results code 1: a review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8781552
• MDR Text Key: 150733505
• Report Number: 2017233-2019-00517
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2019
• Device Catalogue Number: ASD48C
• Device Lot Number: 18088243
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 122