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

Catalog Number ASD48C

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Obstruction/Occlusion (2422)

Event Date 06/25/2021

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: chest pain or discomfort and device embolization.

Event Description

It was reported to gore a 48mm gore® cardioform septal occluder was selected to treat an atrial septal defect balloon sized to 28mm with a deficient retro aortic rim.A residual shunt was noted and the device was removed.A second 48mm gore® cardioform septal occluder was implanted and the patient was taken off the table and put on four hours of bed rest.The patient began having chest pain a few hours later and the device had embolized into the patients pulmonary artery.The patient remained hemodynamically stable.The physician snared the device out on the same day and the patient was reported to be doing fine with no further issues as of the next day.The patient will be scheduled to attempt implantation of another 48mm device in the future.(b)(4).

Manufacturer Narrative

H6: updated investigation findings and conclusions codes.

• 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
• MDR Report Key: 12195630
• MDR Text Key: 262409830
• Report Number: 2017233-2021-02182
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Catalogue Number: ASD48C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 80