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

Catalog Number GSXE0030

Device Problems Difficult to Remove (1528); Material Separation (1562); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal 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: device embolization.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.The device was implanted without issue; however, once the device was locked the physician pulled the handle prior to the device being released.The physician then started to move the slider to the right of the handle, stopped, and began to push the slider back to the left in the fully engaged position.The physician then unlocked the luer lock and attempted to retrieve the device using the retrieval cord.The physician struggled to get the right eyelet into the delivery system and during this time the retrieval cord snapped.The delivery system was removed and the device embolized into the pulmonary artery.The device was snared with a 25mm goose neck snare and retrieved without further issue.A second 30mm gore® cardioform septal occluder was implanted with no adverse effects.

Manufacturer Narrative

Added additional medical device problem code.Added additional investigation conclusion code.

• Brand Name: GORE CARDIOFORM SEPTAL 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: 11251587
• MDR Text Key: 229352436
• Report Number: 2017233-2021-01633
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 93