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

Model Number GSX0025A

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

Patient Problem Stroke/CVA (1770)

Event Date 09/03/2020

Event Type  Injury  

Event Description

It was reported the physician implanted a gore® cardioform septal occluder.No device issues were noted during the implant.Shortly after the delivery catheter was removed, the patient was noted to have had a stroke.The stroke occurred in the same vessel as the patient¿s previous stroke.Fibrotic old thrombus was removed from the vessel during the transcatheter procedure.There was no thrombus on the implanted occluder and act levels were high during the procedure.

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: stroke.

• 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: 10706359
• MDR Text Key: 212276929
• Report Number: 2017233-2020-01371
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 54