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

Model Number GSX0025A

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Early 40¿s female with recent cerebrovascular accident and patent foramen ovale.Procedure: closure of patent foramen ovale.Problem was a deployment issue; the device would not lock in place.Another device used without problems, no known harm to patient.Discharges same day.Manufacturer response for transcatheter septal occluder, gore cardioform septal occluder (per site reporter).Will obtain.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 14674160
• MDR Text Key: 293835096
• Report Number: 14674160
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: (01)00733132631025(17)23776510(10)GSX0025A
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GSX0025A
• Device Catalogue Number: GSX0025A
• Device Lot Number: GSX0025A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Female
• Patient Weight: 62 KG