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

Model Number GSX0025A

Device Problems Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Pfo (patent foramen ovale) closure device was deployed appropriately, multiple holes were seen, physician team attempted to deploy a second device and, in the process, the first deployed device became dislodged and ended up in the patient's left ventricle.The interventional cardiologist promptly made the patient aware, and in doing so made the team aware, called the cardiac surgeon on call and mobilized the patient to go for open heart surgery for retrieval of device and pfo closure.Upon arrival to or, patient was treated appropriately by anesthesia team, and when echo probe used for evaluation, it was noted that pfo device was no longer in the left ventricle.Pfo device was ultimately retrieved percutaneously by interventional cardiologist back in the cath lab after patient had been extubated and recovered in pacu.Manufacturer response for transcatheter septal occluder, gore cardioform septal occluder (per site reporter).

• 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: 14564307
• MDR Text Key: 293084951
• Report Number: 14564307
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White