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

Catalog Number GSX0030A

Device Problems Use of Device Problem (1670); Structural Problem (2506); Physical Resistance/Sticking (4012)

Patient Problem Pericardial Effusion (3271)

Event Date 06/12/2019

Event Type  Injury  

Event Description

It was reported, the physician selected a gore® cardioform septal occluder to close a patent foramen ovale (pfo) on (b)(6) 2019.The device was placed but did not look right.It was high and horizontal but the discs were splayed so the device was locked and left in place.Approximately 10-15 minutes post procedure a pericardial effusion was noted.A pericardial window surgical procedure was performed to drain excess fluid from the pericardium.The following day the patient was sent to a larger hospital for surgical device removal.The device was not on the atrial septum but was removed from a hole in the dome of the left atrium.The patient was doing well following the procedure.

Manufacturer Narrative

A4: patient weight was requested but not available.The device and images were requested from the hospital.The hospital will retain the device and no images will be made available.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8750499
• MDR Text Key: 149759374
• Report Number: 2017233-2019-00491
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17846821
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR