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

Catalog Number GSXE0030

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device was not returned, therefore an engineering evaluation could not performed.

Event Description

The following was reported to gore: the patient presented with a patent foramen ovale (pfo), following cryptogenic stroke.The procedure went as planned with no change in equipment.Standard exchange wire was used.No balloon sizing was performed and the 30 mm gore® cardioform septal occluder was deployed with normal appearance.The bubble test revealed that the psg was closed.The tamponade was not evident during post closure echography.There were no haemodynamic changes noted during the procedure.Twenty minutes after leaving the catheter laboratory the patient felt slight discomfort.Blood pressure, puls and sonics all fine.The patient went up to ward.Twenty minutes later the patient suffered from tachycardia.The blood pressure felt and the patient was very pale.The patient was taken straight to theatre and an epicardial drain was inserted.A 400 ml blood was being drained.The patient was monitored with drain insitu for 3 days.Only minor amounts of serous fluid was drained.The drainage was removed and the patient was discharged to home.The patient is taking dual anti platelet therapy.The patient will be reviewed on (b)(6) 2018 with an echocardiography.

Manufacturer Narrative

Imaging evaluation code 22: according to gore® cardioform septal occluder the instructions for use, adverse events associated with the use of the occluder may include, but are not limited to:significant pleural or pericardial effusion requiring drainage and pericardial tamponade.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7734286
• MDR Text Key: 115521961
• Report Number: 2017233-2018-00472
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: GSXE0030
• Device Lot Number: 17727304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 81