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

Catalog Number GSX0025A

Device Problem Insufficient Information (3190)

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

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician selected a 25 mm gore® cardioform septal occluder to close a patent foramen ovale.A j-tip guidewire and multipurpose catheter were used to access the defect.The physician attempted to place the guidewire in the upper pulmonary vein, but was unable to access the vein so the wire remained in the left atrium for device introduction.The device was advanced and the left disc was deployed, but when it was pulled to the septum, the disc appeared constrained and was sitting high in the atrium.At this point, the patient said something didn't feel right.The disc was reloaded and redeployed, following which, the disc appeared normal and properly apposed the septum.The patient said again that something didn't feel right.The physician then fully deployed and released the device, and the patient was checked for a pericardial effusion using intracardiac echocardiography (ice).No effusion was detected and the delivery catheter and ice catheter were removed.At this point the patient's blood pressure and heart rated dropped.Transthoracic echocardiography was brought in to assess the patient and revealed a pericardial effusion.The effusion was drained and the patient was transferred to the intensive care unit where he was in stable condition.Two days following the procedure, it was reported the patient was doing well and would be discharged.

Manufacturer Narrative

Electronic files containing digital cine fluoroscopy runs were received for evaluation.Fluoroscopy images show the gore® cardioform septal occluder being deployed in the left atrium.It is unknown where the tip of the delivery catheter is as no echocardiographic images of this step were provided, and the wire has already been removed.Other images show the depth of the initial deployment relative to the position of the device within the septum; however, without echocardiographic imaging, it is not possible to determine the position of the initial deployment relative to other cardiac structures.Additional procedural fluoroscopic images show the attempts of placing the guidewire in the left upper pulmonary vein and eventually placing the wire in the left atrium for device introduction.Transthoracic echocardiography images provided confirm the pericardial effusion.

Manufacturer Narrative

Usage of device - corrected to 'initial use of device'.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7355365
• MDR Text Key: 102970650
• Report Number: 2017233-2018-00181
• 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,Followup
• Report Date: 04/17/2018

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: Health Professional
• Device Expiration Date: 12/13/2019
• Device Catalogue Number: GSX0025A
• Device Lot Number: 17550283
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2018; 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 78