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

Catalog Number GSX0030A

Device Problems Positioning Failure (1158); Positioning Problem (3009)

Patient Problem Pericardial Effusion (3271)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Evaluations of the device and images from the procedure are currently in progress.(b)(4).

Event Description

It was reported the physician was implanting a gore cardioform septal occluder to close a patent foramen ovale.The device was deployed with part of the left disc of the device in the tunnel of the defect.The device was retrieved and redeployed.The physician was unable to lock the device.The slider was not in the correct position, the physician recaptured the device with the retrieval luer.At this point in the procedure the physician realized the patient had a pericardial effusion.The physician performed a pericardiocentesis.The patient recovered and a new gore cardioform septal occluder was successfully deployed to close the defect.The patient was doing well following the procedure.

Manufacturer Narrative

The engineering investigation stated the lock release shuttle was in the unlocked position, the control shuttle was in the deployed position, and the occluder was attached to the delivery system by the retrieval cord when received by gore.The delivery catheter was separated from the delivery system at the luer.Analysis of the sliding components could not be done due to the state of the device as received.The physician reported that the slider was not in the correct position and was unable to lock the device.The ifu states that ¿failure to move the slider completely to the left and down position may prevent occluder locking¿.Based on inspection of this device, there is no indication that the reported event was due to the design or manufacture of the device.

Manufacturer Narrative

Fluoroscopic and echocardiographic images were received in flagstaff for review, and an imaging evaluation was conducted.A gore cardioform septal occluder appears to be deployed near the tunnel of the patent foramen ovale.Per fluoroscopy, the septal occluder forms inappropriately.There are no films displaying balloon sizing in order to depict where the atrial septum and tunnel are located in relation to the septal occluder.Per echo, a septal occluder is then viewed fully released.A fluoroscopic film displays an evenly deployed and properly locked device with a pericardial drain following pericardiocentesis.

Manufacturer Narrative

Additional information: b2: required intervention to prevent permanent impairment/damage.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5127118
• MDR Text Key: 27453051
• Report Number: 2017233-2015-00673
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 01/26/2016

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: 07/26/2017
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14116736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2015; 01/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 84 KG