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

Catalog Number GSXE0030B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Complete Heart Block (2627)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.Case images were received by gore for evaluation.Imaging shows that upon the locking step, the device and delivery system appear to move forward.The grey catheter moves superior to the right atrial eyelet following the locking loop release and formation.The right and left atrial discs appear to be properly formed and on their respective sides.Following removal of the delivery system and retrieval cord, the device appears to shift, changing the appearance of the left atrial disc.The transthoracic echocardiographic images received capture minimal frames/beats, yet the device in one view appears to have a rightward shift toward the right atrium.(b)(4).

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to close a multi-fenestrated atrial septal defect.Upon locking, the device appeared to move forward and the physician pulled back slightly on the delivery system to prevent prolapse, and the device remained stable.Following device locking, the patient went into complete heart block.After 10 minutes, the patient moved into first degree heart block.The following day, the patient was going in between first and second degree heart block.The patient is being treated with steroids, and the physician will consider device removal and surgical defect closure if the heart block does not resolve.Additional information notes the patient had 2 holters post discharge, the first showed 1st degree heart block and brief episodes of 2nd degree heart block; the holter from the week of (b)(6) 2018 showed sinus rhythm, 1st and 2nd degree heart block with some periods of complete heart block.The patient's cardiologist is concerned that she still has av node dysfunction and recommends surgical device removal.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7226047
• MDR Text Key: 98514832
• Report Number: 2017233-2018-00058
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Initial
• Report Date: 01/12/2018

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: 08/10/2019
• Device Catalogue Number: GSXE0030B
• Device Lot Number: 16589869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14