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

Catalog Number HX1535

Device Problem Difficult to Remove (1528)

Patient Problem Embolism (1829)

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records are in progress.

Event Description

It was reported the physician implanted a 35mm gore® helex® septal occluder on (b)(6) 2010 to close an atrial septal defect.The device was imaged on (b)(6) 2015 and it was discovered that the device embolized to the aorta.Percutaneous removal was attempted with a snare on (b)(6) 2015.Attempts to remove the device with a snare were unsuccessful and the patient was sent for surgical removal of the device.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• Brand Name: GORE HELEX 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: kathy titus ; 9285263030
• MDR Report Key: 5173855
• MDR Text Key: 29204320
• Report Number: 2017233-2015-00727
• 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: Initial,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: HX1535
• Device Lot Number: 7041308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2009
• 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
• Patient Age: 58 YR
• Patient Weight: 94