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

Catalog Number HX2035

Device Problem Difficult to Remove (1528)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a gore helex septal occluder on b)(6) 2013 to close an atrial septal defect.On (b)(6) 2014, the device was discovered to be embolized to the iliac bifurcation.In a transcatheter procedure a snare was used to try to remove the device but the device was endothelialized to the wall of the aorta.Since the device was not obstructing blood flow the physician decided to leave it in place.The atrial septal defect is scheduled to be surgically closed.The patient was doing well following the procedure.

Manufacturer Narrative

The review of the manufacturing records verified that this 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: dan kitterman ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3684052
• MDR Text Key: 4292586
• Report Number: 2017233-2014-00139
• 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
• Report Date: 02/21/2014

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: 10/31/2013
• Device Catalogue Number: HX2035
• Device Lot Number: 8573232A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2012
• 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
• Treatment: HEPARIN - B)(6) 2013
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 80