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

Catalog Number HX2030

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/03/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a 30mm gore® helex® septal occluder to close an atrial septal defect.The asd was a 13-14mm anterior superior defect with a deficient aortic rim.The total septal length was 32-34mm.The device was placed in the defect but the right disc flared a little into the right atrium.The physician chose to leave the device overnight with the hope it would lay flatter with time.The next day the physician was concerned with the right disc obstructing inferior vena cava flow, so he decided to remove the occluder.The occluder was snared out of the patient in an additional intervascular procedure.The patient was doing well following the procedure.The defect will be surgically closed.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The explanted device was discarded at the hospital.

• 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: 3872832
• MDR Text Key: 4459821
• Report Number: 2017233-2014-00309
• 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: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: HX2030
• Device Lot Number: 12314900
• 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: 03/05/2014
• 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: (B)(6) 2014 - HEPARIN
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 28