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

Catalog Number HX2030

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a 30mm gore helex septal occluder to close an atrial septal defect on (b)(6) 2013.Approximately 6 months post implant the patient was noted to have had a transient ischemic attack and the device was surgically removed and the defect repaired.The explanting physician described a fracture of the device and that the left disc was not apposed to the septum but was hanging into the left atrium.The patient was doing well following the procedure.

Manufacturer Narrative

No patient weight is available.The review of the manufacturing records verified that this lot met all pre-release specifications.

Manufacturer Narrative

The image review stated that the physician implanted a 30mm gore® helex® septal occluder to close an atrial septal defect on (b)(6) 2013.Approximately 6 months post implant the patient was noted to have had a transient ischemic attack.Echocardiography images revealed the right and left discs were separated and were not apposed to the septum.The separation of the two discs demonstrated the occluder was no longer locked.The patient was sent to surgery to have the occluder removed and the septum repaired with a patch.After the procedure, transesophageal echocardiography was done and demonstrated the defect was closed.The patient was doing well following the procedure.

Manufacturer Narrative

The engineering investigation of the explanted occluder stated the following: the investigation revealed a fracture in the wire frame of the left disc and non-uniform tissue ingrowth in the vicinity of the frame fracture.These findings are consistent with the event description.Based on inspection of this device, there is no indication that the reported event listed above was due to design or manufacture of the device.

• 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: 3775942
• MDR Text Key: 4374766
• Report Number: 2017233-2014-00218
• 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,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: HX2030
• Device Lot Number: 11479366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2013
• 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: 17 YR