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

Lot Number 12519067

Device Problem Malposition of Device (2616)

Patient Problem Complete Heart Block (2627)

Event Date 07/15/2014

Event Type  Injury  

Event Description

It was reported the physician was implanting a gore® helex® septal occluder to close an atrial septal defect.After implanting the device the physician noted that the device looked like it was sitting on the tricuspid value, but chose to leave the device in place.Two hours post procedurally the patient experienced 3rd degree heart block.The patient was brought back to the catheter lab and the device was removed percutaneously with a snare.The patient remained in heart block and will be evaluated for surgical repair.

Manufacturer Narrative

A lot number has not been provided and therefore a review of the manufacturing records cannot be performed.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded, so no engineering investigation could be performed.

Manufacturer Narrative

Device lot number and date of expiration was not included in the previously submitted report.

• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3962076
• MDR Text Key: 4624485
• Report Number: 2017233-2014-00377
• 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,Followup
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Lot Number: 12519067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 5 YR
• Patient Weight: 16