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

Catalog Number HX2035

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Information (3190)

Event Date 03/19/2014

Event Type  Injury  

Event Description

It was reported the physician was implanting a 35mm gore helex septal occluder to close an atrial septal defect (asd).With the first or second push of the left disc, the left disc appearance suggested a premature lock release had occurred.While removing the device, the left disc caught in the tricuspid valve.The left disc was removed from the tricuspid valve with some manipulation but then the left eyelet got caught in the papillary muscle of the tricuspid valve.The physician was not able to remove the device from the valve, so the patient was sent to surgery for device removal and asd closure.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The 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: 3728072
• MDR Text Key: 4328688
• Report Number: 2017233-2014-00179
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: HX2035
• Device Lot Number: 10461691
• 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: 07/16/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 61