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

Catalog Number HX2035

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Date 03/28/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a 35 mm gore helex septal occluder to close a multi-fenestrated atrial septal defect.The anterior defect balloon sized to 12-14 mm, and the posterior defect balloon sized to less than 10 mm.The physician chose to place the device in the posterior defect.The device was deployed and locked.Images showed a minor anterior shunt, and the device was left in place.The evening following implant, the device embolized to the right pulmonary artery.The next day, transesophageal echocardiography showed the main defect measuring greater than 20 mm.The physician attempted transcatheter retrieval of the device.Attempts to snare the device were unsuccessful, and the patient was sent to surgery for device removal and defect closure with a patch.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

• 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3739545
• MDR Text Key: 4222737
• Report Number: 2017233-2014-00188
• 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: 03/28/2014

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: 01/31/2016
• Device Catalogue Number: HX2035
• Device Lot Number: 11150643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 79