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

Catalog Number HX2035

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported the physician selected a 30mm gore helex septal occluder to close an atrial septal defect measuring 12mm with intracardiac echocardiography, and 15mm with fluoroscopy.During left disc deployment, imaging showed a structure in the left atrium that appeared to be a thick membrane.The physician had difficulty obtaining optimal left disc apposition due to the structure.The device was ultimately deployed and locked; however, following lock release, the device orientation was not ideal.The physician attempted to rotate the device and the occluder prolapsed into the right atrium.The device was removed with the retrieval cord and a 35mm gore helex septal occluder was implanted with satisfactory result.The day following implant, imaging revealed the device had embolized to the left pulmonary artery.The gore helex septal occluder was removed with a snare and a device from another manufacturer was implanted.The patient was doing well following the procedure.

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: 4303846
• MDR Text Key: 19402508
• Report Number: 2017233-2014-00642
• 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: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: HX2035
• Device Lot Number: 11044498
• 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: 01/31/2013
• 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: 28 YR
• Patient Weight: 73