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

Catalog Number HX2025

Device Problems Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Failure to Advance (2524)

Patient Problem Embolism (1829)

Event Date 02/26/2014

Event Type  Injury  

Event Description

It was reported the physician was implanting a gore helex septal occluder to close a multifenestrated atrial septal defect.Using balloon sizing, the superior defect measured 8mm.The spread from the superior defect to the multifenestrated central defect was 18-19mm.The physician chose to close the larger superior defect and then re-evaluate the central defect.A 25mm gore helex septal occluder was implanted in the superior defect with no issues.A 10fr.Helex catheter was too large to be advanced through the central multifenestrated defect, so a 7fr.Numed 20mm sizing balloon was used to get across the defect.While inflating the balloon as the defect was being stretched, the superior 25mm helex device embolized to the left pulmonary artery.Multiple snares and forceps were attempted to grab the flat device but the physician was unable to retrieve the occluder.The patient was sent for surgical closure, which went well.The patient was doing well the next day.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.

Manufacturer Narrative

A review of the fluoroscopy images stated the following: the patient had multiple defects that required closure.A 25mm gore helex septal occluder was first implanted with part of the left disc in the right side of the septum.The 25mm gore helex septal occluder remained stable at the time of implant.It was reported that during the balloon sizing of the second defect, the balloon may have stretched the septum and caused the 25mm gore helex septal occluder to dislodge from the septum and embolize to the right pulmonary artery branch.After several attempts were made to remove the embolized occluder from the right pulmonary artery branch, the physician decided to send the patient to surgery to have the occluder removed and the defect repaired.

• 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: 3683800
• MDR Text Key: 4288891
• Report Number: 2017233-2014-00140
• 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
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: HX2025
• Device Lot Number: 12031974
• 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: 12/03/2013
• 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) 2014
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 183