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

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the lot # remains unknown.The device remains implanted so no engineering investigation could be performed.

Event Description

It was reported the physician implanted a 35mm gore® helex® septal occluder to close an 21mm atrial septal defect on an unknown date.On (b)(6) 2016 a re-intervention was performed to close a residual leak.A 20mm gore® cardioform septal occluder was advanced and deployed but removed for a significant residual leak.A 30mm gore® cardioform septal occluder was then advanced, deployed and locked.A small residual leak in the anterior plane was noted but the device was left in place and the patient was doing well following the procedure.

• 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 86005
• Manufacturer Contact: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5944930
• MDR Text Key: 54507550
• Report Number: 2017233-2016-00747
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 18 YR
• Patient Weight: 82