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

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and therefore an engineering evaluation cannot be performed.A lot number was not provided and therefore a review of the manufacturing records cannot be performed.

Event Description

It was reported a patient with a three year old gore helex septal occluder implant had a large residual shunt and was symptomatic.The physician selected a 30mm gore cardioform septal occluder to close the shunt; however, he experienced difficulty obtaining optimal apposition and removed the device.A vascular plug was then implanted with no adverse effects.

• 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 ; 9285263030
• MDR Report Key: 5357030
• MDR Text Key: 35533427
• Report Number: 2017233-2016-00036
• 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: 12/21/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2016
• 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: 37 YR
• Patient Weight: 73