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

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2016

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.Only the year of the gore helex septal occluder implant date is known; therefore, (b)(6) 2010 was used to reflect the implant date.

Event Description

It was reported a 30mm gore helex septal occluder was implanted in 2010 to close a patent foramen ovale.A portion of the device had not endothelialized and a residual shunt remained.Although the patient was not symptomatic, the physician opted to close the shunt because it had been open for a long period of time.On (b)(6) 2016, a 25mm gore cardioform septal occluder was selected to close the shunt.The physician placed a catheter across the shunt, then exchanged it for a stiff guidewire.The 25mm gore cardioform septal occluder was advanced over the wire, but the tip of the delivery catheter appeared to get caught on the helex device.While rotating the delivery catheter in an attempt to maneuver the device across the septum, the catheter twisted and kinked at the rapid exchange port.The delivery system and guidewire were withdrawn together to the introducer sheath; however, the kinked catheter and guidewire could not be pulled completely through it.Subsequently, the introducer sheath, guidewire and the delivery system were removed together.A 12fr introducer sheath was then placed, and a second 25mm gore cardioform septal occluder was advanced through a 10fr long sheath and implanted with no adverse effects.The patient was doing well following the procedure.

Manufacturer Narrative

The street address of the initial reporter was incomplete on the initial medwatch.The following is the complete name and address for field e.Initial reporter - name and address: (b)(6).

• 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6015034
• MDR Text Key: 56929557
• Report Number: 2017233-2016-00784
• 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: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• 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: 68 YR
• Patient Weight: 99