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

Catalog Number GSX0025A

Device Problems Migration or Expulsion of Device (1395); Failure to Advance (2524)

Patient Problem No Code Available (3191)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a 25mm gore cardioform septal occluder was selected to close an atrial septal defect static measured 8mm and balloon sized to 11mm.The device was successfully implanted at which time a 15mm gore cardioform septal occluder was selected to close a second defect static measured to 5mm.Several attempts were made but the device could not be advanced through the defect.During attempts to implant the second device, the first device embolized to beneath the mitral valve.The patient was taken to surgery, the device was successfully removed and the defects repaired.The patient was doing well following surgical closure of the defects.

Manufacturer Narrative

The imaging evaluation states that the images provided for review were not of diagnostic value.Therefore a reason for the embolization of the gore cardioform septal occluder could not be ascertained.The engineering investigation revealed that the size and shape of the occluder and lock loop were unremarkable.The cause of the reported events cannot be determined from the evidence available.Based on inspection of this device, there is no indication that the reported event listed above was due to the design or manufacture of the device.

• Brand Name: GORE® CARDIOFORM 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: kathy titus ; 9285263030
• MDR Report Key: 5340296
• MDR Text Key: 34917021
• Report Number: 2017233-2016-00001
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2017
• Device Catalogue Number: GSX0025A
• Device Lot Number: 14458182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• 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: 11 YR
• Patient Weight: 70