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

Catalog Number GSX0025A

Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.The occluder remains implanted.The retrieval cord and retrieval cord lock were returned to gore for analysis.The investigation revealed that there was a break in the cord consistent with the reported information.The rest of the delivery system was not returned for analysis.The cause of the retrieval cord break 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.(b)(4).

Event Description

It was reported the physician selected a gore cardioform septal occluder to close an atrial septal defect.The device was advanced, deployed, and locked.Upon retrieval cord removal, the physician noted resistance and the cord broke.It appeared both pieces of the retrieval cord were removed.While monitoring intracardiac echocardiography, a 1-2cm strand was seen hanging from the right atrial eyelet.The physician was able to snare the strand from the eyelet, but it then embolized and remains in the patient.The procedure was concluded and the patient was doing well afterwards.

• 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5145342
• MDR Text Key: 28567592
• Report Number: 2017233-2015-00696
• 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: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2017
• Device Catalogue Number: GSX0025A
• Device Lot Number: 14137102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 46 YR