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

Catalog Number GSX0030A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Respiratory Distress (2045)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.The imaging evaluation states that upon review of the fluoroscopic still image of the released device, it appears a portion of the left disc appears to be deployed on the right side of the septum, however this cannot be confirmed without echocardiographic images.Per the ifu a minimum occluder to defect size ratio of 1.75:1 is recommended.The defect size should be no greater than 17 mm.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to close an atrial septal defect with a mobile septum primum.The defect measured 17.6mm by intracardiac echocardiogram and 19mm by fluoroscopy.The device was deployed and locked and it was reported the physician felt the device was in good position.It was reported that later that day the patient experienced a coughing episode.An echocardiogram was performed and showed the device had embolized to the mitral valve.The patient was taken to surgery and the device was successfully removed and the defect closed.It was reported that during removal of the device it was observed that the anterior leaflet of the device had attached to a tendinae of the mitral valve, resulting in mitral valve stenosis and insufficiency.The patient was reported to be doing well and was discharged on (b)(6) 2017.

• 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 86005
• Manufacturer Contact: kathy titus ; 9285263030
• MDR Report Key: 6519793
• MDR Text Key: 73624663
• Report Number: 2017233-2017-00221
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2018
• Device Catalogue Number: GSX0030A
• Device Lot Number: 15648204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2016
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 7 YR
• Patient Weight: 25