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

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implanted and a device lot number was not provided from the facility.An investigation was unable to be performed and a cause of the reported event was unable to be determined.(b)(4).The indication/intended use section of the gore® cardioform septal occluder instructions for use note: the gore® cardioform septal occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (asds).

Event Description

It was reported the physician selected a gore cardioform septal occluder to occlude a pulmonary vein fistula on (b)(6) 2017.The device was deployed and locked.Following retrieval cord removal, it appeared some cord may still be attached to the device, but the echocardiographic imaging was inconclusive.The retrieval cord that was removed was measured and found to be twice the length of the catheter, but it looked frayed on the end.After the procedure, follow-up echocardiography confirmed a piece of cord was still attached to the device.On (b)(6) 2017, the physician removed the cord with a snare in a transcatheter procedure.The device remains implanted and the patient was doing well following the procedure.

• 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6896278
• MDR Text Key: 87446153
• Report Number: 2017233-2017-00501
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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): Hospitalization; Other