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

Catalog Number GSXE0030B

Device Problem Insufficient Information (3190)

Patient Problem Complete Heart Block (2627)

Event Date 11/05/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician implanted a 30mm gore cardioform septal occluder to close an atrial septal defect.Following implant, the patient developed persistent first and second degree heart block.The physician stated the gore cardioform septal occluder was well positioned and stable; however, he indicated surgical removal of the device and repair of the defect may be necessary.The patient returned to normal sinus rhythm and surgery wasn't performed.The patient is in the hospital under observation and doing well.

Manufacturer Narrative

Patient update: it has been further reported the patient has been discharged from the hospital and remains in normal sinus rhythm.Echocardiographic images were returned for review.The images reveal an atrial septal defect with a 5mm aortic rim and a properly implanted gore cardioform septal occluder partially splaying the aorta.The cause of the reported heart block cannot be determined from the available imaging.

• 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: 5263684
• MDR Text Key: 32603071
• Report Number: 2017233-2015-00848
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2017
• Device Catalogue Number: GSXE0030B
• Device Lot Number: 13871699
• 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: 05/28/2015
• 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): Hospitalization
• Patient Age: 6 YR
• Patient Weight: 24