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

Catalog Number GSX0025A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Result: the review of the manufacturing records verified that this lot met all pre-release specifications.The image review stated that the device discs are evenly deployed on the right and left atrial septum.The left atrial disc is flat.There is right disc expansion and an unlocked right atrial eyelet.The device remained implanted.Follow-up imaging displays a flat left disc and an expanded right disc.The patient will be seen again in follow-up on day eight post procedure.

Event Description

It was reported to gore a 25mm gore® cardioform septal occluder was selected to close an atrial septal defect.Right disc expansion was noted following deployment.Post procedure imaging showed the right atrial eyelet came off the lock loop.The device remains implanted and follow-up imaging indicates the expansion is decreasing.

• 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: 6015348
• MDR Text Key: 57449881
• Report Number: 2017233-2016-00785
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2018
• Device Catalogue Number: GSX0025A
• Device Lot Number: 15051875
• 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: 05/09/2016
• 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): Other
• Patient Age: 60 YR
• Patient Weight: 95