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

Catalog Number GSX0030A

Device Problem Malposition of Device (2616)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 10/28/2015

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 measured to 17.5mm on (b)(6) 2015.The device had captured all the surrounding rims and there was no evidence of uneven deployment or residual shunt.On (b)(6) 2015, the device was removed due to protrusion of the superior portion of the left atrial disc, which was creating an approximated 4-5mm residual shunt.Following device removal, the defect was measured to 9mm in the static bicaval view, and to 18-19mm with stop flow balloon sizing.An amplatzer septal occluder was then implanted with no adverse effects.

• 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: 5242653
• MDR Text Key: 31822934
• Report Number: 2017233-2015-00825
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2017
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14266461
• 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: 09/29/2015
• 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: 41 YR
• Patient Weight: 73