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

Catalog Number GSX0030A

Device Problem Device Slipped (1584)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Results: a review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).The gore® cardioform septal occluder instructions for use list device embolization as a potential device or procedure-related adverse event.

Event Description

It was reported the physician selected a 30mm gore cardioform septal occluder to close a 13mm x 17mm atrial septal defect with a deficient anterior rim.The device was placed with confirmed capture of all rims, but a trivial anterior residual shunt was seen on color flow.The physician locked the device and the shunt appeared smaller.The device appeared stable and the retrieval cord was removed, following which, the occluder prolapsed into the right atrium and under the tricuspid valve.Valve function was not affected and the patient remained stable; however, the device was not amenable to percutaneous retrieval.The occluder was then surgically removed and the defect was closed with a patch.The patient was doing well following the procedure.

Manufacturer Narrative

Noted the device in unavailable for evaluation.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• 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: 6958068
• MDR Text Key: 89604307
• Report Number: 2017233-2017-00542
• 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,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 16336901
• 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: 05/24/2017
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 118