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

Catalog Number GSXE0030

Device Problems Entrapment of Device (1212); Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore, a 30 mm gore® cardioform septal occluder was selected to close an atrial septal defect measuring 11 mm x 14 mm on transoesophageal echocardiogram (toe).No balloon sizing was performed.Deployment was without issue and the device locked; however, there was some question as to whether all the rims had been captured, specifically the posterior inferior rim, no color flow performed.Discussion took place and the decision was made to release the device.On release the device slipped through on the aortic rim, but was stable in the defect.A 14fr cook sheath and a 25 mm goose neck snare were opened, but the device embolized before the 14fr sheath could be put in.The device embolized to the mitral valve and the decision was made to take the patient to surgery for closure and device removal, as there was concern about removing the device while it was caught in the mitral valve.Patient was stable and moved straight to the theatre.When the device was visable it was observed that the device was free of the mitral valve but the locking loop had gotten hooked onto one of the leaflets of the mitral valve.The patient was removed from bypass and the defect was closed surgically without issue.Toe showed that the mitral valve was not damaged.

• 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: 6830958
• MDR Text Key: 83996683
• Report Number: 2017233-2017-00436
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2019
• Device Catalogue Number: GSXE0030
• Device Lot Number: 16225010
• 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: 04/21/2017
• 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: 41 YR
• Patient Weight: 74