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

Model Number ASD27A

Device Problem Expulsion (2933)

Patient Problem No Code Available (3191)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # :p050006.

Event Description

It was reported the physician implanted a 27mm gore® cardioform asd occluder to close an atrial septal defect on (b)(6) 2019.The defect was not balloon sized.Transthoracic echocardiography on (b)(6) 2019 showed the device had embolized to the left pulmonary artery.The embolized device was removed by snare in a transcatheter procedure and a 32mm gore® cardioform asd occluder was implanted.The patient is currently stable and doing well.

Manufacturer Narrative

Additional case details: static defect measurement was 10mm; the patient had a deficient aortic rim (>5mm); there was a sufficient posterior rim (no measurements).The gore® cardioform asd occluder instructions for use list embolization as potential clinical and device adverse event.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9480798
• MDR Text Key: 185085934
• Report Number: 2017233-2019-01250
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636488
• UDI-Public: 00733132636488
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: ASD27A
• Device Catalogue Number: ASD27A
• Device Lot Number: 20858365
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14