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

Model Number	ASD27A
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) # :p050006.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9480798
• Report Number: 2017233-2019-01250
• Device Sequence Number: 16489976
• Product Code: MLV
• UDI-Device Identifier: 00733132636488
• UDI-Public: 00733132636488
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14