MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-MF-018
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of "the ra disk was not able to fully spread" was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, an 18 mm amplatzer cribriform occluder was selected for use.When the 18 mm aco was deployed at the atrial septal defect, the ra disk was not able to fully spread.The aco was replaced with the same size of aco and the procedure was completed without issue.No adverse consequences to the patient was reported.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9034816
• Report Number: 2135147-2019-00297
• Device Sequence Number: 1784647
• Product Code: MLV
• UDI-Device Identifier: 00811806010281
• UDI-Public: 00811806010281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: 01/31/2024
• Device Model Number: 9-ASD-MF-018
• Device Catalogue Number: 9-ASD-MF-018
• Device Lot Number: 6851254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/13/2019
• 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