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

Model Number	9-ASD-013
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of deformity upon deployment could not be confirmed.The results of the investigation are inconclusive since the device was discarded at the hospital and was therefore not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined. .
Event or Problem Description
On (b)(6) 2018, two 13mm amplatzer septal occluders (aso) were selected for use.The event happened during the procedure.When a 13mm aso was delivered to and deployed in the left atrial, the left atrial disc of aso deformed into a cobra-head shape.The 13mm aso was once pulled back into the delivery sheath (model and lot unknown) and another attempt to deploy was made but the issue persisted.A second 13mm amplatzer septal occluder was deployed, but also had a deformation issue.The user elected to abort the procedure.The patient did not experience any adverse consequences.Another percutaneous closure procedure will be planned in 2019.Patient specific information of patient identifier, age or birthdate, gender, and weight are not available for this complaint.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8208752
• Report Number: 2135147-2018-00257
• Device Sequence Number: 1656407
• Product Code: MLV
• UDI-Device Identifier: 00811806010106
• UDI-Public: 00811806010106
• 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): 01/02/2019

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: 05/31/2020
• Device Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 5134259
• 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: 12/06/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: Hospitalization; Required Intervention