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

Model Number 9-ASD-016

Device Problems Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder (aso) and 7f amplatzer torqvue 45 delivery system were selected.During deployment, the device formed into a cobra shape and was difficult to resheath.A 9f amplatzer torqvue exchange system was used to remove the 16mm aso.A second 16mm aso was used to successfully complete the procedure.The patient did not any adverse consequences.Additional information has been requested.

Manufacturer Narrative

The reported event of deformity upon deployment and difficulty resheathing could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2018, a 16mm amplatzer septal occluder (aso) and 7f amplatzer torqvue 45 delivery system (dtv45) were selected.During deployment, the device formed into a cobra shape and was difficult to resheath.A 9f amplatzer torqvue exchange system (etv) was used to remove the 16mm aso.A second 16mm aso was deployed using the original dtv45 delivery cable through the 9f etv to successfully complete the procedure.Per report the procedure was extended by 36 minutes.The patient did not have any adverse consequences and was discharged the next day.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7932871
• MDR Text Key: 122620914
• Report Number: 2135147-2018-00171
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 6330307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 10/03/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• 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: 2 YR
• Patient Weight: 9