MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA-004

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of the occluder deploying malformed could not be confirmed.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a amplatzer duct occluder (9-pda-004) was selected for patent ductus arteriosus closure.During the procedure the device would not form correctly in the patient.The device retention skirt appeared malformed when deployed.The device was removed from the patient and an alternative device was used.The patient did not experience an serious injuries, the patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient is currently stable.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11077292
• MDR Text Key: 223772326
• Report Number: 2135147-2020-00556
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011110
• UDI-Public: 00811806011110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PDA-004
• Device Catalogue Number: 9-PDA-004
• Device Lot Number: 7538189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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): Required Intervention