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

Model Number 9-ASD-014

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the patient was treated for an atrial septal defect (asd).A 24mm sizing balloon was used to size the asd and measured it at 13.75mm.A 14mm amplatzer septal occluder was deployed but a residual shunt was detected.The physician believed the shunt would seal once the occluder was released from the delivery cable, so the device was released.After an echocardiogram it was determined the shunt was too impressive to leave untreated, so a 25mm amplatzer gooseneck snare was used to retrieve the occluder into a 12fr delivery system successfully.A 16mm amplatzer septal occluder was then successfully deployed and released with no residual shunt confirmed.

Manufacturer Narrative

An event of a residual shunt was reported.The investigation confirmed the device met functional and dimensional 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 incident could not be conclusively determined; however, a larger 16mm amplatzer septal occluder was implanted.

• 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: 8210438
• MDR Text Key: 131890168
• Report Number: 2135147-2018-00250
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: 00811806010113
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 9-ASD-014
• Device Catalogue Number: 9-ASD-014
• Device Lot Number: 6112534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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