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

Model Number 9-ASD-034

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 34mm amplatzer septal occluder was implanted.After release, the device did not appear positioned correctly in the septum.The user attempted to snare and remove the device to no success.As the attempt was unsuccessful, the procedure was aborted and the patient was taken to surgery where the device was removed and the septal defect was closed.Post-operatively, the patient is reported to be stable.

Manufacturer Narrative

It was reported that "the device did not appear positioned correctly in the septum" and could not be removed via snare.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 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.Please note, per the instructions for use (b)(4) rev b, "do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure (such as svc, pv, mv, cs, ao).".

Event Description

On (b)(6) 2019, a 34mm amplatzer septal occluder was selected after sizing the defect per the ifu, measurements 32mm.The device was deployed and after release, the device did not appear positioned correctly in the septum.The user reported the left atrial disc on the posterior side of the limbus was released on the right atrial side and no residual shunt remained.As the user was concerned about device embolization, the user attempted to snare and remove the device to no success.As the attempt was unsuccessful, the procedure was aborted and the patient was taken to surgery where the device was removed and the septal defect was closed.Post-operatively, the patient is reported to be stable.

• 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: 8465844
• MDR Text Key: 140347048
• Report Number: 2135147-2019-00089
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019356
• UDI-Public: 05415067019356
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 9-ASD-034
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 5316291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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: 62 YR