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

Model Number 9-ASD-016

Device Problem Failure to Disconnect (2541)

Patient Problem Thrombus (2101)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 16mm amplatzer septal occluder (aso) was selected for implant using a 45/80mm 8f amplatzer delivery system.During implant, the user reported difficulty releasing the device from the delivery cable and elected to remove the device from the patient.The device was reported to be able to detach outside of the body and were attempted to re-connect.However, the physician observed thrombi adhered to the end screw of the aso and the delivery cable.Both devices were exchanged for another 16mm aso (lot number: 6855822) and 45/80mm 8f amplatzer delivery system (lot number: 6884845) and heparin was administered.The procedure was completed with no patient consequences reported.

Manufacturer Narrative

The reported event of difficulty releasing the device from the delivery cable in the patient and thrombus 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 and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined; however per the site the device was able to be detached from the delivery cable outside of the body.

Event Description

On (b)(6) 2019, a 16mm amplatzer septal occluder (aso) was selected for implant using a 45/80mm 8f amplatzer delivery system.During implant, the user reported difficulty releasing the device from the delivery cable and elected to remove the device from the patient.The device was reported to be able to detach outside of the body and were attempted to re-connect.However, the physician observed thrombi adhered to the end screw of the aso and the delivery cable.Both devices were exchanged for another 16mm aso (lot number: 6855822) and 45/80mm 8f amplatzer delivery system (lot number: 6884845) and heparin was administered.The procedure was completed with no patient consequences reported.

• 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: 8795480
• MDR Text Key: 151201181
• Report Number: 2135147-2019-00210
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: 00811806010137
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 6855822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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: 63 YR
• Patient Weight: 79