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

Model Number 9-ASD-MF-030

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a 30mm amplatzer cribriform occluder was selected for a multi-fenestrated defect.The device was placed and deployed, but retracted and removed from the patient.The fenestrated defect was not in an ideal location for placement of the device due to being located too close to the coronary sinus and the physician could not cross the other fenestration.The procedure was cancelled and there were no adverse patient consequences reported.

Manufacturer Narrative

An event of "the occluder not sitting well due to patient anatomy" could not be confirmed.The investigation confirmed the device met visual and dimensional 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 incident could not be conclusively determined; however per the site the procedure was aborted due to patient anatomy, "the fenestrated defect was not in an ideal location for placement of the device due to being located too close to the coronary sinus and the physician could not cross the other fenestration".

• Brand Name: AMPLATZER CRIBRIFORM 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: 8659782
• MDR Text Key: 146700066
• Report Number: 2135147-2019-00143
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010304
• UDI-Public: 00811806010304
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

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: 02/28/2021
• Device Model Number: 9-ASD-MF-030
• Device Catalogue Number: 9-ASD-MF-030
• Device Lot Number: 5412695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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): Other