MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-013

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 16 mm amplatzer septal occluder (aso) was deployed using an 8f amplatzer torqvue 45 delivery system (dtv45) however; as the disc edge pressed the posterior wall of the aorta the device was removed.A 14 mm aso was then attempted to be deployed and per report once again, the disc edge pressed the posterior wall of the aorta, so it was removed.Next, a 13 mm aso was successfully implanted and the position was confirmed prior to release of the aso from the delivery cable.After release, the aso once again, appeared too close to the posterior wall of the aorta and the device was attempted to be removed percutaneously using a 9f dtv45 and a 10 mm gooseneck snare.During snaring, the aso became hung up at the distal tip of the 9f dtv45 sheath and was unable to be pulled into the delivery sheath.The 9f dtv45 and the gooseneck snare were removed from the patient without consequences and the 9f dtv45 was replaced with a 10f dtv45.The same gooseneck snare was delivered through the 10f dtv45 delivery sheath and after several attempts to retrieve the aso, the device embolized to the left ventricle.Surgical intervention was required for the retrieval of the aso and the defect was closed with a pericardial patch.The patient is reported to be in stable condition.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6072478
• MDR Text Key: 58988605
• Report Number: 2135147-2016-00105
• Device Sequence Number: 1
• Product Code: MLV
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2016

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: 12/31/2019
• Device Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 4949838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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: 19 YR
• Patient Weight: 27