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

Model Number 9-ASD-020

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

Patient Problem Arrhythmia (1721)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During the procedure, a 20 mm amplatzer septal occluder (aso) was implanted and released from the cable; however, the patient went into heart block therefore the 20 mm aso was snared and removed.The physician was optimistic that down-sizing the device would be less irritating to the patient's conduction system and an 18 mm aso was deployed; however, heart block returned.With the 18 mm aso still on the delivery cable, the 18 mm aso was removed.No additional treatment was required as a result of the heart block.The patient will be referred for surgical repair at a later date.

Manufacturer Narrative

Udi: (b)(4).The results of this investigation confirmed the 20mm amplatzer septal occluder met all functional and dimensional specifications when analyzed at sjm.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the reported event remains unknown.

• 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: 6259824
• MDR Text Key: 65050513
• Report Number: 2135147-2017-00006
• Device Sequence Number: 1
• Product Code: MLV
• 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: 12/21/2016

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: Physician
• Device Expiration Date: 08/31/2021
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 5635372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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): Required Intervention