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

Model Number 9-ASD-012

Device Problem Retraction Problem (1536)

Patient Problem Thrombosis (2100)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A 12 mm amplatzer septal occluder (aso) was deployed with a 7f amplatzer torqvue delivery system but upon deployment of both discs, the implant position was determined to not be stable.Upon withdrawal attempt, the aso could not be retracted back into the sheath.The sheath was replaced with a mullins delivery sheath and the aso was successfully withdrawn.The case was abandoned.On (b)(6) 2017, per report, the patient has swelling of the leg and deep vein thrombosis was suspected.The patient was treated with clexane.

Manufacturer Narrative

The results of this investigation confirmed the 12 mm amplatzer septal occluder met all functional and dimensional specifications when analyzed at abbott.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: 6394820
• MDR Text Key: 69620029
• Report Number: 2135147-2017-00034
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 5616482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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
• Treatment: MODEL: 9-ITV07F45/80, LOT: 5610854
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 MO
• Patient Weight: 10