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

Model Number 9-ASD-018

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Low Blood Pressure/ Hypotension (1914); Complete Heart Block (2627)

Event Date 01/15/2015

Event Type  Injury  

Event Description

The defect was sized using the stop-flow technique and an 18mm amplatzer septal occluder (aso) was deployed.Following a push-pull test, the aso was released from the cable.The patient developed complete heart block and hypotension after release.A dose of atropine and epinephrine were administered with improvement in both heart rate and blood pressure.A 10mm amplatz gooseneck snare within a 5f catheter was used to percutaneously retrieve the aso.The patient returned to normal sinus rhythm after device retrieval.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The 18mm aso was received in the product surveillance lab and decontaminated.The occluder was grossly and microscopically examined and no anomalies were noted on the occluder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of this investigation confirmed the aso met all functional specifications when analyzed at sjm.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: 4478549
• MDR Text Key: 5402463
• Report Number: 2135147-2015-00005
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 4282394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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
• Patient Age: 3 YR
• Patient Weight: 15