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

Model Number 9-ASD-020

Device Problems Difficult or Delayed Positioning (1157); Retraction Problem (1536); Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problems Pulmonary Embolism (1498); Aneurysm (1708)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An atrial septal defect (asd) was balloon-sized to 19mm, and a 20mm amplatzer septal occluder (aso) was selected and properly attached to the delivery cable.The patient also had an atrial septal aneurysm, which made the angle of deployment difficult.The initial attempts to place the aso using a 9f amplatzer torqvue 45 delivery system (dtv45) sheath from the right groin were unsuccessful.An 8.5f sl1 sheath was then selected for use, and while the angulation was slightly improved, the aso was still unable to be placed.After the second attempt, the aso prematurely detached from the delivery cable and embolized to the pulmonary artery.The sl1 sheath was exchanged for a 12f dtv45 and positioned in the pulmonary artery.A 30mm gooseneck snare was used in an attempt to retrieve the aso.While the aso was snared successfully around the waist, it was unable to be re-sheathed.A 10f dtv45 was then introduced into the left groin and positioned in the pulmonary artery and a 10mm gooseneck snare was introduced through the 10f dtv45 and the right atrial pin was successfully snared.Per report, the aso was unable to be retracted as the snare released from the pin and the decision was then made to approach the aso from the ivc using a 30mm snare.The aso was retracted into the ivc; however control of the aso was not possible, and the aso embolized to the pulmonary artery for the second time.The patient was referred to surgery where the aso was removed and surgical closure of the asd was performed.The patient is reported to be doing well post-operatively.

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.

• 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: 5628461
• MDR Text Key: 44335425
• Report Number: 2135147-2016-00051
• 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: 04/07/2016

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: 12/31/2018
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 4507487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• 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: 44 YR
• Patient Weight: 197