MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-038

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Nausea (1970)

Event Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A device was placed on 8/6.Upon post echo 24 hours later the device was in good position.On 8/11 the patient reported nausea and sweating and, self reported to the emergency room with reported symptom relief shortly after.On echo in the ed, the device was noted to be in the la.An attempt was made to retrieve the device transcatheter unsuccessfully.After discussion with the team the decision was made to anticoagulate the patient and go to the or for device removal and surgical closure in the coming days.The patient remained stable throughout the procedure and was admitted to the hospital awaiting surgery.

Event Description

On (b)(6) 2019, a 38mm amplatzer septal occluder was implanted.On (b)(6) 2019, the patient presented to the emergency room with complaints of nausea and sweating.An echocardiogram was performed which revealed the device had embolized to the la.The device was unsuccessfully retrieved via transcatheter.On (b)(6) 2019, the patient was transferred to the operating room where the device was surgically removed and the asd surgically repaired.The patient is reported to be stable.The user alleges the device embolization was likely due to the large size of the atrial septal defect.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8942903
• MDR Text Key: 155977363
• Report Number: 2135147-2019-00270
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010267
• UDI-Public: 00811806010267
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 9-ASD-038
• Device Catalogue Number: 9-ASD-038
• Device Lot Number: 4791270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2014
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 92