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

Model Number 9-ACP2-010-034

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, two different devices were chosen for procedure due to mis-sizing's (9-acp2-010-028 lot: 7228124 and 9-acp2-031 lot: 5613053) before the physician was able to successfully implant a 34mm amulet (9-acp2-010-034 lot: 5737757).Post procedure,the patient was brought to the icu.A few hours later, the patient was given a tte to rule out a pulmonary emboli.Imaging revealed the device had embolized into the left atrium.An interventional retrieval via snare was planned, but the patients esophagus had a hematoma related to the previous procedure so the tee probe could not be used.The physician did not want to attempt an intervention without the tee imaging and the patient was taken for surgical removal at a nearby hospital on friday, (b)(6) 2020.The device was removed and the patient is recovering.

• Brand Name: AMPLATZER AMULET
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10270980
• MDR Text Key: 198873315
• Report Number: 2135147-2020-00314
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806013527
• UDI-Public: 00811806013527
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 9-ACP2-010-034
• Device Lot Number: 5737757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention