MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA2-06-06

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Embolism (1829); Foreign Body Embolism (4439)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 6/6 amplatzer duct occluder ii was selected based on measurements of the ductal anatomy for implant in the patient.During the procedure the device was positioned, released from the delivery cable and then embolized into the patient's pulmonary trunk.The device was retrieved using a merit medical snare.The patient did not experience any serious injuries and a 6mm amplatzer duct occluder(ado) was used in replacement since the ductus was too lax.The ado device was successfully implanted in the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient is currently stable.

Manufacturer Narrative

An event of the device embolizing into the patient's pulmonary trunk was reported.The investigation confirmed the device met dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10924745
• MDR Text Key: 218915740
• Report Number: 2135147-2020-00512
• Device Sequence Number: 1
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (y/n): N
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PDA2-06-06
• Device Catalogue Number: 9-PDA2-06-06
• Device Lot Number: 7117402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 59