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

Model Number	9-PDA2-06-06
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body Embolism (4439)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10924745
• Report Number: 2135147-2020-00512
• Device Sequence Number: 959915
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: 00811806011264
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• 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
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 59