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

Model Number	9-PDA2-06-04
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, an amplatzer duct occluder ii was selected for implant.On (b)(6) 2020, the device embolized into the left pulmonary artery.The device was retrieved and the patient was reported to be stable.
Additional Manufacturer Narrative
Additional information: b5, d10, h3, h6, h10.An event of device embolization was reported.The results of this investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2020, an amplatzer duct occluder ii was selected for implant.On (b)(6) 2020, the device embolized into the left pulmonary artery.The device was retrieved, and the patient underwent surgery to correct the issue.The patient was reported to be stable.
Additional Manufacturer Narrative
Correction information for d2 additional information for g4, g7, h2, h10.

• 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: 9823330
• Report Number: 2135147-2020-00084
• Device Sequence Number: 1047404
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 9-PDA2-06-04
• Device Catalogue Number: 9-PDA2-06-04
• Device Lot Number: 7126006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/10/2020; 11/10/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/16/2020; 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 11