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	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of migration 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.Based on the information received, the cause of the reported incident could not be conclusively determined; however per the physician the device may have been mis-sized for the patient's defect.
Event or Problem Description
On (b)(6) 2019, a 6/6mm amplatzer duct occluder ii (adoii/ 9-pda2-06-06) was deployed in the patent ductus arteriosus (pda) with no issues noted.On (b)(6) 2019, the deployed adoii was confirmed to be migrated toward the pulmonary artery side.The migrated adoii was retrieved immediately and percutaneously by using a 25mm snare catheter which was delivered through an 8f guiding catheter (type: jr4).The patient was monitored in stable condition postoperatively.Per physician, the adoii may have been mis-sized for the patient's pda.

• 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: 8513234
• Report Number: 2135147-2019-00112
• Device Sequence Number: 2817025
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

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: 09/30/2023
• Device Model Number: 9-PDA2-06-04
• Device Catalogue Number: 9-PDA2-06-04
• Device Lot Number: 6712311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 50