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	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 6/4mm amplatzer duct occluder ii (adoii) was selected for implant.The ado ii was deployed in the defect and no leakage was observed.While releasing the device, the aorta side of the disc fell out towards the pulmonary artery.The device was retrieved using a 15mm gooseneck snare catheter.A 10/8mm amplatzer duct occluder was successfully deployed and the procedure was completed with no further issues reported.The patient is noted to be stable.
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 and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2019, a 6/4mm amplatzer duct occluder ii (adoii) was selected for implant.The ado ii was deployed in the defect and no leakage was observed.While releasing the device, the aorta side of the disc fell out towards the pulmonary artery.The device was retrieved using a 15mm gooseneck snare catheter.A 10/8mm amplatzer duct occluder was successfully deployed and the procedure was completed with no further issues reported.The patient is noted 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: 9247915
• Report Number: 2135147-2019-00339
• Device Sequence Number: 19454403
• 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
• Reporter Type: Manufacturer
• Report Source: foreign
• 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?: 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: 6699971
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 11/10/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/25/2019; 12/20/2020
• 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: 1 YR