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

Model Number	9-PDA2-05-06
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2020
Type of Reportable Event	Serious Injury
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, a 4-4 amplatzer duct occluder ii (4-4adoii, lot#: unknown) was attempted to be implanted for a patient's pda closure.However, the 4-4 adoii size was not suited for the pda.A larger-sized 5-6 amplatzer duct occluder ii (5-6 adoii) was implanted instead.There was slight residual leak post-implant, but no aortic pressure gradient difference was confirmed, and so the implant procedure was completed.On (b)(6) 2020, however, the 5-6 adoii was reported to have dislodged, fell off to the pa side.The 5-6 adoii was removed from the patient using a 5f snare catheter and a new 6-6 amplatzer duct occluder ii was successfully implanted.No patient consequences were reported.No further information is available.
Additional Manufacturer Narrative
Additional information sections: h2, h6, h10 an event of residual shunt and device embolization was reported.A more comprehensive assessment could not be performed 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.Based on the information received, 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: 10025468
• Report Number: 2135147-2020-00159
• Device Sequence Number: 1265330
• Product Code: MAE
• UDI-Device Identifier: 00811806011240
• UDI-Public: 00811806011240
• 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: 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): 12/21/2020

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: 07/31/2023
• Device Model Number: 9-PDA2-05-06
• Device Catalogue Number: 9-PDA2-05-06
• Device Lot Number: 6571265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/22/2020; 11/10/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/29/2020; 12/21/2020
• 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: Hospitalization; Required Intervention