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

Model Number	9-PDA-007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 12/10mm amplatzer duct occluder was selected for implant.When the occluder was deployed, it came out in a balloon shape.The physician removed the occluder from the patient and redeployed the occluder outside the patient, but the issue persisted.A 12/10mm occlutech occluder was successfully implanted to complete the procedure.The procedure was extended by more than 30 minutes, but the patient was hemodynamically stable throughout the procedure and is reported stable.
Additional Manufacturer Narrative
The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met all functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7893323
• Report Number: 2135147-2018-00157
• Device Sequence Number: 16599099
• Product Code: MAE
• UDI-Device Identifier: 00811806011141
• UDI-Public: 00811806011141
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: 05/31/2022
• Device Model Number: 9-PDA-007
• Device Catalogue Number: 9-PDA-007
• Device Lot Number: 6016932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/14/2018
• 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: 9 YR