MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-MF-035
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of a round, bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications at the time of release to commercialization.Though the occluder was determined to meet functional specifications, the root cause of the deformation upon initial deployment is under further investigation.
Event or Problem Description
On (b)(6) 2019, a 35mm amplatzer cribriform occluder was selected for implant using a 10f delivery system (lot number: unknown).Upon deployment, the physician reported one of the disc to be bolus.The device was exchanged for another 35mm amplatzer cribriform occluder (lot number: unknown) and the same issue occurred.A 18mm sizing balloon was used to size the defect and a 22mm amplatzer septal occluder (lot number: 6087998) was used to complete the procedure.The patient is reported to be stable.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9339040
• Report Number: 2135147-2019-00350
• Device Sequence Number: 2104963
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 01/31/2024
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 6883461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• 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: Required Intervention