MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number	9-ASD-024
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2018, a 24mm amplatzer septal occluder was selected for implant.When the left disc was deployed in the left atrium, the disc deformed.The device was re-sheathed and deployed several times with the same result.The device was removed from the patient without complication.A second 24mm device was deployed in the left atrium but the left disc came out of the sheath deformed.The second 24mm device was removed and a 26mm amplatzer septal occluder was successfully implanted.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7800968
• Report Number: 2135147-2018-00108
• Device Sequence Number: 11239890
• Product Code: MLV
• UDI-Device Identifier: 05415067019301
• UDI-Public: 05415067019301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 05/31/2021
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Device Lot Number: 5551412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/21/2018
• 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