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

Model Number	9-ASD-011
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Thrombus (2101); Intermenstrual Bleeding (2665)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, an 11mm amplatzer septal occluder(aso) was implanted in the patient's defect.Late in (b)(6) 2020, atypical genital bleeding occurred on the patient, and aspirin which had been prescribed to the patient for about three month was stopped.The cause of the bleeding was gynecologic malignant tumor, and chemotherapy was started on the patient.On (b)(6) 2020, contrast-enhanced ct was obtained on the patient, then a large thrombus was incidentally found on the la disk side of the aso.Dabigatran etexilate has continuously been prescribed on the patient, but the physician thought it was insufficient, and changed it to heparin iv.The patient's current state and the lot# are confirming.
Additional Manufacturer Narrative
An event of a thrombus on an amplatzer septal occluder was reported.A more comprehensive assessment could not be performed as the device remains implanted 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 SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10211636
• Report Number: 2135147-2020-00294
• Device Sequence Number: 2134308
• Product Code: MLV
• UDI-Device Identifier: 00811806010083
• UDI-Public: 00811806010083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 05/31/2024
• Device Model Number: 9-ASD-011
• Device Catalogue Number: 9-ASD-011
• Device Lot Number: 7034200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: Other; Required Intervention