MAUDE Adverse Event Report: AGA MEDICAL CORPORATION 9VSDMPIIDE020 PKGD STERILE HDE; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-VSDMPIHDE-020
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 20mm amplatzer pi muscular vsd occluder was implanted.After the procedure, the device embolized and was snared and explanted on the same day.Per report, the patient's defect was too large for occlusion so the procedure was aborted.The user attributes patient anatomy to the cause of embolization.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of embolization was reported.The results of the investigation are inconclusive 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined; however, the user attributed the embolization to patient anatomy.
Event or Problem Description
On (b)(6) 2018, a 20mm amplatzer pi muscular vsd occluder was implanted.After the procedure, the device embolized and was snared and explanted on the same day.Per report, the patient's defect was too large for occlusion so the procedure was aborted.The user attributes patient anatomy to the cause of embolization.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of embolization was reported.The investigation confirmed the device met functional and dimensional 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 specifications at the time of commercialization.The cause of the reported incident could not be conclusively determined.

• Brand Name: 9VSDMPIIDE020 PKGD STERILE HDE
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8255809
• Report Number: 2135147-2019-00020
• Device Sequence Number: 19313642
• Product Code: MLV
• UDI-Device Identifier: 05415067028129
• UDI-Public: 05415067028129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2020

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: 02/28/2022
• Device Model Number: 9-VSDMPIHDE-020
• Device Catalogue Number: 9-VSDMPIHDE-020
• Device Lot Number: 5918979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 04/29/2019; 01/24/2020
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/30/2019; 02/17/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 72