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

Model Number 9-VSDMPIHDE-020

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2018

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8255809
• MDR Text Key: 133351501
• Report Number: 2135147-2019-00020
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067028129
• UDI-Public: 05415067028129
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 04/29/2019; 01/24/2020
• Supplement Dates FDA Received: 04/30/2019; 02/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72