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

Model Number 9-VSD-MUSC-012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

An event of the device having an unstable position, the defect being larger after the occluder was deployed and removed, hypotension and tachycardia 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.

Event Description

On (b)(6) 2019, a 12 mm amplatzer muscular vsd occluder was selected for a postinfarct vsd closure.The device was deployed in the vsd, but due to an unstable position it was recaptured/redeployed; it was aligned horizontally and not in-line with the septum.After recapturing the device, the defect was larger than prior to the procedure.The patient became hypotensive and tachycardic, ecmo therapy was initiated, and the patient was sent to cardiac surgery for vsd closure.The defect was successfully closed with a patch.The patient is in the icu and remains on ecmo support.The user indicated that this was a complicated surgery due to the unstable tissue (post-ischemic, post-infarct) of the defect.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9367463
• MDR Text Key: 167775686
• Report Number: 2135147-2019-00407
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011820
• UDI-Public: 00811806011820
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 9-VSD-MUSC-012
• Device Catalogue Number: 9-VSD-MUSC-012
• Device Lot Number: 5097362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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): Required Intervention