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

Model Number 9-VSD-MUSC-018

Device Problems Inadequacy of Device Shape and/or Size (1583); Biocompatibility (2886)

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

Event Type  Injury  

Manufacturer Narrative

An event of the device being missized, the patient going into vtach, low blood pressure, and patient death "days" later due to complications of a myocardial infarction 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, the physician attempted to close a ventricular septal defect with a 9-vsd-musc-014 lot # 6243914 but the device prolapsed through the defect.It was mis-sized, never released and removed from the patient¿s body.The physician then decided to try a larger size, a 9-vsd-musc-018 lot # 6119716 but this device also slipped through the defect and was mis-sized.The physician re-sheathed the 18mm device and removed it from the patient.During the procedure the patient became unstable.The patient experienced vtach twice and also had to be temporarily paced.The patient's blood pressure dropped very low.The patient was sent back to icu while the cardiology team discussed next steps for the patient.The patient died days later.The physician does not attribute the death to the procedure or the device.The patient was very ill and the physician states the cause of death was due to complications of a myocardial infarction.

• 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: 9875863
• MDR Text Key: 184828195
• Report Number: 2135147-2020-00106
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040040
• 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
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 9-VSD-MUSC-018
• Device Catalogue Number: 9-VSD-MUSC-018
• Device Lot Number: 6119716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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: 62 YR