MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER P.I. MUSCULAR VSD OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-VSDMUSCPI-020

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 20 mm amplatzer p.I.Muscular vsd occluder was implanted on (b)(6) 2018 for treatment of a post-infarct vsd.After the procedure, anesthesia was reversed and the patient was noted to be disorientated and aggressively moving around.It was then noted that the occluder had embolized into the left pulmonary artery.On (b)(6) 2018, the occluder was surgically removed from the left pulmonary artery and patch closure of the vsd was performed.On a pre-surgery, ct, the patient was noted to have a pericardial hematoma, and the surgeon was able to suture repair the lpa where the occluder had been sitting.The device was discarded at the hospital and will not be returned for analysis.The patient is reported to be stable.

• Brand Name: AMPLATZER P.I. MUSCULAR VSD OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7679455
• MDR Text Key: 113742456
• Report Number: 2135147-2018-00087
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/11/2018

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: 10/31/2021
• Device Model Number: 9-VSDMUSCPI-020
• Device Catalogue Number: 9-VSDMUSCPI-020
• Device Lot Number: 5722869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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