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

Model Number	9-VSD-MUSC-014
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Movement (3026)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device embolization was reported.The results of the investigation are inconclusive since the device remains in situ 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; however, the user attributed the cause of death to heart failure.
Event or Problem Description
On (b)(6) 2018, a 14mm amplatzer muscular vsd occluder was selected for a final attempt for closure of a prosthetic pvl in a patient with rv failure who was considered inoperable.Closure.During implant, the device appeared stable, however, some motion of the prosthetic valve was noted on toe.The implant was uneventful and on (b)(6) 2018, the patient was returned to their local hospital.Assessment at the location hospital on (b)(6) 2018, confirmed the device embolized into the left atrium.Due to patient clinical status, there was further intervention carried out.A few days following the transfer to the local hospital, the patient gradually declined due to heart failure and died.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7611724
• Report Number: 2135147-2018-00066
• Device Sequence Number: 1652218
• Product Code: MLV
• UDI-Device Identifier: 00811806011837
• UDI-Public: 00811806011837
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 9-VSD-MUSC-014
• Device Catalogue Number: 9-VSD-MUSC-014
• Device Lot Number: 6004785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2018
• Initial Report FDA Received Date: 06/18/2018
• 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