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

Model Number 9-VSD-MUSC-006

Device Problem Entrapment of Device (1212)

Patient Problem Pulmonary Edema (2020)

Event Date 07/31/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Model number -- the model number was an estimate due to the limited information provided.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Per report, during the (b)(6) 2013 procedure for a pediatric patient, a 6mm amplatzer vsd occluder caused left ventricular diastolic dysfunction which resulted in episodes of flash pulmonary edema at the time of extubation.An emergency surgical procedure was required and at that time, the device was found to entrap the free wall of the left ventricle and mitral valve apparatus.The occluder was removed surgically and the vsds were surgically closed.The child made an unremarkable recovery and remains well two years later, with normal left ventricular function.Attempts to obtain further information have been unsuccessful.

Manufacturer Narrative

(b)(4).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5273333
• MDR Text Key: 32892196
• Report Number: 2135147-2015-00146
• Device Sequence Number: 1
• Product Code: MLV
• 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,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: 9-VSD-MUSC-006
• Device Catalogue Number: 9-VSD-MUSC-006
• Device Lot Number: 1202298658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• 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
• Patient Age: 13 MO