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

Model Number 9-VSD-MUSC-016

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

Patient Problem Hemolysis (1886)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

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 abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A 12/10mm amplatzer duct occluder was selected for implant for the closure of a ventricular septal defect (vsd) but was too small and removed without being released from the delivery cable.Next, a 14mm amplatzer muscular vsd occluder (muscvsd) was selected for use, however it was too small.Finally, a 16mm muscvsd was successfully implanted.The patient developed hemolysis due to the high pressure flow across the muscvsd device and required surgical removal of the device and surgical closure of the vsd.In the opinion of the user, hemolysis is sometimes seen with device closure of vsds and is not considered a malfunction of the muscvsd.

Manufacturer Narrative

An event of "hemolysis due to the high pressure flow across the muscvsd device" was reported.Visual examination revealed no anomalies were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2017, a 12/10mm amplatzer duct occluder was selected for implant for the closure of a ventricular septal defect (vsd) but was too small and removed without being released from the delivery cable.Next, a 14mm amplatzer muscular vsd occluder (muscvsd) was selected for use, however it was too small.Finally, a 16mm muscvsd was successfully implanted.It was noted the next day that the patient had developed hemolysis due to the high pressure flow across the muscvsd device.The muscvsd was surgically removed and the vsd was closed on (b)(6) 2017.The patient had a follow-up appointment on (b)(6) 2017 and was doing well with no sequelae related to the device closure or removal.In the opinion of the user, hemolysis is sometimes seen with device closure of vsds and is not considered a malfunction of the muscvsd.

• 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 ; 6517565400
• MDR Report Key: 6951276
• MDR Text Key: 89370230
• Report Number: 2135147-2017-00132
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

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: 01/31/2022
• Device Model Number: 9-VSD-MUSC-016
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 5856537
• Other Device ID Number: 00811806011844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 09/19/2017; 10/26/2017
• Supplement Dates FDA Received: 10/18/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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: 10 YR
• Patient Weight: 35