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

Model Number 9-VSD-MUSC-018

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemolysis (1886); Renal Failure (2041); Hemolytic Anemia (2279)

Event Date 11/11/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, an 18mm amplatzer muscular vsd occluder was implanted.After implant, the patient presented with hemolysis, worsening renal function, and anemia.On (b)(6) 2018, the device was explanted, and following explant, the patient's hemolysis resolved.The patient is reported to be stable.The physician suspected the event was due to the implanted device as the hemolysis was clinically apparent roughly 2 days following occluder implant.The anemia was a marker of hemolytic activity progression until explant of device.After the device was explanted, the patient stabilized and indicators of hemolysis resolved.The patient did not a history of hemolysis, renal failure or anemia and baseline parameters at admission were normal.

Manufacturer Narrative

An event of renal failure and hemolysis was reported.The braiding of the occluder was bent and folded in on itself when received at abbott.How or when this damage occurred remains unknown; however it was consistent with damage incurred at explant.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.However, if the device was implanted in a damaged state, there would be an increased risk of hemolysis due to the condition of the device.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8177070
• MDR Text Key: 130763723
• Report Number: 2135147-2018-00239
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040040
• 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,Followup
• Report Date: 01/15/2019

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: 02/28/2022
• Device Model Number: 9-VSD-MUSC-018
• Device Catalogue Number: 9-VSD-MUSC-018
• Device Lot Number: 5899224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2017
• 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