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

Model Number	9-VSD-MUSC-018
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemolysis (1886); Renal Failure (2041); Hemolytic Anemia (2279)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8177070
• Report Number: 2135147-2018-00239
• Device Sequence Number: 2179157
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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