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

Model Number 9-VSDMPIHDE-024

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Heart Failure (2206)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 24mm amplatzer post infarct vsd occluder in a three day old myocardial infarction.The device was mis-sized too small and pulled through.The patient was put on extracorporeal membrane oxygenation.The defect is planned to be surgically fixed when a bypass surgery is performed on the patient.

Manufacturer Narrative

Additional information to b5.Correction to: b1, b2, h1, h2, and h10.Manufacturer report 2135147-2020-00141, should not have been reported as a medical device report (mdr) as the event is not reportable.Upon review, the amplatzer post infarct vsd occluder should not have been submitted as a medical device report (mdr).There is no indication that abbott product caused a serious injury.

Event Description

On (b)(6) 2020, a 24mm amplatzer post infarct vsd occluder in a three day old mi.The device was mis-sized too small and pulled through.The patient was put on extracorporeal membrane oxygenation (ecmo).There was no allegations to the device that caused the patient to be put on ecmo and no complications due to the procedure or device.The defect is planned to be surgically fixed when a bypass surgery is performed on the patient.

• Brand Name: AMPLATZER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9908757
• MDR Text Key: 185979538
• Report Number: 2135147-2020-00141
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (y/n): N
• PMA/PMN Number: H070005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

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: 04/30/2024
• Device Model Number: 9-VSDMPIHDE-024
• Device Catalogue Number: 9-VSDMPIHDE-024
• Device Lot Number: 6980608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 54 YR