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

Model Number	9-VSDMPIHDE-024
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Heart Failure (2206)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9908757
• Report Number: 2135147-2020-00141
• Device Sequence Number: 14277035
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: H070005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Life Threatening; Other
• Patient Age: 54 YR