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

Model Number	9-VSD-MUSC-018
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Biocompatibility (2886)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of the device being missized, the patient going into vtach, low blood pressure, and patient death "days" later due to complications of a myocardial infarction was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2020, the physician attempted to close a ventricular septal defect with a 9-vsd-musc-014 lot # 6243914 but the device prolapsed through the defect.It was mis-sized, never released and removed from the patient¿s body.The physician then decided to try a larger size, a 9-vsd-musc-018 lot # 6119716 but this device also slipped through the defect and was mis-sized.The physician re-sheathed the 18mm device and removed it from the patient.During the procedure the patient became unstable.The patient experienced vtach twice and also had to be temporarily paced.The patient's blood pressure dropped very low.The patient was sent back to icu while the cardiology team discussed next steps for the patient.The patient died days later.The physician does not attribute the death to the procedure or the device.The patient was very ill and the physician states the cause of death was due to complications of a myocardial infarction.

• 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: 9875863
• Report Number: 2135147-2020-00106
• Device Sequence Number: 11482609
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: 00811806011851
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• 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
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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: 07/31/2022
• Device Model Number: 9-VSD-MUSC-018
• Device Catalogue Number: 9-VSD-MUSC-018
• Device Lot Number: 6119716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/24/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR