MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Catalog Number	9-ITV10F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/15/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on 15 february 2024, a 24mm amplatzer post-infarct muscular vsd occluder was chosen for a high risk ventricular septal defect (vsd) closure post myocardial infarction using a 10f amplatzer torqvue delivery system.The patient was in a cardiogenic shock before the beginning of the procedure and the ejection fraction was less than 20%.During procedure, the activated clotting levels was more than 250s and heparin was administrated.An amplatzer guidewire was used to introduce the amplatzer torque view by suing the arteriovenous (av) loop technic.During the manipulation of delivery system inside the right ventricle, the patients health declined.An echocardiogram (echo) highlighted a pericardial effusion in the posterior part of the heart and it lead to cardiac tamponade.The patient had very low pressure and massive heart compression.A pericardiocentesis was performed, and the occluder was implanted to optimize patient status but it was not possible to stabilize the patient.The patient passed away at the end of the procedure.The cause of death was cardiac arrest.The physician mentioned the death was not related to the implant device and it was due to the risk of a very difficult procedure with a very fragile patient.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of pericardial effusion lead to cardiac tamponade, cardiac arrest, hypotension, and death was reported.A returned device assessment could not be performed as 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.Information from the field indicated that the patient was in a cardiogenic shock before the beginning of the procedure and the ejection fraction was less than 20%.An amplatzer pi muscular vsd occluder was chosen for a high risk ventricular septal defect (vsd) closure post myocardial infarction using a 10f amplatzer torqvue delivery system.During procedure, the manipulation of delivery system inside the right ventricle, the patients health declined.An echocardiogram (echo) highlighted a pericardial effusion in the posterior part of the heart which led to cardiac tamponade.The patient had very low pressure and massive heart compression.A pericardiocentesis was performed, and the device was implanted to optimize patient status but it was not possible to stabilize the patient.The patient passed away at the end of the procedure.The cause of death was cardiac arrest.The physician mentioned the death was not related to the implant device and it was due to the risk of a very difficult procedure with a very fragile patient.Based on the information received, the cause of the reported incident appears to be related to procedural condition and patients conditions (heart attack).There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18876010
• Report Number: 2135147-2024-01066
• Device Sequence Number: 9069130
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: (01)00811806010878(17)250430(10)8496025
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: 04/30/2025
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 8496025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male