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

Model Number	9-ITV10F45/80
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Cardiac Tamponade (2226); Pericardial Effusion (3271); Unspecified Tissue Injury (4559)
Date of Event	04/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, an unknown size occluder was chosen for a postinfarct ventricular septal defect (pivsd) closure procedure using a 10f amplatzer torqvue delivery system.During procedure, the activated clotting levels were >250s and heparin was administered.When the delivery sheath was being advanced through the defect, a large pericardial effusion was seen and immediate loss of output.An emergency pericardial drain was inserted through a sub xiphoid approach (first pass) and cardiopulmonary resuscitation (cpr) was started.A large volume of blood was aspirated but there was no improvement in the hemodynamics and no reduction in the pericardial effusion was noted.There was continued and ongoing bleeding and no way of treating that.They mentioned it was due to myocardial rupture and no mechanical problem that they could fix, the whole team agreed that it was appropriate to stop cpr.The patient was reported passed away.The occluder was not opened and used.The physician thought the cause of death was ventricular rupture during a percutaneous attempt to close a post infarct ventricular septal rupture (vsd).
Additional Manufacturer Narrative
Na.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of use of device problem was reported.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 available information, the reported use of device related tissue damaged could not be determined.The cause of death was ventricular rupture during a percutaneous attempt to close a post infarct ventricular septal rupture (vsd).The patient effects of pericardial effusion and cardiac tamponade could not be conclusively determined.Bleeding appears to relate to pericardial effusion/tamponade, unable to treat, and subsequent cardiogenic shock (cardiac arrest).The reported unexpected medical interventions were a result of case-specific circumstances.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: 21919905
• Report Number: 2135147-2025-02223
• Device Sequence Number: 21103934
• Product Code: DQY
• UDI-Device Identifier: 00811806010878
• UDI-Public: (01)00811806010878(17)251031(10)8746380
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 10/31/2025
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Device Lot Number: 8746380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2022
• 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; Disability; Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female