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

Model Number	9-ITV09F180/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/10/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, an unknown amplatzer septal occluder was chosen for implant using a 9f amplatzer torqvue delivery system during a high-risk post-infarction ventricular septal defect (pivsd) closure procedure in a patient who was in cardiogenic shock secondary to post-mi vsd.The patient had been on therapeutic lmwh prior to the procedure, and during the procedure was receiving iv heparin, with an activated clotting time of 300 seconds.The patient was in sinus rhythm at the time of the procedure.No transseptal puncture was performed.A 9f amplatzer torqvue delivery system was selected for the intervention.As the delivery sheath was advanced across the apical vsd, the septal tissue appeared extremely fragile, consistent with friable myocardium following myocardial infarction.The procedure team reported no difficulty with device manipulation, and there were no allegations of device malfunction against the torqvue system or the amplatzer septal occluder.The user also confirmed that no abbott device was believed to have caused the pericardial effusion.During advancement of the sheath, the toe imaging team experienced difficulty obtaining a clear visualization of the sheath¿s position.While awaiting improved imaging, early signs of pericardial effusion were detected.No effusion had been present prior to the procedure.The effusion progressed to a circumferential distribution with a largest dimension of 2 cm.The user believed the effusion was caused by torqvue guide introduction across the apical vsd in the setting of friable myocardial tissue.As the effusion expanded, the patient developed signs of pericardial tamponade.Protamine was administered in response.Pericardiocentesis was performed; however, during this period, the patient suffered a cardiac arrest.Resuscitation efforts were unsuccessful, and the patient subsequently passed away.The cause of death was reported as pericardial tamponade, which the implanter classified as definitely related to the patient¿s comorbidities, noting that an implant had not been performed and therefore no device contributed to the outcome.
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 patient effects of pericardial effusion, cardiac tamponade, cardiac arrest, and patient death were reported.Information from the field indicated that the cause is related to underlying medical condition and procedure related.Not related to a device malfunction.A returned device assessment could not be performed as the device was not returned for analysis.Furthermore, this complaint was reviewed by medical affairs.The reviewer stated that, "the cause of death is related to the underlying patient comorbidity of a post-infarct myocardial infarction with friable myocardium in combination with procedure related myocardial injury due to instrumentation.Passage of the delivery catheter may have interacted with the apical myocardium and caused the apex to become injured.However, this cannot be confirmed for certain without an autopsy.Related to underlying medical condition and procedure related.Not related to a device malfunction." based on the available information, the cause for the reported cardiac arrest, and patient death is due to pericardial tamponade, however this could not be determined.The cause of the reported pericardial effusion could not be conclusively determined.An unexpected medical intervention was a result of case-specific circumstances, as a pericardiocentesis and cpr were performed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2026, an unknown amplatzer septal occluder was chosen for implant using a 9f amplatzer torqvue delivery system during a high-risk post-infarction ventricular septal defect (pivsd) closure procedure in a patient who was in cardiogenic shock secondary to post-mi vsd.The patient had been on therapeutic lmwh prior to the procedure, and during the procedure was receiving iv heparin, with an activated clotting time of 300 seconds.The patient was in sinus rhythm at the time of the procedure.No transseptal puncture was performed.A 9f amplatzer torqvue delivery system was selected for the intervention.As the delivery sheath was advanced across the apical vsd, the septal tissue appeared extremely fragile, consistent with friable myocardium following myocardial infarction.The procedure team reported no difficulty with device manipulation, and there were no allegations of device malfunction against the torqvue system or the amplatzer septal occluder.The user also confirmed that no abbott device was believed to have caused the pericardial effusion.During advancement of the sheath, the toe imaging team experienced difficulty obtaining a clear visualization of the sheath's position.While awaiting improved imaging, early signs of pericardial effusion were detected.No effusion had been present prior to the procedure.The effusion progressed to a circumferential distribution with a largest dimension of 2 cm.The user believed the effusion was caused by torqvue guide introduction across the apical vsd in the setting of friable myocardial tissue.As the effusion expanded, the patient developed signs of pericardial tamponade.Protamine was administered in response.Pericardiocentesis was performed; however, during this period, the patient suffered a cardiac arrest.Resuscitation efforts were unsuccessful, and the patient subsequently passed away.The cause of death was reported as pericardial tamponade, which the implanter classified as definitely related to the patient's comorbidities, noting that an implant had not been performed and therefore no device contributed to the outcome.

• 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: 24536560
• Report Number: 2135147-2026-01442
• Device Sequence Number: 21075625
• Product Code: DQY
• UDI-Device Identifier: 00811806010854
• UDI-Public: (01)00811806010854(17)260228(10)8964326
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/22/2026

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: 02/28/2026
• Device Model Number: 9-ITV09F180/80
• Device Catalogue Number: 9-ITV09F180/80
• Device Lot Number: 8964326
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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: Disability; Required Intervention; Death
• Patient Age: 56 YR
• Patient Sex: Female