MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ALPHAVAC; ASPIRATION THROMBECTOMY CATHETER

Model Number	H787253020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762)
Date of Event	05/07/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer's reported complaint description of the patient decompensated [cardiac issues] and expired after removal of the alphavac cannula/sheath and gore dryseal sheath cannot be confirmed given the patient centric nature of this serious adverse event.No alphavac product was returned to angiodynamics for evaluation since there was no report of device malfunction or performance issue during use in the procedure.The device history record (dhr) review of the packaging/cannula/sheath lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The physicians stated they do not believe that any angiodynamics' device contributed, in any way, to the patient's expiration.There was no report of alphavac device malfunction or use error during the procedure and patient expiration is potentially due to their co-morbidities.Pulmonary embolism, cardiac arrest and death are listed in the device directions for use (dfu) as possible complications/adverse events due to use of embolectomy system.Labeling review: directions for use (10903689) is provided with this device and contains the following statements: indications for use the cannula is indicated for: the non-surgical removal of thrombi or emboli from the venous vasculature.Aspiration of contrast media and other fluids from the venous vasculature.The cannula is intended for use in the venous system and for the treatment of pulmonary embolism.Intended use: the alphavac system is intended to be used with commonly available vascular access tools (e.G., guidewire, vascular introducer, etc.) to facilitate the removal of thromboemboli, but not limited to, thrombus, embolus, or clot during minimally invasive percutaneous procedures.Warnings: selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians' sole responsibility.The outcome is dependent on many variables including, patient pathology, surgical procedure, and procedure/technique.The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.Adverse events: this device, as do all embolectomy systems and devices, has possible side effects, which include, but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the directions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, and application of intravascular introducer systems which include but are not limited to: arrhythmias, cardiac arrest, death, distal embolization of thrombus, pulmonary embolism, tachycardia.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint continues to be monitored for trends.Reference (b)(4).
Event or Problem Description
An angiodynamics territory manager (tm) reported that a patient, with several comorbidities, expired during a pulmonary embolism (pe) removal procedure, after use of an alphavac multipurpose mechanical aspirator f18 c85.The procedure was performd in accordance with the device's ifu and all appeared normal according to the physicians; however, the alphavac was removed to inspect if the cannula or sheath were obstructed; neither were, so the gore dryseal was removed.After removal of the dryseal, the patient's pressures began to drop and they decompensated [cardiac issue].At this time, an acls protocol was activated.The physicians checked the patient for a pleural effusion, pericardial effusion and hematoma; however, none were found.After several resuscitation attempts, the patient ultimately expired.This procedure was the first alphavac procedure for both attending physicians; however, one of the attendings is a regular angiovac user.The physicians do not believe that any angiodynamics device contributed, in any way, to the patient's expiration.

• Brand Name: ALPHAVAC
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 22080369
• Report Number: 1319211-2025-00025
• Device Sequence Number: 8702965
• Product Code: QEZ
• UDI-Device Identifier: 15051684025966
• UDI-Public: 15051684025966
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K240397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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 Model Number: H787253020
• Device Catalogue Number: 25-302
• Device Lot Number: 5827328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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 Sex: Male