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

Model Number	25-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/14/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was disposed; therefore, it will not be returned to the manufacturer for physical evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An angiodynamics scientific and clinical affairs manager reported a patient expiration, occuring after use of an alphavac multipurpose mechanical aspiration 25f / c180.The following was reported: "patient scheduled for alphavac procedure for ra thrombus and pe.Precase plan included using f22180 for the ra thrombus and then exchanging for f1885 if choosing to proceed with the pe portion.At procedure start patient was sedated and intubated by anesthesia with vitals noted to be hr 120s, nibp 120s/70s.O2 sats 97%.Access was rfv with 26fr.Gore sheath with no appreciable issues.F22180 device was introduced into the ra over the amplatz ss wire and aspiration was attempted with tee guidance.Some material was engaged and removed with the device.Some material was then engaged and not able to be removed due to the size and density of the material.We attempted to remove the material with negative pressure lock on the device through the gore sheath.The material was removed from the heart but became trapped in the lower part of the ivc.The alphavac device was then removed and not re-inserted for the remainder of the procedure.Tee showed no material in the ra and live tee was maintained to assess this following.The gore sheath was exchanged for an inari sheath and cannula and aspiration was attempted again.This proved unsuccessful as well and the clotriever xl device was then introduced into the ivc to capture and remove the material.This was successful on the first pass with the material in the cava being removed and venogram now showed a clear ivc per the physician.Contrast injected moved rather slowly through the ivc and a small amount of air was noted in the ivc.They inserted the inari cannula again and aspirated this air.They chose to proceed with the pe part of the case using a balloon catheter to cross the tv and into the pa.Arteriogram was performed on the left pa and showed thrombus present.They chose to proceed with the inari device since it was already open and performed 2 aspiration attempts with no material removed on inspection.The patient's blood pressure (nibp) was now noted to be lower at 70s/50s.They paused the procedure and attempted to reassess the blood pressure but were unable to obtain a new one.Patient's heart rate had also declined to around 100 now.Unable to obtain a good blood pressure and with a declining hr into the 70s they began cpr.They were unable to resuscitate the patient and ultimately he expired.Post conference with physician, he was unable to pinpoint exactly what may have caused the event but did not believe our device's use at the beginning of the procedure had contributed to this.Product was not collected and returned due to no device failure being noted." the procedure was performed to the directions for use (dfu) and dr.Knapp has extensive interventional radiology experience.
Additional Manufacturer Narrative
The customer's reported complaint description of patient embolization and subsequent expiration cannot be confirmed given the patient centric nature of this serious adverse event (sae).There were no reports of alphavac device malfunction during the procedure; therefore, the device was not returned for evaluation.The physician reported they were unable to pinpoint exactly what may have caused the event but did not believe the alphavac device's use at the beginning of the procedure had contributed to the sae.A device history record (dhr) review of the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the directions for use (dfu) that is provided with this device 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.Directions for use and manuals for the alphavac system and all related accessories should be read prior to use and devices used as indicated.As with all medical devices, this device and ancillary equipment are to be used by trained physicians only.Specifically, this device is to be used only by medical personnel experienced with using surgical and/or percutaneous (seldinger) vascular access techniques as well as physicians trained and experienced in percutaneous, intravascular, diagnostic and interventional techniques requiring fluoroscopic or image guidance and visualization.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: distal embolization of thrombus.Pulmonary embolism.Cardiac arrest.Death.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).

• 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: 21356046
• Report Number: 1319211-2025-00002
• Device Sequence Number: 7741108
• Product Code: QEZ
• UDI-Device Identifier: H787253010
• UDI-Public: H787253010
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 25-301
• Device Lot Number: 5837047
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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: 76 YR
• Patient Sex: Male