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

Model Number	25-302
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/09/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices were 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.(b)(4) reference report 1317056-2025-00019- device 1 of 3.(b)(4) reference report 1317056-2025-00020- device 2 of 3.(b)(4) reference report 1317056-2025-00021- device 3 of 3.
Event or Problem Description
An angiodynamics senior territory manager reported that a patient expired during an off-label alphavac procedure.It was reported that the mass that was being removed had embolized to the lung, resulting in the patient's expiration.The following was reported from the tech who was scrubbed in for the procedure: "the patient was a 26-year-old male with advanced metastatic cancer and he had a tumor that was blocking his ivc/ra.He was terminal but this tumor was causing renal and liver failure and they wanted to improve his quality of life before he died.Dr.(b)(6) started out by trying to snare the tumor piece by piece with an ensnare and the ono device.Early in the procedure we saw on the echo how he had pulled off a big piece, but it fell out of the snare and we didn't know where i went.(b)(6) went on and was taking pieces of the tumor out.He switched from the snare to the alphavac at some point (22fr) and it worked okay.We had an issue with it at one point ((b)(4)) but i can't remember what happened with it which is why we opened another one.The patient started coding at one point and we opened the 18fr version ((b)(4)).The dilator wouldn't pass through the whole device as much as dr.Dave elison pushed.They got it to work at one point and the patient recovered (on rocket fuel though).Then later on anesthesia said he was having a pe so we took a pic of the pa (he only had an lpa as his right lung was removed) and 2/3 of it was blocked.Patient then started coding again.While patient was receiving cpr, we wanted to put the 18 alphavac up there but couldn't get the dilators to work.We opened a second one ((b)(4)).They basically had the same dilator problems but he just shoved it in i think and it didn't get anything out.Pretty sure we put the 22fr one up there too but i can't remember.All of them got nothing.Then we opened the penumbra indigo and it also got nothing.After a lot of cpr and the fact that he wasn't a candidate for advanced msc they called it.It was probably a big piece of the tumor that embolized and got lodged up there and wouldn't come out.It was a very high stress case.Basically, the physician had issues getting the dilators to go in.Also, the way the 22fr one is flared at the tip resulting in the physician having a had a hard time making it go in." despite good faith effort attempts, no further details have been provided.Device 2 of 3.
Additional Manufacturer Narrative
Correction: initial medwatch was inadvertently submitted under an incorrect mfr report number.The initial will be resubmitted under the correct mfr report number, 1319211-2025-00004.

• 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: 21341037
• Report Number: 1317056-2025-00020
• Device Sequence Number: 19795680
• Product Code: QEZ
• UDI-Device Identifier: H787253020
• UDI-Public: H787253020
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25-302
• Device Lot Number: 5828558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/09/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: 26 YR
• Patient Sex: Male