MAUDE Adverse Event Report: ANGIODYNAMICS ALPHAVAC; ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20

Model Number	25-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.An angiodynamics territory manager (tm) reported via a product evaluation survey, a patient adverse event occurred after treatment with an alphavac multipurpose mechanical aspiration f18-85 cannula.The patient was treated for a left atrial thrombus, removing approximately 95% of the thromboemboli, and no issues were noted during the procedure.However, approximately 2-3 hours after the procedure was completed, the patient suffered a stroke.At this time the patient is currently stable and improving.Follow up with the tm determined that the physician confirmed this was not, in anyway, a result of product malfunction but a complication of the procedure.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The product was not returned for evaluation since there was no report of alphavac malfunction during the procedure; just patient serious adverse event (stroke).The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event; there were no reports of alphavac mma gen 3 device malfunction during the procedure.No sample was returned for evaluation.It was concluded that the alphavac device was unrelated to the patient's stroke (distal embolization of thrombus); i.E.This was just an anticipated procedural complication.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: directions for use is provided with this device and contains the following statements: 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: · death · distal embolization of thrombus · vascular thrombosis a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: ALPHAVAC
• Common Device Name: ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14454360
• Report Number: 1319211-2022-00022
• Device Sequence Number: 17727554
• Product Code: QEZ
• UDI-Device Identifier: H787253020
• UDI-Public: H787253020
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 01/27/2023
• Device Model Number: 25-302
• Device Catalogue Number: 725302
• Device Lot Number: 420017
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 76 KG