MAUDE Adverse Event Report: VESALIO, INC. PVASC 6.0 X 44 MM - FLOW RESTORATION, 3 DROP ZONES - 200 CM WIRE SYSTEM; PERIPHERAL MECHANICAL THROMBECTOMY

Model Number	VP-6044-F3RR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A pvasc 6.0x44 expandable tip detached during a procedure while attempting to withdraw the device through a stented region of the blood vessel.It was observed that the expandable tip got stuck on the strut of the stent.The physician unsuccessfully attempted to withdraw the detached tip.He decided to compress the expandable tip against the wall of the artery using a new stent.Following the device detachment and placement of new stent, the patient remained clinically stable and was discharged without any negative after-effects.

• Brand Name: PVASC 6.0 X 44 MM - FLOW RESTORATION, 3 DROP ZONES - 200 CM WIRE SYSTEM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY
• Manufacturer (Section D): VESALIO, INC.; 2305 historic decatur rd.; suite 100; san diego CA 92106 6071
• Manufacturer Contact: sharon shachar ; 2305 historic decatur rd.; suite 100; san diego, CA 92106-6071 ; 2486976616
• MDR Report Key: 22649127
• Report Number: 3014498720-2025-00002
• Device Sequence Number: 8763017
• Product Code: QEW
• UDI-Device Identifier: 00851279008514
• UDI-Public: 851279008514
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VP-6044-F3RR
• Device Catalogue Number: VP-6044-F3RR
• Device Lot Number: 032125B
• 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: Not provided
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Unknown