MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA? VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293061030
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.The target lesion was located in the superficial femoral artery (sfa).A 6 x 100 x 130 innova stent self expanding was selected for use.During the procedure, when innova was advanced over the wire with the yellow safety lock in place, it was noted that 5 millimeters (mm) of the stent was deployed, and that the partial deployment occurred outside the patient.It was also reported that the package was damaged.The procedure was completed with alternate device.There were no patient complications as a result of this event.

• Brand Name: INNOVA? VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24885645
• Report Number: 2124215-2026-20310
• Device Sequence Number: 10330488
• Product Code: NIP
• UDI-Device Identifier: 08714729874027
• UDI-Public: (01)08714729874027(17)301112(10)37954247
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: H74939293061030
• Device Catalogue Number: H74939293061030
• Device Lot Number: 0037954247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2025
• 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