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

Model Number	H74939293054030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment occurred.A 5 x 40 x 130 innova self-expanding was selected for use.During the preparation, the stent appeared to be partially deployed after flushing the back end.It was uncertain whether the stent was already partially deployed prior to flushing or if the flushing process caused the issue.The procedure was completed with another of the same 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23486669
• Report Number: 2124215-2025-79293
• Device Sequence Number: 10487930
• Product Code: NIP
• UDI-Device Identifier: 08714729873907
• UDI-Public: (01)08714729873907(17)300410(10)36281245
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 11/06/2025

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: H74939293054030
• Device Catalogue Number: H74939293054030
• Device Lot Number: 0036281245
• 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: 10/08/2025
• Initial Report FDA Received Date: 11/06/2025
• Date Device Manufactured: 04/11/2025
• 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