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

Model Number	H74939293066030
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.The target lesion was located in the lower extremity.A 6 x 60 x 130 innova self-expanding stent was selected for use.Prior to the procedure, the stent started to deploy while being loaded onto the wire, before entering the patient's body.The yellow safety mechanism was still in place.The stent did not enter the patient's body and was removed from the wire, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the innova device was returned to our post market quality assurance laboratory.A visual and tactile examination identified an outer sheath kink 1mm distal from the distal end of the nose cone.The device was received with the stent already deployed from the delivery system.No issues noted with the deployed stent.A visual examination identified no issues with the tip and handle of the device.The safety lock was still attached to the handle, and there was no evidence of inner prolapse.This concludes the product analysis.
Event or Problem Description
It was reported that inadvertent deployment occurred.The target lesion was located in the lower extremity.A 6 x 60 x 130 innova self-expanding stent was selected for use.Prior to the procedure, the stent started to deploy while being loaded onto the wire, before entering the patient's body.The yellow safety mechanism was still in place.The stent did not enter the patient's body and was removed from the wire, and 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: 23395153
• Report Number: 2124215-2025-76794
• Device Sequence Number: 15956248
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: (01)08714729874003(17)300220(10)35907221
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/18/2025

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: H74939293066030
• Device Catalogue Number: H74939293066030
• Device Lot Number: 0035907221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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