MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Innova? Vascular; Stent, Superficial femoral artery

Model Number	H74939293056030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent fractured occurred.A 5 x 60 x 130 innova stent self expanding was selected for use.During the procedure, the stent was deployed, however, the device fractured during deployment and was retracted and removed from the patient.A replacement innova stent was then used, but the same issue occurred.A third innova stent was subsequently opened and deployed successfully, allowing the procedure to be completed.No patient complications were reported, and the patient was stable as a result of this event.
Additional Manufacturer Narrative
B3: used the first date of the month of the aware date as no event date was provided.

• 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 ; +1(763)494-1632
• MDR Report Key: 25796562
• Report Number: 2124215-2026-37350
• Device Sequence Number: 12261867
• Product Code: NIP
• UDI-Device Identifier: 08714729873914
• UDI-Public: (01)08714729873914(17)300730(10)37100600
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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: H74939293056030
• Device Catalogue Number: H74939293056030
• Device Lot Number: 0037100600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 07/31/2025
• 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