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

Model Number	H74939293071030
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• 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(612)875-7234
• MDR Report Key: 50060365
• Report Number: 2124215-2026-40423
• Device Sequence Number: 9349307
• Product Code: NIP
• UDI-Device Identifier: 08714729874119
• UDI-Public: (01)08714729874119(17)310426(10)39188654
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 09/30/2026

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: H74939293071030
• Device Catalogue Number: H74939293071030
• Device Lot Number: 0039188654
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/27/2026
• 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