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

Model Number	H74939293071230
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the moderately calcified right femoral artery access to right superficial femoral artery via antegrade approach.The vessel length was approximately 120mm.A 6.0 x 150 x 150 ranger balloon catheter was advanced for pre-dilation in the angioplasty procedure.Post angioplasty, it was noted that the lesion had some recoil.Thus, a 7 x 120 x 130 innova vascular was selected for use.Upon deployment, the stent did not look to be 120mm in length.The stent was deployed.The physician decided not to deploy a second stent to cover any portion of the lesion that was missed, since the same ranger was used to post dilate both ends and the area extending beyond the stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the innova was returned for analysis.A visual and tactile examination identified an outer sheath kink 1mm distal from the distal end of the nose cone.An inner sheath kink was noted approximately 35mm proximal from the distal tip.The device was received with the stent already deployed from the delivery system.The deployed stent was not returned with the device.A break was noted in the pull grip handle.A visual examination identified no issues with the tip of the device.A visual examination identified no issues or damage to the handle of the device.The investigator opened the handle of the device.There was no evidence of inner prolapse.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the moderately calcified right femoral artery access to right superficial femoral artery via antegrade approach.The vessel length was approximately 120mm.A 6.0 x 150 x 150 ranger balloon catheter was advanced for pre-dilation in the angioplasty procedure.Post angioplasty, it was noted that the lesion had some recoil.Thus, a 7 x 120 x 130 innova vascular was selected for use.Upon deployment, the stent did not look to be 120mm in length.The stent was deployed.The physician decided not to deploy a second stent to cover any portion of the lesion that was missed, since the same ranger was used to post dilate both ends and the area extending beyond the stent.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: 23487608
• Report Number: 2124215-2025-79296
• Device Sequence Number: 10499165
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: (01)08714729874126(17)280906(10)32382675
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939293071230
• Device Catalogue Number: H74939293071230
• Device Lot Number: 0032382675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown