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

Model Number	H74939293088030
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); 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	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and stretched.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery (sfa).An 8 x 80 x 130 innova stent self-expanding was selected for use.During the procedure, when deployment was attempted, only approximately 1.5cm of the stent deployed.The thumb wheel was used to where they could see the initial opening of the distal end of the stent; however, the wheel no longer moved at that point.The physician attempted to pull the plunger at the proximal end of the stent delivery system (sds), but it would not move; it was noted that the partially deployed stent was opposed to the vessel wall.The physician then pulled back the entire sds in an attempt to retrieve the stent.The stent deployed and became stretched in the sfa, covering the lesion but also stenting more proximally in the artery.The 80mm stent was estimated to be approximately 120mm long implanted.The procedure was completed with this 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 multiple outer sheath kinks.The device was received with the stent already deployed from the delivery system.The deployed stent was not returned with the device.A visual examination identified no issues with the tip of the device.A visual examination identified no issues or damage to the outside of the handle of the device.The investigator opened the handle of the device.There was evidence of inner prolapse.This concludes the product analysis.
Event or Problem Description
It was reported that the stent partially deployed and stretched.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery (sfa).An 8 x 80 x 130 innova stent self-expanding was selected for use.During the procedure, when deployment was attempted, only approximately 1.5cm of the stent deployed.The thumb wheel was used to where they could see the initial opening of the distal end of the stent; however, the wheel no longer moved at that point.The physician attempted to pull the plunger at the proximal end of the stent delivery system (sds), but it would not move; it was noted that the partially deployed stent was opposed to the vessel wall.The physician then pulled back the entire sds in an attempt to retrieve the stent.The stent deployed and became stretched in the sfa, covering the lesion but also stenting more proximally in the artery.The 80mm stent was estimated to be approximately 120mm long implanted.The procedure was completed with this 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: 23125993
• Report Number: 2124215-2025-66040
• Device Sequence Number: 7394149
• Product Code: NIP
• UDI-Device Identifier: 08714729874195
• UDI-Public: (01)08714729874195(17)300709(10)36941276
• 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): 12/02/2025

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: H74939293088030
• Device Catalogue Number: H74939293088030
• Device Lot Number: 0036941276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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 Age: 70 YR
• Patient Sex: Male