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

Model Number	H74939293062030
Medical Device Problem Codes	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	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed, and the stent stretched.Vascular access was obtained via contralateral approach.The chronic total occlusion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 6 x 200 x 130 innova vascular stent was advanced for peripheral artery disease treatment.During the procedure, this stent was difficult to deploy; only 6cm deployed when it would no longer deploy all the way, even when the pull grip was utilized.Subsequently, the handle was taken apart in order to complete stent deployment.However, as a result of this event, the stent stretched approximately 100 mm.The procedure was completed, and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the innova device was returned for analysis.During the visual inspection, it was noted that the handle was received in an open position.There was evidence of inner prolapse, and a break was observed in the pull grip handle.Additionally, the device was returned with the stent already deployed from the delivery system.No issues were identified with the tip of the device during the visual examination.However, multiple kinks were found in the outer sheath upon both visual and tactile inspection.
Event or Problem Description
It was reported that the stent partially deployed, and the stent stretched.Vascular access was obtained via contralateral approach.The chronic total occlusion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 6 x 200 x 130 innova vascular stent was advanced for peripheral artery disease treatment.During the procedure, this stent was difficult to deploy; only 6 cm deployed when it would no longer deploy all the way, even when the pull grip was utilized.Subsequently, the handle was taken apart in order to complete stent deployment.However, as a result of this event, the stent stretched approximately 100 mm.The procedure was completed, and there were no patient complications as a result of this event.It was further reported that the stenosed target lesion is 100% and the stent looked normal when opened and no kinks detected.There was some force to get the stent to track to the desired location causing to failure on deployment.Also, the stent did not fracture however, it did elongate.

• 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: 22310251
• Report Number: 2124215-2025-40118
• Device Sequence Number: 7997889
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)260126(10)30938219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/24/2025

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 Expiration Date: 01/26/2026
• Device Model Number: H74939293062030
• Device Catalogue Number: H74939293062030
• Device Lot Number: 0030938219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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
• Patient Sex: Unknown