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

Model Number	H74939293072030
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Defective Device (2588); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent fracture occurred, requiring intervention.Vascular access was obtained via antegrade approach.The 80% stenosed target lesion was located in the mild to moderately tortuous and severely calcified superficial femoral artery.After pre-dilation with 6x100 balloon, a 7 x 200 x 130 innova self-expanding stent was advanced for treatment.However, resistance was encountered through the sheath and vessel.After the stent was deployed, there were difficulties in removing the stent delivery system.It became stuck and was unable to be removed from the.14 thruway wire.The white handle was opened and the catheter was manually pulled back to remove it from the body.Upon inspection, a stent fragment was still attached to the catheter, while the other portion remained inside the body.Subsequently, the stent appeared elongated.Another 7x150x100 stent was placed in the fractured stent struts to ensure apposition and post dilation was performed.The final angiography showed both stents are well apposed with no further issues.There was no patient complications noted as a result of this event.
Additional Manufacturer Narrative
B3 date of event: the event date was not provided at the time of reporting.The first date of the month may (aware date) was selected.
Additional Manufacturer Narrative
B3 date of event: the event date was not provided at the time of reporting.The first date of the month may (aware date) was selected.Device evaluated by mfr: the innova device was returned for analysis with only the nose cone, part of rack, and outer sheath received.A visual and tactile examination identified that the device was received with the stent partially deployed on the delivery system.The stent was also noted to be damaged.Multiple outer sheath kinks were observed along the length of the device, and the outer sheath was accordioned.A visual examination identified that part of the handle was not returned with the device and a break in the rack was noted.A visual examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that the stent fracture occurred, requiring intervention.Vascular access was obtained via antegrade approach.The >80% stenosed target lesion was located in the mild to moderately tortuous and severely calcified superficial femoral artery.After pre-dilation with 6x100 balloon, a 7 x 200 x 130 innova self-expanding stent was advanced for treatment.However, resistance was encountered through the sheath and vessel.After the stent was deployed, there were difficulties in removing the stent delivery system.It became stuck and was unable to be removed from the.14 thruway wire.The white handle was opened and the catheter was manually pulled back to remove it from the body.Upon inspection, a stent fragment was still attached to the catheter, while the other portion remained inside the body.Subsequently, the stent appeared elongated.Another 7x150x100 stent was placed in the the fractured stent struts to ensure apposition and post dilation was performed.The final angiography showed both stents are well apposed with no further issues.There was no patient complications noted 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: 22132054
• Report Number: 2124215-2025-34783
• Device Sequence Number: 20704673
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)260126(10)30938218
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/10/2025

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 Expiration Date: 01/26/2026
• Device Model Number: H74939293072030
• Device Catalogue Number: H74939293072030
• Device Lot Number: 0030938218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown