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

Model Number	H74939293076030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent premature deployment and overstimulation occurred, requiring medical intervention.The stenosed target lesion was located in the fistula.A 7 x 60 x 130 innova vascular was selected for used in a procedure via arm approach.However, during the stent deployment, the stent prematurely deployed and was incorrectly positioned, floating freely within the blood vessel.The physician attempted to resolve the issue by using a second stent to trap the first one, but this was unsuccessful.Consequently, the patient's electrocardiogram (ekg) changed, and the patient experienced overstimulation.The patient was then sent to emergency for further treatment.
Additional Manufacturer Narrative
B5 describe event or problem: additional information.
Event or Problem Description
It was reported that stent premature deployment and overstimulation occurred, requiring medical intervention.The stenosed target lesion was located in the fistula.A 7 x 60 x 130 innova vascular was selected for used in a procedure via arm approach.However, during the stent deployment, the stent prematurely deployed and was incorrectly positioned, floating freely within the blood vessel.The physician attempted to resolve the issue by using a second stent to trap the first one, but this was unsuccessful.Consequently, the patient's electrocardiogram (ekg) changed, and the patient experienced overstimulation.The patient was then sent to the emergency room for further treatment.It was further reported that the stent was being placed in the superficial femoral artery (sfa).Additionally, the physician did not attempt to deploy the stent before it deployed prematurely in the sfa.The stent remains in the patient.
Event or Problem Description
It was reported that stent premature deployment and overstimulation occurred, requiring medical intervention.The stenosed target lesion was located in the fistula.A 7 x 60 x 130 innova vascular was selected for used in a procedure via arm approach.However, during the stent deployment, the stent prematurely deployed and was incorrectly positioned, floating freely within the blood vessel.The physician attempted to resolve the issue by using a second stent to trap the first one, but this was unsuccessful.Consequently, the patient's electrocardiogram (ekg) changed, and the patient experienced overstimulation.The patient was then sent to the emergency room for further treatment.It was further reported that the stent was being placed in the superficial femoral artery (sfa).Additionally, the physician did not attempt to deploy the stent before it deployed prematurely in the sfa.The stent remains in the patient.
Additional Manufacturer Narrative
This report is being submitted to correct the h6 - patient codes (2) in section h, device manufacturers only.

• 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 ; 6128757234
• MDR Report Key: 20893403
• Report Number: 2124215-2024-77673
• Device Sequence Number: 21025965
• Product Code: NIP
• UDI-Device Identifier: 08714729874096
• UDI-Public: 08714729874096
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 02/17/2025

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: H74939293076030
• Device Catalogue Number: H74939293076030
• Device Lot Number: 0034016069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/22/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/18/2025
• Date Device Manufactured: 05/13/2024
• 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