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

Model Number	26924
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Fracture (1260); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to deploy and was deformed, fractured and failed to expand.An 8x60x130 innova vascular self expanding stent was selected for use in a procedure in the external iliac artery.During the procedure, the user noted the thumbwheel was operating differently than expected and upon deployment, it was apparent the stent was not properly expanding.Additionally, per imaging, the stent appeared to be broken in two pieces.A second innova stent was placed to line the original stent.Upon post dilation it was confirmed that the initial innova stent was elongated based on a 60mm balloon being used for post dilation, and the stent being at least 10mm shorter than that balloon.It was reported that the patient was unharmed.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11675080
• Report Number: 2134265-2021-04797
• Device Sequence Number: 14234163
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 08/27/2025
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0025907917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention