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

Model Number	26929
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the stent prematurely deployed.The target lesion was 99% stenosed, severely calcified with plaque and located in the mid to distal superficial femoral artery (sfa).Vascular access was obtained via an ipsilateral pedal approach from the posterior tibial artery.Pre-dilation was performed with a 5x150 sterling balloon catheter.During advancement of the innova stent delivery system through the lesion, the stent prematurely deployed by approximately 5 to 10mm.The stent and sheath were removed together from the patient.The procedure was completed with the implant of a new device.No patient complications occurred.

• 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: 12569630
• Report Number: 2134265-2021-12001
• Device Sequence Number: 872131
• Product Code: NIP
• UDI-Device Identifier: 08714729873945
• UDI-Public: 08714729873945
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: 03/08/2025
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0025325074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1
• Patient Age: 63 YR