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

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that the stent was partially deployed.A 6mm x 40mm x 130cm innova stent was selected for use in a procedure, within the mid portion of the superficial femoral artery (sfa).During the procedure, as the stent was being loaded onto the guidewire, the health care provider (hcp) noticed the stent was partially deployed about 5mm.The thumb wheel was not used or activated.The stent reportedly felt stuck on the guidewire and the hcp had a difficult time unloading the stent off the wire.The device was safely removed from the guidewire and was discarded.The procedure was completed with another of the same device.The stent did not enter the patient and no adverse effects were reported.

• 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: 11475114
• Report Number: 2134265-2021-03229
• Device Sequence Number: 3877262
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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: 06/07/2025
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0025570238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GLIDE WIRE (STIFF)