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

Model Number	26926
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was stuck on the guidewire.A 7mm x 150mm innova self expanding stent was selected for an endovascular therapy procedure in the superficial femoral artery.A non-bsc 0.035" guidewire was also used.The innova was inserted from the opposite side of the leg, and there was difficult advancing.The device ultimately failed to cross the lesion.The device became stuck on the guidewire and could not be removed.The innova and guidewire were therefore removed together.The guidewire's shaft was noted to be kinked upon removal.A similar device was used to complete the procedure.There were no patient complications 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: 10440666
• Report Number: 2134265-2020-11564
• Device Sequence Number: 2676407
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2020

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: 07/19/2020
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0020910180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1