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

Model Number 26926

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Event 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10440666
• MDR Text Key: 204012481
• Report Number: 2134265-2020-11564
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1