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

Model Number 26926

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: older than 18 years.

Event Description

It was reported that the stent became stuck on the guidewire.An innova stent was selected for use for a lower limb stent procedure in the left superficial femoral artery (sfa).The target lesion was moderately tortuous, severely calcified and 100% stenosed.During procedure, the stent delivery system became stuck to a non-bsc guidewire and the delivery shaft became stretched.The stent was then removed with the guidewire together, and the procedure was completed with another innova stent.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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8214561
• MDR Text Key: 132046708
• Report Number: 2134265-2018-64608
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873686
• UDI-Public: 08714729873686
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

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: 12/31/2018
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0018733069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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