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

Model Number 26924

Device Problems Mechanical Problem (1384); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed.A 6 x 80 x 130 innova self expanding stent was selected for use for a lower extremity angio procedure.During procedure inside the patient, the innova stent was unable to cross the lesion.The physician decided to remove the stent.As the stent was removed from the 6f sheath, the outer sheath of the stent delivery system was accidentally retracted and the stent was exposed.A new innova stent 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7855164
• MDR Text Key: 119540916
• Report Number: 2134265-2018-60852
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874010
• UDI-Public: 08714729874010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0019550509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2016
• 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