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

Model Number 26924

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  malfunction  

Event Description

It was reported stent placement difficulties occurred.A stenting procedure was being performed in the superficial femoral artery (sfa) ostium using a retrograde popliteal approach.As the innova 6 x 20 x 130 stent was positioned and deployment initiated, the stent moved forward and partially covered the profunda artery.It was noted the physician thought the device was being held steady in position and was surprised that the stent moved forward.The stent was post dilated and the procedure was completed with no adverse effect to the patient outcome.It was noted there was no need to do anything further, the physician just didn't like the final position of the stent.Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).A visual examination identified a kink at the nosecone.The stent was not returned.Per the customers statement the stent was deployed in the patient.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7976124
• MDR Text Key: 124548913
• Report Number: 2134265-2018-61997
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873983
• UDI-Public: 08714729873983
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0020754073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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