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

Model Number 26924

Device Problems Defective Device (2588); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  Injury  

Event Description

It was reported that the stent was difficult to position and additional intervention was required.A 7mm x 80mm x 130cm innova vascular self-expanding stent was selected for use in a stenting procedure in the superficial femoral artery.During the procedure while deploying the stent, the delivery system splintered.The stent deployed fully, but it fell a few millimeters short of the intended target lesion.A balloon was used on the portion of the lesion not covered by the stent.A satisfactory result was accomplished.No patient complications were 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: 11564174
• MDR Text Key: 242080375
• Report Number: 2134265-2021-03787
• Device Sequence Number: 1
• Product Code: NIP
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention