MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Lot Number 23765606

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Doctor was advancing the stent to the right iliac.A picture was taken and could not see vessel well, stent was pulled back at which point there was resistance.Dr.Stepped on fluro and noticed that the stent had come off of the balloon.He then pulled the sheath, balloon, and stent back in one unit.Upon the sheath and balloon coming out of the body, it was noted that the stent was not out of the body.Dr.Noticed that the stent was in the left femoral artery right at the access site.Additional lidocaine was given, and a small nick was made in the skin and dr.Was able to pull the stent out using the hemostat.The case continued and a new sheath was inserted into the left femoral artery.A new stent was advanced and placed and deployed with no complication.Patient was stable during the whole procedure and was sent to recovery when done.Case continued with no further complications.Patient was discharged home on the same day.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10016957
• MDR Text Key: 189614228
• Report Number: 10016957
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 23765606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA