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

Model Number 20226

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: used (b)(6) 2020 as the information available is (b)(6) 2020 only.

Event Description

It was reported that removal difficulties and stent dislodgement occurred, requiring additional intervention.The target lesion was located at the right iliac vein.A 8.0x40x75cm express ld stent was advanced for treatment.A picture was taken but could not see the vessel well, so the stent was pulled back; however, resistance was felt.During fluoroscopy, it was noticed that the stent came off of the balloon.The sheath, balloon and stent were pulled back in one unit.The sheath and balloon were out of the body and it was noted that the stent was left in the femoral artery right at the access site.Additional lidocaine was given, and a small nick was made in the skin to pull the stent out using the hemostat.The procedure was continued and a new sheath was inserted in the left femoral artery.A new stent was advanced and deployed without complications.The patient was stable during the whole procedure and was sent to recovery after.The patient was discharged on the same day.

Event Description

It was reported that removal difficulties and stent dislodgement occurred, requiring additional intervention.The target lesion was located at the right iliac vein.A 8.0x40x75cm express ld stent was advanced for treatment.A picture was taken but could not see the vessel well, so the stent was pulled back; however, resistance was felt.During fluoroscopy, it was noticed that the stent came off of the balloon.The sheath, balloon and stent were pulled back in one unit.The sheath and balloon were out of the body and it was noted that the stent was left in the femoral artery right at the access site.Additional lidocaine was given, and a small nick was made in the skin to pull the stent out using the hemostat.The procedure was continued and a new sheath was inserted in the left femoral artery.A new stent was advanced and deployed without complications.The patient was stable during the whole procedure and was sent to recovery after.The patient was discharged on the same day.

Manufacturer Narrative

B3 - date of event: initial reporter confirmed event date was (b)(6) 2019.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10442933
• MDR Text Key: 204034948
• Report Number: 2134265-2020-11557
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392279
• UDI-Public: 08714729392279
• Combination Product (y/n): N
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0023765606
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR