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

Model Number 20226

Device Problem Difficult to Advance (2920)

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

Event Date 07/23/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.A 8.0x40x135cm and a 7.0x60x135cm express-b-i ld stents were advanced for treatment.However, during the procedure, both stents failed to advance through sheath.The procedure was aborted and there were no patient complications reported.

Event Description

It was reported that the procedure was cancelled.A 8.0x40x135cm and a 7.0x60x135cm express-b-i ld stents were advanced for treatment.However, during the procedure, both stents failed to advance through sheath.The procedure was aborted and there were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: express-b-i ld was received for analysis.The device was received advanced through the customers 6fr sheath.The recommended introducer sheath size for this express ld device as per express specification is a 6fr.A visual inspection found the sheath to be damaged beginning at the hub and extending distally for approximately 15mm.A visual and microscopic examination also found the lining of the sheath to be wrapped around the tip of the express device and had been pulled distally out of the sheath together with the balloon catheter.The lining of the sheath was also found to be wrapped around the distal section of the device that had exited the sheath.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A microscopic examination found the stent crimped in the correct location on the balloon.The first three rows of the distal stent struts were found to be lifted/damaged.This type of damage is consistent with excessive force being applied to the device.No issues were noted with the of the device's tip.The lining of the customer's sheath was noted to be tightly wrapped around the tip of the device.A visual and tactile examination identified no issues with the shaft of the device.No other issues were noted with the device that could potentially have contributed to the complaint incident.

• 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: 12303633
• MDR Text Key: 265901916
• Report Number: 2134265-2021-09852
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0026969523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/16/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1