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 Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was not returned for analysis.However, an image depicting the express ld device stuck in a 6fr introducer sheath was received.From the image it can be observed that the balloon was not inflated.The stent was also noted to be damaged and had moved proximally on the balloon.The proximal end of the stent was bunched as it entered the light green 6fr introducer sheath.

Event Description

Reportable based on investigation completed on 19jun2020.It was reported that advancing difficulties were encountered.The target lesion was located in the iliac artery.A 7.0x60x75cm express ld iliac / biliary stent was selected for use.However, the physician could not advance the stent through the sheath due to severe scarring at the entry site.Both the device and the sheath was removed and another 7fr sheath was used.The procedure was completed with a different device.No patient complications reported.However, investigation revealed stent damage and stent moved on balloon.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10200079
• MDR Text Key: 196585505
• Report Number: 2134265-2020-08558
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392231
• UDI-Public: 08714729392231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• 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: 06/26/2020

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: 12/11/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024917858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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