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

Model Number 20226

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: above 18 years and older.

Event Description

It was reported that stent damage occurred.A 10.0x40x135 cm express ld iliac biliary stent was selected for use for a stenting procedure in the arm.However, during preparation, it was noted that the end of the stent was deformed.The procedure was completed with different device.No patient complications reported and the patient's status was stable.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8413453
• MDR Text Key: 138564314
• Report Number: 2134265-2019-02365
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392385
• UDI-Public: 08714729392385
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0019009211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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