MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number H74938047960130

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the iliac artery.During preparation of a 9.0x60x135cm express® ld stent, the distal end of the stent was irregular and a kink was noted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned with the stent fully mounted on the device.Rows one and two of the distal stent were noted to be displaced.The balloon showed no signs of inflation.No issues were noted with the tip or markerbands.The shaft of the device was severely stretched beginning at the hub of the device and extending approximately 230mm along the shaft.This type of damage is consistent with excessive tensile force being applied to the device.No other issues were noted during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the iliac artery.During preparation of a 9.0x60x135cm express ld stent, the distal end of the stent was irregular and a kink was noted.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7514330
• MDR Text Key: 108258154
• Report Number: 2134265-2018-04068
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392514
• UDI-Public: 08714729392514
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P090003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: H74938047960130
• Device Catalogue Number: 38047-96013
• Device Lot Number: 21161466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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