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

Model Number	H74938047960130
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7514330
• Report Number: 2134265-2018-04068
• Device Sequence Number: 1254564
• Product Code: NIO
• UDI-Device Identifier: 08714729392514
• UDI-Public: 08714729392514
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1