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

Model Number	H74938046740750
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.This investigation is assigned the most probable root cause classification of user / use error since the complaint investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.(b)(4).
Event or Problem Description
It was reported that stent premature deployment occurred.The target lesion was located in the left iliac vein.A 7.0x40x75cm express® ld iliac / biliary was advanced to treat the lesion.However, the stent was accidentally deployed in the sheath.The whole system was removed and physician decided to an open repair instead.No patient complications were reported and the patient's status was fine.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6587072
• Report Number: 2134265-2017-04987
• Device Sequence Number: 11007823
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: (01)08714729392217(17)20191122(10)19996854
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2017

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: 11/22/2019
• Device Model Number: H74938046740750
• Device Catalogue Number: 38046-74075
• Device Lot Number: 19996854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR