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

Model Number	H74938047730130
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.Vascular access was obtained via the left groin.The in-stent restenosed target lesion was located in the left iliac artery.A 7.0x30x135cm express® ld iliac/biliary stent was advanced to treat the lesion.However, it was noted that the stent came off of the stent delivery balloon.The dislodged stent was crushed against the vessel wall and another was implanted.The procedure was then completed.No further 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: 6329029
• Report Number: 2134265-2017-00879
• Device Sequence Number: 474823
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: (01)08714729579694(17)20191111(10)0019955140
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2019
• Device Model Number: H74938047730130
• Device Catalogue Number: 38047-73013
• Device Lot Number: 0019955140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention