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

Model Number	H74938047720130
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that the stent moved on balloon.The very tight stenosis was located in the ostial superior mesenteric artery.A 7.0x20x135 cm express® ld iliac / biliary stent was advanced to treat the lesion.However, as the stent was advanced, it was noted that the stent slide off.The procedure was completed with a new stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the delivery system was returned for analysis.The stent was returned fully attached to the complaint device.A visual and microscopic examination was performed on the returned delivery system.The balloon was tightly folded and did not appear to have been subjected to positive pressure.The stent was noted to have moved approximately 10mm forward on the balloon material.The stent was still noted to be fully crimped and no damage or any issues were noted with the stent that could have contributed to the complaint incident.No damage or any issues were noted to the balloon, tip, markerbands or shaft of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that the stent moved on balloon.The very tight stenosis was located in the ostial superior mesenteric artery.A 7.0x20x135 cm express® ld iliac / biliary stent was advanced to treat the lesion.However, as the stent was advanced, it was noted that the stent slide off.The procedure was completed with a new stent.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: 7487014
• Report Number: 2134265-2018-03953
• Device Sequence Number: 16573250
• Product Code: NIO
• UDI-Device Identifier: 08714729392439
• UDI-Public: 08714729392439
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 04/13/2018

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: 10/17/2020
• Device Model Number: H74938047720130
• Device Catalogue Number: 38047-72013
• Device Lot Number: 0021271182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR