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

Model Number	H74938047740130
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that inadequate apposition occurred.The target lesion was located in the iliac artery.A 7.0x40x135 cm express® ld iliac / biliary stent was implanted to treat the lesion.However, the stent was not well apposed.The physician removed the device according to the standard method without issue.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 received with the stent fully crimped on the balloon.There was no evidence of any positive pressure having been applied to the balloon.A small trace of solidified blood was present between a balloon fold.An examination of the entire length of the crimped stent found no damage to any of the stent struts.A kink was noted in the shaft at 13.6cm proximal to the tip.This type of damage is consistent with excessive force having been applied to the shaft.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure with no resistance noted.The stent deployed fully from the balloon.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was reported that inadequate apposition occurred.The target lesion was located in the iliac artery.A 7.0x40x135 cm express® ld iliac / biliary stent was implanted to treat the lesion.However, the stent was not well apposed.The physician removed the device according to the standard method without issue.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: 6360290
• Report Number: 2134265-2017-01566
• Device Sequence Number: 799109
• Product Code: NIO
• UDI-Device Identifier: 08714729392446
• UDI-Public: (01)08714729392446(17)20180315(10)17795020
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: 03/15/2018
• Device Model Number: H74938047740130
• Device Catalogue Number: 38047-74013
• Device Lot Number: 17795020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1