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

Model Number H74938046830750

Device Problems Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device was not received for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls as per the product specification.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that stent moved on balloon.The target lesion was located in the left superficial femoral artery (sfa).A 8.0x30x75cm express® ld iliac / biliary stent was advanced to treat the lesion.However, the device got caught between the stent strut a previously deployed innova stents.When the device was removed, the stent had started to came off of the balloon.The physician then deployed the stent in the mid sfa in between two overlapping innova stents to keep it from floating away.The procedure was then completed.No patient complications were reported and the patient's status was fine.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6911794
• MDR Text Key: 88060918
• Report Number: 2134265-2017-09608
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: 08714729579670
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/11/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2020
• Device Model Number: H74938046830750
• Device Catalogue Number: 38046-83075
• Device Lot Number: 0020885774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR