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

Model Number	H74938047760130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
It was reported that stent fracture and vessel perforation occurred, a patient went into surgery.The target lesion was located in the right external iliac artery.A 7.0 x 60 x 135 cm express® ld iliac / biliary stent was deployed at 12 atmospheres to the target lesion.However, when the delivery balloon was attempted to be removed, the deployed stent fractured in half.The stent perforated the artery and patient was then sent for surgery to remove the fractured stent.The physician was able to remove a part of the stent but had to operate again the next day to remove the stent completely.Blood flow was restored to the leg.No further patient complications were reported and the patient's status was stable post-surgery.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7423111
• Report Number: 2134265-2018-02961
• Device Sequence Number: 1093752
• Product Code: NIO
• UDI-Device Identifier: 08714729392453
• UDI-Public: 08714729392453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: 11/13/2020
• Device Model Number: H74938047760130
• Device Catalogue Number: 38047-76013
• Device Lot Number: 21383552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: TERUMO/10CM PINACLE DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR