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

Model Number H74938046940750

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the common iliac artery.After a 6fr introducer sheath was inserted, a 9.0x40x75cm express® ld iliac / biliary stent was advanced to treat the lesion.However, difficulties were encountered during introduction of the device which resulted to the distal tip of the stent becoming frayed.The physician determined that the sheath was too small and so it was upsized from 6fr to 7fr.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr: a visual and microscopic examination was performed on the returned device.The device was returned with the stent fully mounted onto the delivery device.The customer¿s 6fr introducer sheath was not returned for analysis.The recommended sheath size for this express-b-i ld pmtd 9.0x40x75cm device is a 7fr introducer sheath.Investigator was unable to advance the device through a boston scientific 7f introducer sheath due to the damaged stent.The balloon was noted to be tightly folded and had not been subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.The device was returned with the stent fully mounted onto the delivery system.The stent was in the correct position on the balloon material.It was noted that struts at the distal section of the stent were damaged and were raised from the crimped stent.This kind of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.No other issues were identified during the product analysis.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.It was reported that the physician used a 6f introducer sheath.The recommended sheath size as per dfu for this 9.0x40x75cm express® ld iliac / biliary stent is a 7fr introducer sheath.The complaint event and damage identified was mostly likely a result of the physician using the wrong size of introducer sheath during preparation.When the physician attempted to advance the device through the 6f introducer sheath it would have encountered great resistance resulting in damage to the distal end of the stent (b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the common iliac artery.After a 6fr introducer sheath was inserted, a 9.0x40x75cm express® ld iliac / biliary stent was advanced to treat the lesion.However, difficulties were encountered during introduction of the device which resulted to the distal tip of the stent becoming frayed.The physician determined that the sheath was too small and so it was upsized from 6fr to 7fr.The procedure was completed with a different device.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: 7046199
• MDR Text Key: 93181055
• Report Number: 2134265-2017-11542
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392330
• UDI-Public: 08714729392330
• 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,Followup
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: H74938046940750
• Device Catalogue Number: 38046-94075
• Device Lot Number: 0021183837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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