MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported stent dislodgement occurred.A 10.0x40x135 cm express ld iliac / biliary stent was used to advanced through the non-bsc 7fr sheath, resistance were encountered and it did not cross the lesion.The device was removed and noticed that the stent became dismounted from the catheter outside the patient's body.The procedure was completed using another of the same device that fit through the sheath.No patient complications were reported.
Event or Problem Description
It was reported stent dislodgement occurred.A 10.0x40x135 cm express ld iliac/biliary stent was used to advanced through the non-bsc 7fr sheath, resistance were encountered and it did not cross the lesion.The device was remoevd and noticed that the stent became dismounted from the catheter outside the patient's body.The procedure was completed using another of the same device that fit through the sheath.No patient complications were reported.The device was returned with the stent mounted onto the balloon.The customer's 7fr introducer sheath was not returned for analysis.The recommended sheath size for this express device is a 7fr introducer sheath.Investigator was unable to advance the device through a boston scientific 7f introducer sheath due to damage to the distal stent struts.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 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.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.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7965789
• Report Number: 2134265-2018-61939
• Device Sequence Number: 221690
• Product Code: NIO
• UDI-Device Identifier: 08714729392385
• UDI-Public: 08714729392385
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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): 11/07/2018

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: 08/02/2019
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0019542976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1