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

Model Number	20226
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x30x75cm express ld was selected to treat a stenosed lesion in the iliac vein.During the procedure while inside the patient, the stent came off the balloon.The stent was recovered and another stent with a 135cm shaft was selected to complete the procedure.No patient complications were reported and the patient's status was fine post procedure.Device evaluated by manufacturer: a visual and microscopic examination was performed on the returned device, the following attributes were examined: the delivery system was returned for analysis with the stent fully mounted onto the delivery system.A visual and tactile examination on the catheter identified one kink on the catheter of the device approximately 1mm distal to the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that could have contributed to the complaint incident.A visual and microscopic examination was performed on the tip and markerbands of the device.No damage or any issues were noted with the tip or markerbands of the device that could have contributed to the complaint incident.A visual and microscopic examination was performed on the balloon material.The balloon material was tightly folded and had not been subjected to positive pressure.No issues were noted with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination was performed on the stent.The stent was fully crimped onto the delivery system.The stent was noted to have moved distally on the balloon material and was not in the correct position between the markerbands.The crimped stent was undamaged.No damage or any issues were noted with the stent that could have contributed to the stent movement.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: 7915197
• Report Number: 2134265-2018-61337
• Device Sequence Number: 11098686
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 09/27/2018

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: 05/20/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022145184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR