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	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the subclavian artery.A 9.0x30x135 cm express ld iliac / biliary stent was advanced; however, while advancing through a guide catheter, resistance was encountered and the stent detached with the balloon.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: 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 mounted on to the balloon.A visual and microscopic examination identified that the stent had been moved approximately 10mm distally on the balloon.Both distal and proximal stent struts were noted to be lifted.No other issues were identified with the stent that could potentially 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 of the shaft identified no damage or any issues along the length of the device.The dfu states that this device is indicated for the treatment of atherosclerotic lesions found in iliac arteries up to 100 mm in length, with a reference diameter of 6 mm to 10 mm.The complaint device was used to treat the subclavian.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the subclavian artery.A 9.0x30x135 cm express ld iliac / biliary stent was advanced; however, while advancing through a guide catheter, resistance was encountered and the stent detached with the balloon.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 8650299
• Report Number: 2134265-2019-06001
• Device Sequence Number: 16653888
• Product Code: NIO
• UDI-Device Identifier: 08714729392491
• UDI-Public: 08714729392491
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 05/01/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022066095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1