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

Model Number	20226
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2019
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 damage occurred.The target lesion was located in the iliac artery.A 8.0x60x135 cm express ld iliac / biliary stent was advanced for treatment.However, it was noted that a defect was found in the stent struts.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.The balloon was received tightly folded which indicates it had not been subjected to positive pressure.No issues were noted with balloon.A visual and microscopic examination found the stent to be mounted in the correct position on the device.The first strut was lifted on the distal end of the stent.No other issues were identified with the stent.A visual and tactile examination found the shaft of the device identified no issues.A visual and microscopic examination of the device identified no issues with the markerbands or tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the iliac artery.A 8.0x60x135 cm express ld iliac / biliary stent was advanced for treatement.However, it was noted that a defect was found in the stent struts.The procedure was completed with another of the same device.There were no patient complications 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: 9521564
• Report Number: 2134265-2019-16193
• Device Sequence Number: 458373
• Product Code: NIO
• UDI-Device Identifier: 08714729392484
• UDI-Public: 08714729392484
• 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): 03/02/2020

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: 04/04/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0023599535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1