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 Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 10.0x40x75cm express ld iliac/biliary stent was advanced for treatment and withdrawn undeployed.The express stent was then advanced again and it was noted that the distal edge of one stent struts was bent.The device was no longer used and replaced with another of the same device to complete the procedure.There were no patient complications nor injuries were reported.
Additional Manufacturer Narrative
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.The stent was mounted in the correct place on the balloon.Due to the condition of the stent, the investigator was unable to advance the device through an introducer sheath.The investigator attached the express ld device to a boston scientific encore inflation unit and positive pressure was applied.The balloon was successfully inflated to its rate of burst with no drop of pressure noted.No issues were noted with balloon that could potentially have contributed to the complaint incident.A visual and microscopic examination found one of the proximal stent struts on the first row was bent proximally.This type of damage is consistent with excessive force being applied to the device when advancing it through the introducer sheath.The investigator successfully deployed the stent without issue.No other issues were identified with the deployed stent.A visual and tactile examination identified no damage or any issues along the shaft of the device.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It was reported that stent damage occurred.A 10.0x40x75cm express ld iliac/biliary stent was advanced for treatment and withdrawn undeployed.The express stent was then advanced again and it was noted that the distal edge of one stent struts was bent.The device was no longer used and replaced with another of the same device to complete the procedure.There were no patient complications nor injuries were reported.

• 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: 8994578
• Report Number: 2134265-2019-10999
• Device Sequence Number: 3169274
• Product Code: NIO
• UDI-Device Identifier: 08714729392095
• UDI-Public: 08714729392095
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/26/2019

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: 06/24/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024007209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1