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	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the bsc aware date since event date not provided.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right common iliac artery.A 7.0x40x75cm express ld stent was selected for use.However, when the stent was advanced on the wire into the sheath, it would not enter and noticed that the stent was off the balloon.The procedure was completed with a different device.No patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event: updated from (b)(6) 2020 to (b)(6) 2020.E1 initial reporter name updated.E1 initial reporter phone number updated.Device evaluated by mfr.: express ld device - 7x40x75cm was received for analysis.A visual and microscopic examination identified that the stent had been moved to position that was approximately 18mm proximal of the distal markerband on the device.A microscopic examination found that rows 6,7 and 8 of the proximal stent struts were damaged.No other issues were identified with the stent that could potentially have contributed to the complaint incident.A visual examination identified that the balloon 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.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right common iliac artery.A 7.0x40x75cm express ld stent was selected for use.However, when the stent was advanced on the wire into the sheath, it would not enter and noticed that the stent was off the balloon.The procedure was completed with a different device.No patient complications nor injuries 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: 10356307
• Report Number: 2134265-2020-10333
• Device Sequence Number: 11628645
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: 08714729392217
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/21/2020

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: 11/19/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024800342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR