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	05/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the highly calcified superior mesenteric artery with severe angulation at takeoff of vessel from aorta.After engaging the lesion with a non-bsc sheath and 0.035 amplatz guidewire, a 6.0x30x135cm express ld stent was delivered into the lesion.The sheath position had to be adjusted and the stent was pulled back into the sheath.Due to the severe angle of the steerable sheath at the tip, the stent was pulled off of the balloon catheter as it was retracted back into the sheath through the curved tip of the sheath.This was noticed immediately and the entire sheath system, along with the wire and stent delivery system, was removed.The stent was retrieved from the sheath and nothing remain in the patient's body.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the highly calcified superior mesenteric artery with severe angulation at takeoff of vessel from aorta.After engaging the lesion with a non-bsc sheath and 0.035 amplatz guidewire, a 6.0x30x135cm express ld stent was delivered into the lesion.The sheath position had to be adjusted and the stent was pulled back into the sheath.Due to the severe angle of the steerable sheath at the tip, the stent was pulled off of the balloon catheter as it was retracted back into the sheath through the curved tip of the sheath.This was noticed immediately and the entire sheath system, along with the wire and stent delivery system, was removed.The stent was retrieved from the sheath and nothing remain in the patient's body.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluation by mfr.: express ld device - 6x30x135cm was returned for anaslysis.The device was returned with the stent completely detached from the device.A visual and microscopic examination identified that the stent had been completely detached from the device.A microscopic examination found the stent struts to be damaged along the entire length of the stent.The stent damage most probably occurred when attempting to withdraw the device back into the sheath.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.The stent crimp marks were clearly visible on the balloon material.A visual and microscopic examination identified no issues with the balloon material 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 identified no damage or any issues along the length of the device.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: 10123245
• Report Number: 2134265-2020-07583
• Device Sequence Number: 11357651
• Product Code: NIO
• UDI-Device Identifier: 08714729579687
• UDI-Public: 08714729579687
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/09/2020

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: 06/25/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0020814194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1