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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right common iliac artery.A 9.0x30x135 cm express ld iliac / biliary stent was advanced for treatment but the physician decided not to deploy the stent.However, as the physician taking the stent out of the body, it slid off the balloon catheter.A 6x20 charger balloon catheter was placed to deploy the stent and the procedure completed.No patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the right common iliac artery.A 9.0x30x135 cm express ld iliac / biliary stent was advanced for treatment but the physician decided not to deploy the stent.However, as the physician taking the stent out of the body, it slid off the balloon catheter.A 6x20 charger balloon catheter was placed to deploy the stent and the procedure completed.No patient complications were reported.It was further reported that images were performed while positioning the 9.0x30x135 cm express ld.The physician was intending to use the stent to extend the 7 x 57 express ld to right common iliac/ distal aorta.However, the physician decided the initial stent (7 x 57 express ld) placed in the right common iliac artery was sufficient, so decided not to deploy the additional stent.When the 9.0x30x135 cm express ld was pulled back through the 7 x 57 stent, it was caught by stent struts and slid off the deployment balloon catheter into the right common iliac artery.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with the stent detached from the balloon.The stent was not returned for analysis.A visual examination found that the balloon 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 stent crimp marks were clearly visible on the balloon material.The device was returned with the stent completely detached from the balloon catheter.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 issues with the shaft that could potentially have contributed to the complaint incident.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 9.0x30x135 cm express ld iliac / biliary stent was advanced for treatment but the physician decided not to deploy the stent.However, as the physician taking the stent out of the body, it slid off the balloon catheter.A 6x20 charger balloon catheter was placed to deploy the stent and the procedure completed.No patient complications were reported.It was further reported that images were performed while positioning the 9.0x30x135 cm express ld.The physician was intending to use the stent to extend the 7 x 57 express ld to right common iliac/ distal aorta.However, the physician decided the initial stent (7 x 57 express ld) placed in the right common iliac artery was sufficient, so decided not to deploy the additional stent.When the 9.0x30x135 cm express ld was pulled back through the 7 x 57 stent, it was caught by stent struts and slid off the deployment balloon catheter into the right common iliac artery.

• 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: 8827038
• Report Number: 2134265-2019-08701
• Device Sequence Number: 11380373
• Product Code: NIO
• UDI-Device Identifier: 08714729392491
• UDI-Public: 08714729392491
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0022444017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 08/28/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR