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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred resulting to an additional intervention.Vascular access was obtained via the right femoral artery with a 6x45 non-boston scientific (bsc) sheath.The 75-90% stenosed target lesion was located in the tortuous and severely calcified external iliac artery.A 6.0x40x75cm express ld iliac / biliary stent was advanced for treatment.However, when the device was inserted over a.014 wire, the shaft length was determined to be not long enough to deploy the stent.The device was attempted to be removed; however, upon trying to pull it back into the sheath, the uninflated stent pulled off of the uninflated balloon, and was sitting on the 0.14 not expanded wire.The 6x45 sheath was replaced with a 7x45 non-bsc sheath.Subsequently, a 10x40 epic stent was used to trapped and crushed the express ld stent.The procedure was completed successfully with no patient complications were reported.
Event or Problem Description
It was reported that stent dislodgement occurred resulting to an additional intervention.Vascular access was obtained via the right femoral artery with a 6x45 non-boston scientific (bsc) sheath.The 75-90% stenosed target lesion was located in the tortuous and severely calcified external iliac artery.A 6.0x40x75cm express ld iliac / biliary stent was advanced for treatment.However, when the device was inserted over a.014 wire, the shaft length was determined to be not long enough to deploy the stent.The device was attempted to be removed; however, upon trying to pull it back into the sheath, the uninflated stent pulled off of the uninflated balloon, and was sitting on the 0.14 not expanded wire.The 6x45 sheath was replaced with a 7x45 non-bsc sheath.Subsequently, a 10x40 epic stent was used to trapped and crushed the express ld stent.The procedure was completed successfully with no patient complications were reported.
Additional Manufacturer Narrative
An express ld device was received for analysis.A visual examination of the returned device confirmed that the crimp markings were visible on the balloon.No issues were noted with the balloon material.A visual examination found the stent was not returned with the device.No issues were noted with the tip of the device.A visual and tactile examination identified no issues along the length of the device.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16095500
• Report Number: 2124215-2022-54236
• Device Sequence Number: 12429516
• Product Code: NIO
• UDI-Device Identifier: 08714729392156
• UDI-Public: 08714729392156
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

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: 03/06/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0028998331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - 6X45 AND 7X45 DESTINATION SHEATH; GUIDE CATHETER - 6X45 AND 7X45 DESTINATION SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown