MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removal and tip detachment occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified bifurcation of the right iliac vein.An 8.0x40x135 cm express ld stent was advanced for treatment.The balloon was inflated to 8 atm for 30 seconds and the stent was deployed.After the stent was deployed, multiple attempts to pull negative on the balloon were performed to ensure the balloon was deflated.When the physician pulled the catheter out with difficulty, the proximal tip of the balloon snapped off inside the sheath.The sheath was then pulled out with the detached pieces of the balloon in it and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: express ld iliac / biliary pmtd 8.0x40x135 cm stent was received for analysis.The device was received in two sections due a complete separation of the shaft.A visual examination of the returned device confirmed that the stent had been deployed from the balloon.Due to a complete break of the shaft, a leak test could not be carried out.No issues were noted with the balloon material.A visual examination found the stent to have been deployed from the balloon material.The stent was not returned as it was implanted in the patient.No issues were noted with the device's tip.A visual and tactile examination identified a complete break of the shaft located at the proximal balloon sleeve.The shaft was also found to be severely damaged/stretched at more than one location.The damage to the shaft most likely occurred due to excessive force being applied on withdrawal through the sheath.No other issues were noted with the shaft.
Event or Problem Description
It was reported that difficulty removal and tip detachment occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderate to severely calcified bifurcation of the right iliac vein.An 8.0x40x135 cm express ld stent was advanced for treatment.The balloon was inflated to 8 atm for 30 seconds and the stent was deployed.After the stent was deployed, multiple attempts to pull negative on the balloon were performed to ensure the balloon was deflated.When the physician pulled the catheter out with difficulty, the proximal tip of the balloon snapped off inside the sheath.The sheath was then pulled out with the detached pieces of the balloon in it and the procedure was completed.There were no patient complications 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13195056
• Report Number: 2134265-2021-16399
• Device Sequence Number: 6046154
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/20/2022

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: 09/02/2024
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0027960339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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
• Patient Age: 85 YR
• Patient Sex: Female