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

Model Number 20226

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 283489885
• Report Number: 2134265-2021-16399
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female