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

Model Number	20226
Medical Device Problem Codes	Material Separation (1562); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent did not fully deploy, and balloon detachment occurred.The patient presented with peripheral artery disease (pad).The stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, the stent did not fully deploy when the physician removed the stent delivery system (sds).The balloon of the sds tore about leaving the balloon in the body.The physician then gained access on the other side and was able to remove the balloon from the body with a snare and the procedure was completed.There were no patient complications nor injuries reported and patient fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr.: express-b-i ld, pmtd.7.0x30x75cm, was returned for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.Blood noted inside the balloon is evidence of a device leak.A leak test could not be carried out due to a complete separation of the shaft.No other issues were noted with the balloon.The device was received with stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual examination found the tip of the device to be severely damaged.This type of damage is consistent with the device encountering resistance when crossing/advancing the lesion.A visual and tactile examination found the shaft of the device to be completely separated at the proximal balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.
Event or Problem Description
It was reported that stent did not fully deploy, and balloon detachment occurred.The patient presented with peripheral artery disease (pad).The stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, the stent did not fully deploy when the physician removed the stent delivery system (sds).The balloon of the sds tore about leaving the balloon in the body.The physician then gained access on the other side and was able to remove the balloon from the body with a snare and the procedure was completed.There were no patient complications nor injuries reported and patient fully recovered.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16756006
• Report Number: 2124215-2023-15645
• Device Sequence Number: 17001437
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: 08714729579663
• 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: 2023
• 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): 05/24/2023

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: 12/01/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030638892
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown