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

Model Number 20226

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the superficial femoral artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, the device was caught on the sheath and the stent was defective.Subsequently, another 7.0x30x135cm express ld stent was advanced.The second device was also caught on the sheath and defective.Both devices were retrieved, and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.The target lesion was located in the superficial femoral artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, the device was caught on the sheath and the stent was defective.Subsequently, another 7.0x30x135cm express ld stent was advanced.The second device was also caught on the sheath and defective.Both devices were retrieved, and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: this express ld device was received for analysis.The balloon was received tightly folded which indicates it had not been subjected to positive pressure.The stent was pushed over the proximal markerband and proximal balloon bond and part of shaft.The stent was slightly expanded due to the breadth of the proximal balloon bond.No damage or issues were noted with balloon material that could potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination of the device identified no issues with the tip that could have contributed to the complaint incident.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16109468
• MDR Text Key: 308361405
• Report Number: 2124215-2022-54604
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• 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: 0030216595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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