MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20212

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified left leg vessel.An 8.0x60x135 cm express ld vascular stent was advanced for treatment.However, when the device was inserted into the 7f sheath, it would not fit and was stuck.When it was pulled out from the sheath, the front tip was bent.The procedure was completed with another ld express stent and no patient complications were reported.

Manufacturer Narrative

B5 describe event or problem: updated to include new information obtained.

Event Description

It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified left leg vessel.An 8.0x60x135 cm express ld vascular stent was advanced for treatment.However, when the device was inserted into the 7f sheath, it would not fit and was stuck.When it was pulled out from the sheath, the front tip was bent.The procedure was completed with another ld express stent and no patient complications were reported.It was further reported that the target lesion was located in common iliac artery.It was noted the stent strut was bent and was not broken into pieces.

Manufacturer Narrative

Express-vascular ld pmtd 8.0x60x135 cm was received for analysis.The indicated introducer sheath size for this express ld device as per express specification is a 7fr.The customer's sheath was not returned for analysis.During analysis the investigator was unable to advance the device through a boston scientific 7fr sheath due to stent damage.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent crimped in the correct location on the balloon.The first to rows of proximal stent struts were noted to be damaged.This type of damage is consistent with excessive force being applied to the device.No issues were noted with the tip of the device.A visual and tactile examination identified no kinks or issues with the shaft of the device.

Event Description

It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified left leg vessel.An 8.0x60x135 cm express ld vascular stent was advanced for treatment.However, when the device was inserted into the 7f sheath, it would not fit and was stuck.When it was pulled out from the sheath, the front tip was bent.The procedure was completed with another ld express stent and no patient complications were reported.It was further reported that the target lesion was located in common iliac artery.It was noted the stent strut was bent and was not broken into pieces.

• Brand Name: EXPRESS LD VASCULAR
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17271271
• MDR Text Key: 318578697
• Report Number: 2124215-2023-35047
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0031346103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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