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

Model Number 20212

Device Problems Premature Activation (1484); Difficult to Advance (2920)

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

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device analysis: a visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.Visual examination also revealed that the stent was positioned in the correct location on the balloon with no evidence of damage or any other issues noted.During analysis, the investigator successfully advanced the device through an 7f boston scientific guide sheath without any resistance or issues noted.No other issues were noted during product analysis.

Event Description

It was reported that stent partial deployment occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified subclavian artery.A 9.0x30x135 cm express ld vascular stent was used.During the delivery of the stent, the physician encountered resistance between the delivery system and the unknown vascular sheath.The resistance intensified as the physician continued to advance, and the stent was partially deployed prior to reaching the target lesion.The stent and delivery system were removed, and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Device evaluated by mfr.: an express ld device was received for analysis.The recommended introducer sheath size for this express ld device is an 7fr.During analysis the investigator successfully advanced the device through an 7fr boston scientific guide without any resistance or issues noted.The guide used by the customer was not returned for analysis.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 positioned in the correct location on the balloon with no evidence of damage or any other issues noted.No issues were noted with the tip of the device.

Event Description

It was reported that stent partial deployment occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified subclavian artery.A 9.0x30x135 cm express ld vascular stent was used.During the delivery of the stent, the physician encountered resistance between the delivery system and the unknown vascular sheath.The resistance intensified as the physician continued to advance, and the stent was partially deployed prior to reaching the target lesion.The stent and delivery system were removed, and the procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further reported that the stent system was pulled out as a whole without using other devices.

• 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: 17209542
• MDR Text Key: 317941060
• Report Number: 2124215-2023-32077
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/17/2023

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: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0029975899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 60 KG