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

Model Number 20201

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The target lesion was located in the left subclavian artery.A 7.0mm x 19mm x 150cm express vascular sd stent balloon was advanced for treatment.However, during the procedure, the stent was delivered into the 6f long sheath along 18 guide wire, and a resistance was felt.It was found out that the stent was dislodged inside the introducer sheath.The delivery shaft was withdrawn first, and the stent was withdrawn together with the sheath.The procedure was completed with another of the same device.There were no complications reported and the patient status was stable.

• Brand Name: EXPRESS VASCULAR SD
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19197486
• MDR Text Key: 341417467
• Report Number: 2124215-2024-23707
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20201
• Device Catalogue Number: 20201
• Device Lot Number: 0032105206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 51 KG