MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 26650

Device Problem Fracture (1260)

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

Event Date 09/27/2023

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Event Description

It was reported that stent fracture occurred which requires additional intervention.The target lesion was located in a mildly tortuous iliac vein.A 16 x 60mm x 75cm wallstent uni stent was advanced for treatment together with a balloon which is followed by angiographic control with contrast medium.However, fracture was observed in the proximal portion and was displaced from the initial site.So another stent was placed inside the wallstent to avoid complications.The patient was fully recovered.

• Brand Name: WALLSTENT-UNI ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 17951403
• MDR Text Key: 325899449
• Report Number: 2124215-2023-54299
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Model Number: 26650
• Device Catalogue Number: 26650
• Device Lot Number: 0028100433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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 Outcome(s): Required Intervention