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

Model Number 26650

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Activation Failure (3270)

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

Event Date 07/19/2022

Event Type  Injury  

Event Description

It was reported that stent damage and partial deployment occurred.Vascular access was obtained via the femoral artery.The 60% stenosed, 40x18mm target lesion was located in a non-tortuous and mildly calcified vessel.After a 0.035 x 260cm amplatz super stiff guidewire crossed the lesion, pre-dilatation was performed with a 18mm x 20mm balloon catheter.A 22 x 45mm x 75cm wallstent-uni endoprosthesis stent was advanced, however, the stent did not fully deploy.Even after post -dilatation with a 22mm x 40mm balloon catheter, the proximal end of the stent was still not fully opened and proximal stent edge compression occurred.The physician used another stent to keep the wallstent open and the procedure was completed.No patient complications were reported and the patient status was stable.

Manufacturer Narrative

(b5) describe event or problem- correction to the information previously reported.(h6) device codes: corrected from activation, positioning or separation problem to activation failure including expansion failures.

Event Description

It was reported that stent damage and stent expansion failure occurred requiring additional intervention.Vascular access was obtained via the femoral artery.The 60% stenosed, 40x18mm target lesion was located in a non-tortuous and mildly calcified vessel.After a 0.035 x 260cm amplatz super stiff guidewire crossed the lesion, pre-dilatation was performed with an 18mm x 20mm balloon catheter.A 22 x 45mm x 75cm wallstent-uni endoprosthesis stent was advanced, however, the stent did not fully deploy.Even after post -dilatation with a 22mm x 40mm balloon catheter, the proximal end of the stent was still not fully opened and proximal stent edge compression occurred.The physician used another stent to keep the wallstent open and the procedure was completed.No patient complications were reported and the patient status was stable.

• Brand Name: WALLSTENT-UNI ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 15319263
• MDR Text Key: 298867617
• Report Number: 2124215-2022-31552
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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: 08/31/2023
• Device Model Number: 26650
• Device Catalogue Number: 26650
• Device Lot Number: 0027936577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male