MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number 26280

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

H6 - device codes: updated from material deformation to material integrity problem.

Event Description

It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that 50% stenosed target lesion was located in the severely calcified and mildly tortuous femoral artery and the obvious crease was located in the shaft.

Manufacturer Narrative

H6 - device codes: updated from material deformation to material integrity problem.Device evaluated by mfr: the device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection found the sheath of the device to be kinked at approximately 30mm proximal of the tip.This type of damage is consistent with excessive force being applied to the delivery system.

Event Description

It was reported that obvious crease was found in the stent.The target lesion was located in the femoral artery.An 16x90/9fr wallstent uni was advanced for treatment.However, after balloon dilatation, an apparent crease in the stent was found when it was extracted.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that 50% stenosed target lesion was located in the severely calcified and mildly tortuous femoral artery and the obvious crease was located in the shaft.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• 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: 18660324
• MDR Text Key: 334775150
• Report Number: 2124215-2024-06878
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152842
• 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,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030979812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 67 KG