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

Model Number 26280

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The target lesion was located in the lower extremity vein.A 12x90/8fr 75cm wallstent uni stent was advanced to treat the lesion.However, during the procedure despite of many attempts, it was failed to deploy, and it was noticed that the stent was kinked.The procedure was completed with a new stent.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that stent damage occurred.The target lesion was located in the lower extremity vein.A 12x90/8fr 75cm wallstent uni stent was advanced to treat the lesion.However, during the procedure despite of many attempts, it was failed to deploy, and it was noticed that the stent was kinked.The procedure was completed with a new stent.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion was located in the mildly tortuous lower extremity vein, and the device was simply pulled out from the patient.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: a 12x90/8fr uni plus halo 75cm was received for analysis.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent without issue.A visual examination identified no damage or issues with the deployed stent.The shaft was found to be kinked at approximately 280mm distal of the main t-valve.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no damage or issues with the stent holder/cup or tip of the device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16702580
• MDR Text Key: 313239751
• Report Number: 2124215-2023-15387
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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: 0030067740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 72 KG