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

Model Number 26280

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that removal difficulties and stent damage occurred.The target lesion was located in the iliac vein.A 16x90/9fr wallstent endoprosthesis was advanced for treatment along with the guidewire.However, the stent was stuck during deployment and was unable to be deployed nor withdrawn.The physician pulled out the delivery shaft, it was noted that the stent was elongated and deformed inside the patient.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: a 16x90/9fr uni plus 75cm was received for analysis.A visual examination found that the stent of the device had been deployed from the delivery system.The deployed stent was not returned for analysis.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no kinks or damage along the length of the device.

Event Description

It was reported that removal difficulties and stent damage occurred.The target lesion was located in the iliac vein.A 16x90/9fr wallstent endoprosthesis was advanced for treatment along with the guidewire.However, the stent was stuck during deployment and was unable to be deployed nor withdrawn.The physician pulled out the delivery shaft, it was noted that the stent was elongated and deformed inside the patient.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12591357
• MDR Text Key: 275213036
• Report Number: 2134265-2021-12552
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026651531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Weight: 56 KG