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 08/05/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The patient underwent stent implantation.The 80% stenosed target lesion was located in a non-tortuous and non-calcified iliac vein.A 12x60/8fr 75cm wallstent uni (wallstent endoprosthesis).However, upon unpacking, it was noticed that there was a crease at the middle portion of the stent.It could not be deploy and was removed completely.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The patient underwent stent implantation.The 80% stenosed target lesion was located in a non-tortuous and non-calcified iliac vein.A 12x60/8fr 75cm wallstent uni (wallstent endoprosthesis).However, upon unpacking, it was noticed that there was a crease at the middle portion of the stent.It could not be deploy and was removed completely.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) universit.Y e1 - initial reporter phone: (b)(6).Device evaluated by mfr.: a wallstent uni device was received for analysis.A visual and tactile examination identified that the outer sheath had multiple kinks along the length of the delivery system.The stainless-steel shaft was also noted to be damaged.The device was returned with the stent partially deployed.This concludes the product analysis.

• 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: 17672880
• MDR Text Key: 322536747
• Report Number: 2124215-2023-45393
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08714729203964
• UDI-Public: 08714729203964
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: 0030020415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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: 60 YR
• Patient Sex: Male