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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2023-45393
• Device Sequence Number: 6512944
• Product Code: MAF
• UDI-Device Identifier: 08714729203964
• UDI-Public: 08714729203964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male