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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 14aug2024.It was reported that deployment failure occurred.The target lesion was located in the iliac vein.A 16x90/9fr 75cm wallstent endoprosthesis self-expanding stent was selected for use.During the procedure, the delivery shaft could not be advanced, and the stent could not be deployed.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.However, returned device analysis revealed a damage to the distal stent wires.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent fully constrained in the correct position on the device.The stent was successfully deployed without issue.A visual examination identified damage to the distal stent wires caused by severe kinking to the outer and inner sheath of the device.A visual and tactile examination found both the inner and outer sheath to be severely kinked at more than one location.The kinking was noted to have contributed to stent damage.A visual and tactile examination identified no damage or issues with the tip of the device.

• 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: 20168946
• Report Number: 2124215-2024-54782
• Device Sequence Number: 8137686
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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: 07/04/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0029702577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 64 KG