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

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 14x90/9fr uni plus 75cm wallstent uni was selected for treatment in the iliac artery.When a second release of stent was done, it was noted that this device was deformed on the tip.The device was removed and replaced with another of the same product to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.The wallstent device was received by the manufacturer: a visual examination found the stent to be partially deployed on the delivery system.The distal stent wires were noted to be damaged.No issues were noted with the delivery system during analysis.The product record review confirmed that this is not a new failure type, and the risk is anticipated.
Event or Problem Description
It was reported that stent damage occurred.A 14x90/9fr uni plus 75cm wallstent uni was selected for treatment in the iliac artery.When a second release of stent was done, it was noted that this device was deformed on the tip.The device was removed and replaced with another of the same product to complete the procedure.There were no patient complications reported.It was further reported that the target lesion was of 60% stenosis and was moderately tortuous and severely calcified.The wallstent device was received by the manufacturer: a visual examination found the stent to be partially deployed on the delivery system.The distal stent wires were noted to be damaged.No issues were noted with the delivery system during analysis.The product record review confirmed that this is not a new failure type, and the risk is anticipated.

• 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: 18426869
• Report Number: 2124215-2023-74518
• Device Sequence Number: 7697730
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: 04/02/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0031357052
• 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: 12/09/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG