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	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left iliac vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during the procedure, it was noted under x-ray that the metal wires of the stent were broken and the device could not be implanted.The procedure was completed with another of same device.There were no patient complications reported and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1- initial reporter phone: (b)(4).
Additional Manufacturer Narrative
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 sheath was damaged.The stent was returned unsheathed.The investigator was unable to deploy the stent due to the damaged sheath.A visual and tactile examination identified that the tip section was partially deployed for approximately 5mm.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the left iliac vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during the procedure, it was noted under x-ray that the metal wires of the stent were broken and the device could not be implanted.The procedure was completed with another of same device.There were no patient complications reported and the patient condition following the procedure was stable.It was further reported that the target lesion was 60-70% stenosed, non-calcified and non-tortuous.It was noted that the stent struts were lifted and not broken as previously reported.The device was completely removed from the patient with the stent not fully reconstrained.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16876542
• Report Number: 2124215-2023-20964
• Device Sequence Number: 20647076
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 07/05/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0029714704
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• 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: 65 YR
• Patient Sex: Female