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	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 75cm wallstent uni stent self-expanding was used for an iliac vein stenting.However, when the stent was deployed and flowered, they noticed that the tip of the stent did not look correct and appeared distorted.Attempts were made to redeploy the tip of the stent and recapture it, but still looked the same.The device was removed intact, and the procedure was completed with another of the same device.There were no incidents or patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a 75cm wallstent uni stent self-expanding was returned for analysis.The device was received with the stent in the correct position on the delivery system.The stent was successfully deployed by the investigator without issue.A visual examination of the stent identified no damage.A visual examination of the sheath of the device identified no damage.A visual examination of the stent holder cup or tip of the device identified no damage or issue.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and mildly calcified iliac artery.A 75cm wallstent uni stent self-expanding was used for an iliac vein stenting.However, when the stent was deployed and flowered, they noticed that the tip of the stent did not look correct and appeared distorted.Attempts were made to redeploy the tip of the stent and recapture it, but still looked the same.The device was removed intact, and the procedure was completed with another of the same device.There were no incidents or patient complications reported.

• 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: 17966840
• Report Number: 2124215-2023-57658
• Device Sequence Number: 6620879
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 07/23/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0032076333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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 Race: White