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

Model Number	26280
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that partial stent deployment occurred.The patient presented with may thurner syndrome.The target lesion was located in the non-tortuous and non-calcified left iliac vein.A 22x70/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.Upon deployment attempts, only half of the stent was deployed and would not go any further.It was noted that the device was stuck and was not reconstrained during removal.There was some initial resistance while getting the distal struts off of the vessel and while the stent was in the sheath being removed.The device was removed intact, and the guidewire was able to be removed from the stent once outside the patient.The procedure was completed with a new wallstent and was implanted successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: 22x70/10fr uni plus 75cm was received for analysis.The device was received with the stent partially deployed on the delivery system.The investigator successfully fully deployed the stent without issue.A visual examination identified damage no damage to the deployed stent.A visual examination identified damage no damage to the sheath of the device.A visual examination identified no damage or issues with the stent holder/cup or tip of the device.
Event or Problem Description
It was reported that partial stent deployment occurred.The patient presented with may thurner syndrome.The target lesion was located in the non-tortuous and non-calcified left iliac vein.A 22x70/10fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.Upon deployment attempts, only half of the stent was deployed and would not go any further.It was noted that the device was stuck and was not reconstrained during removal.There was some initial resistance while getting the distal struts off of the vessel and while the stent was in the sheath being removed.The device was removed intact, and the guidewire was able to be removed from the stent once outside the patient.The procedure was completed with a new wallstent and was implanted successfully.No patient complications were 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: 17239261
• Report Number: 2124215-2023-32354
• Device Sequence Number: 6969958
• Product Code: JCT
• UDI-Device Identifier: 08714729204145
• UDI-Public: 08714729204145
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/20/2023

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: 10/17/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028214955
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2021
• 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 Sex: Unknown
• Patient Race: White