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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The patient presented with advanced lung cancer with severe space-occupying lesion.Angiography was performed which revealed an over 85% stenosed target lesion located in the severely tortuous superior vena cava.The patient was placed in supine position and puncture was performed through the right femoral artery with a 10f puncture sheath.A 0.035 amplatz guidewire was then advanced to the lesion and pre-dilatation was performed with a 6x100, 8x100, and 12x80 mustang balloon catheters.Due to severe tortuosity of the blood vessel, the balloon retracted severely after crossing.Subsequently, a 14x90/9fr 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after multiple attempts to cross the lesion, the stent could not be deployed.The device was removed and it was noted that the cover of the stent and the stent itself were damaged.Deployment was tested outside the patient body but there was difficulty encountered.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that stent damage occurred.The patient presented with advanced lung cancer with severe space-occupying lesion.Angiography was performed which revealed an over 85% stenosed target lesion located in the severely tortuous superior vena cava.The patient was placed in supine position and puncture was performed through the right femoral artery with a 10f puncture sheath.A 0.035 amplatz guidewire was then advanced to the lesion and pre-dilatation was performed with a 6x100, 8x100, and 12x80 mustang balloon catheters.Due to severe tortuosity of the blood vessel, the balloon retracted severely after crossing.Subsequently, a 14x90/9fr 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after multiple attempts to cross the lesion, the stent could not be deployed.The device was removed and it was noted that the cover of the stent and the stent itself were damaged.Deployment was tested outside the patient body but there was difficulty encountered.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a 14x90/9fr uni plus 75cm was received for analysis.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent without issue.A visual examination identified kinking to the deployed stent.The outer sheath was found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.The inner sheath was found to be kinked at the same location as the outer sheath.This type of damage is consistent with excessive force being applied to the device.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent without issue.A visual examination identified kinking to the deployed stent at the same location as the sheath when it was mounted on the delivery system.A visual examination identified no damage or issues with the stent holder/cup or 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16742988
• Report Number: 2124215-2023-14994
• Device Sequence Number: 5435491
• 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): 06/02/2023

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: 04/28/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0029310276
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.035 AMPLATZ; GUIDEWIRE: 0.035 AMPLATZ
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 59 KG