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

Model Number	26280
Medical Device Problem Codes	Difficult to Flush (1251); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The patient underwent stent implantation of the 80% stenosed target lesion located in the severely tortuous and non-calcified superior vena cava.During the procedure, the guidewire and sheath were placed after the left femoral vein was punctured.The guidewire was replaced with a non-boston scientific guidewire in the inferior vena cava (ivc) after the lesion location was determined through angiography.Due to the stenosis at the lesion site, pre-dilation was performed with a mustang balloon 12*80.A 12x90/8fr, 75cm wallstent endoprosthesis stent was selected for use.There was slight resistance when flushing the stent.After the stent reached the lesion and half of the stent was deployed, great resistance occurred when withdrawing the outer sheath of the stent.The stent was recaptured and removed as a whole after multiple attempts.When pushing out the stent, outside the patient, it was found that the stent was kinked.A 12*90 wallstent was used instead, and after post-dilation with a balloon, the procedure was completed with good results.No complications were reported, and the patient was stable post-procedure.
Event or Problem Description
It was reported that stent damage occurred.The patient underwent stent implantation of the 80% stenosed target lesion located in the severely tortuous and non-calcified superior vena cava.During the procedure, the guidewire and sheath were placed after the left femoral vein was punctured.The guidewire was replaced with a non-boston scientific guidewire in the inferior vena cava (ivc) after the lesion location was determined through angiography.Due to the stenosis at the lesion site, pre-dilation was performed with a mustang balloon 12*80.A 12x90/8fr, 75cm wallstent endoprosthesis stent was selected for use.There was slight resistance when flushing the stent.After the stent reached the lesion and half of the stent was deployed, great resistance occurred when withdrawing the outer sheath of the stent.The stent was recaptured and removed as a whole after multiple attempts.When pushing out the stent, outside the patient, it was found that the stent was kinked.A 12*90 wallstent was used instead, and after post-dilation with a balloon, the procedure was completed with good results.No complications were reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The stent was fully constrained in the correct position on the delivery system.The investigator attached the returned device to a 10ml syringe and successfully flushed the delivery system and guidewire lumen without any issues experienced as per instructions indicated in the instruction for use (ifu).A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found the inner sheath of the device to be kinked at approximately 70mm proximal of the tip.No other issues were noted with the sheath.The stent was successfully deployed without issue.The stent was found to be kinked at the same location as the sheath when it was mounted on the device.No other issues were noted with the stent.

• 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: 19729575
• Report Number: 2124215-2024-42070
• Device Sequence Number: 8206846
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 08/25/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030029066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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 - AMPLATZ.; GUIDEWIRE - AMPLATZ.
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG