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

Model Number	26280
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that stent positioning difficulties were encountered.The target lesion was located in the lower limbs.A 16x90/9fr uni plus 75cm wallstent uni was advanced to treat the lesion.During the procedure, it was noted that the stent jumped forward too much after withdrawal, making it unable to cover the site of the thrombus.The device was directly removed replaced with a different model to complete the procedure.There were no complications reported, and the patient's status was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device was returned to the manufacturer: the wallstent device was returned with the stent in correct position on the delivery system.No damage or issues were noted with the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent positioning difficulties were encountered.The target lesion was located in the lower limbs.A 16x90/9fr uni plus 75cm wallstent uni was advanced to treat the lesion.During the procedure, it was noted that the stent jumped forward too much after withdrawal, making it unable to cover the site of the thrombus.The device was directly removed and replaced with a different model to complete the procedure.There were no complications reported, and the patient's status was stable.It was further reported that the stent was displaced upon withdrawal of the delivery system.The stent was removed without being re-constrained.

• 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: 18517899
• Report Number: 2124215-2023-76003
• Device Sequence Number: 6751304
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 01/09/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030819719
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG