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

Model Number	26280
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was difficult to remove.Vascular access was obtained via the femoral vein puncture.The 50% stenosed target lesion was located in a mildly tortuous and moderately calcified artery.A 16mm x 90mm x 75cm wallstent endoprosthesis with the unistep plus delivery system was advanced for treatment.During the procedure, a balloon was expanded and then the stent was released but resistance was encountered.The stent was less than 50% deployed.Upon withdrawal, resistance was encountered again, and the tip of the stent was found loose.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that the stent was difficult to remove.Vascular access was obtained via the femoral vein puncture.The 50% stenosed target lesion was located in a mildly tortuous and moderately calcified artery.A 16mm x 90mm x 75cm wallstent endoprosthesis with the unistep plus delivery system was advanced for treatment.During the procedure, a balloon was expanded and then the stent was released but resistance was encountered.The stent was less than 50% deployed.Upon withdrawal, resistance was encountered again, and the tip of the stent was found loose.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The stent was partially deployed on the delivery system.A visual examination found the distal stent wires to be damaged.Despite the damage to the stent the investigator successfully re-constrained the stent without issue.No other issues were noted with the stent of the device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection found the inner sheath of the device to be severely kinked at the distal markerband.This type of damage is consistent with excessive force being applied to the delivery system.

• 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: 19033875
• Report Number: 2124215-2024-16321
• Device Sequence Number: 12808772
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 02/02/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030979812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 78 KG