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

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the lower limb vein.A 12x90/8fr 75cm wallstent uni was advanced for treatment.However, during the procedure, the stent strut was kinked and could not be continued when it was deployed at 40%.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: 12x90/8fr uni plus halo 75cm was received for analysis.A visual examination found the outer blue shaft to be kinked at approximately 100mm proximal of the distal tip.When the investigator deployed the stent of the device, the inner shaft was also found to be kinked at approximately 25mm distal of the proximal markerband.It can be confirmed that before deploying the stent the inner shaft kink would have been located at the same site as the outer shaft kink.This type of damage is consistent with excessive force being applied to the device.The device was received with the stent in the correct position on the device.The investigator successfully deployed the stent without resistance or issue experienced.A visual examination found the deployed stent to be kinked at approximately 25mm distal of the proximal stent wires.The stent wires were also found to be fractured at the site of the kink.It can be confirmed that the kink on the stent would have been located at the same site as the outer and inner shaft kinks when the stent was mounted on the delivery system.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified no damage or issues with the delivery system or tip of the device that could potentially have contributed to the complaint incident.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the lower limb vein.A 12x90/8fr 75cm wallstent uni was advanced for treatment.However, during the procedure, the stent strut was kinked and could not be continued when it was deployed at 40%.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12550016
• Report Number: 2134265-2021-12265
• Device Sequence Number: 11038126
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 01/13/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026630710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 57