MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VENOUS WALLSTENT; STENT, ILIAC VEIN

Model Number	H74912044106870
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the guidewire became caught on the stent catheter.A 10mm x 68mm venous self-expanding wallstent and a 0.035 x 180 cm amplatz superstiff straight tip guidewire were selected for use in a recanalization procedure.The wallstent was loaded onto the amplatz guidewire.After the wire was placed within the stent delivery system, a burr was observed on the guidewire.The burr snagged and then damaged the stent catheter.New devices were used to complete the procedure.There were no patient complications.
Event or Problem Description
It was reported the guidewire became caught on the deployed stent.A 10mm x 68mm venous self-expanding wallstent and a 0.035 x 180 cm amplatz superstiff straight tip guidewire were selected for use in a recanalization procedure.The wallstent was loaded onto the amplatz guidewire.After the wire was placed within the stent delivery system, a burr was observed on the guidewire.The burr snagged and then damaged the stent catheter.New devices were used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the venous wallstent was received with the stent over reconstrained on the device and the tip withdrawn into the shaft.A visual and tactile examination found the blue outer shaft of the device to be separated exposing the black inner shaft at approximately 25mm distal of the main t-valve.The shaft of the device was also found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.The stent of the device could not be deployed for examination due to severe shaft damage.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12775259
• Report Number: 2134265-2021-13831
• Device Sequence Number: 17037142
• Product Code: QAN
• UDI-Device Identifier: 08714729979425
• UDI-Public: 08714729979425
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 09/25/2022
• Device Model Number: H74912044106870
• Device Catalogue Number: H74912044106870
• Device Lot Number: 0026077138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male