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

Model Number	H74912044169070
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified common iliac vein.A 16x90x75cm venous wallstent self-expanding stent was selected for treatment.Upon unpacking, the packaging was noted to be damaged and the tip end of the body of the stent was noted to be bent.The wire was unable to advance through the device.The device was never introduced into the patient's body.The procedure was completed with a new stent.No patient complications were reported.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• 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: 19804753
• Report Number: 2124215-2024-41888
• Device Sequence Number: 12859236
• Product Code: QAN
• UDI-Device Identifier: 08714729979586
• UDI-Public: 08714729979586
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980033/S050
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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: 08/24/2025
• Device Model Number: H74912044169070
• Device Catalogue Number: H74912044169070
• Device Lot Number: 0032292456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/23/2024
• Date Device Manufactured: 08/25/2023
• 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 Sex: Female