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	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the two stents were compressed, and an additional procedure was performed with the intention to open them.Two wallstent endoprosthesis stents were selected for use and were implanted.Over five years later, the patient underwent a medical intervention to open the stents.The physician noted that the stents were fully incorporated into the vein wall, and a wire was unable to cross into the inferior vena cava from the right common iliac vein.Additionally, the right iliac stent was being compressed by the left iliac stent.The patient was informed by the physician that a third physician would need to be consulted for further treatment options.There were no additional adverse consequences reported for the patient.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16504599
• Report Number: 2124215-2023-10458
• Device Sequence Number: 3301478
• Product Code: JCT
• UDI-Device Identifier: 08714729204114
• UDI-Public: 08714729204114
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2018
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0019885030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WALLSTENT ENDOPROSTHESIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown