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

Model Number	26280
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent migration occurred requiring additional intervention.The 65% stenosed target lesion was located in the mildly tortuous and mildly calcified central vein of the superior vena cava.A stent was originally placed in the intended location, however it slipped into the atrium.A 20fr sheath was placed in the femoral vein, and a snare was used with guidewire.The guidewire crossed the stent structs and then the snare grabbed the guidewire and pulled the stent into the sheath, and then removed.The procedure was completed using with another of same device.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the wallstent uni was returned for analysis.A visual examination found the stent of the device to be fully deployed from the device.The stent was not returned for analysis.A visual and tactile inspection identified no kinks or damage to the delivery system.A visual examination identified no issues with the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent migration occurred requiring additional intervention.The 65% stenosed target lesion was located in the mildly tortuous and mildly calcified central vein of the superior vena cava.A stent was originally placed in the intended location, however it slipped into the atrium.A 20fr sheath was placed in the femoral vein, and a snare was used with guidewire.The guidewire crossed the stent structs and then the snare grabbed the guidewire and pulled the stent into the sheath, and then removed.The procedure was completed using with another of same device.No complications reported, and patient status was stable.It was further reported that a 14x60/9fr uni plus 75cm wallstent endoprosthesis was selected for use.Furthermore, the stent migrated immediately following its placement.The patient was diagnosed with post-thrombotic syndrome (pts) prior to the stent implantation.A complete occlusion was observed in the right brachiocephalic vein, and after gaining access, the stent was inserted.Digital subtraction angiography (dsa) was conducted, revealing the complete occlusion in the right brachiocephalic vein.A 12 mm balloon was utilized for pre-dilation.Although the exact dimensions of the vessel were unknown, the use of a 12 mm balloon for pre-dilation suggests that the stent should be of a similar size.Pre-stenotic vein dilation was noted, and no intravascular ultrasound (ivus) was employed.Both an 8 mm and a 12 mm balloon were used for pre-dilation prior to the stenting procedure, marking the first intervention for this condition.The implantation process encountered no complications.Upon initial deployment, the stent appeared to fully expand and conform to the vein walls, with no additional stents placed during the procedure.Although a balloon dilation was planned after the stent placement, the stent migrated during post-dilation.The migration was reported within five minutes of the stent's placement.The migrated stent was subsequently removed, and a 16 mm stent was inserted in its place, with the patient now in a stable condition.

• 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: 20321351
• Report Number: 2124215-2024-58716
• Device Sequence Number: 15490600
• Product Code: MAF
• UDI-Device Identifier: 08714729204008
• UDI-Public: 08714729204008
• 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): 10/31/2024

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: 06/18/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0031844275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male