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

Model Number	26280
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent migrated and was deformed.On (b)(6) 2018 a 24mm x 4.5cm wallstent was deployed; however, during dilation, the stent migrated caudally on the guidewire into the right atrium.Left common femoral and a second right common femoral venous access was obtained.The migrated stent was manipulated using multiple techniques including: manipulation with a balloon, snare capture, and use of endobronchial forceps.The stent was ultimately manipulated into the infrarenal inferior vena cava and subsequent venography demonstrated high velocity antegrade flow without thrombus or occlusion.While repositioning the stent with forceps, a corner of the stent was manipulated bending some wires at the caudal end of the stent.Postoperatively, on june 8, 2018, the patient reported shortness of breath and was prescribed cromolyn."oozing" was also noted at the groin puncture site after the case, for which dressings were frequently changed and pressure was applied with a sandbag.
Event or Problem Description
It was reported that the stent migrated and was deformed.On (b)(6) 2018, the patient underwent bilateral innominate venography, superior vena cava venography, pressure measurements, angioplasty and stenting for superior vena cava syndrome.Local anesthesia was administered.The intended stent implant location was the superior vena cava.A 24mm x 4.5cm wallstent was deployed; however, during dilation, the stent migrated caudally on the guidewire into the right atrium.Left common femoral and a second right common femoral venous access was obtained.The migrated stent was manipulated using multiple techniques including: manipulation with a balloon, snare capture, and use of endobronchial forceps.The stent was ultimately manipulated into the infrarenal inferior vena cava and subsequent venography demonstrated high velocity antegrade flow without thrombus or occlusion.While repositioning the stent with forceps, a corner of the stent was manipulated bending some wires at the caudal end of the stent.Postoperatively, on (b)(6) 2018, the patient reported shortness of breath and was prescribed cromolyn."oozing" was also noted at the groin puncture site after the case, for which dressings were frequently changed and pressure was applied with a sandbag.
Additional Manufacturer Narrative
B5: describe event or problem was corrected with additional details, including the intended implant location.

• 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: 14622393
• Report Number: 2134265-2022-06444
• Device Sequence Number: 4949369
• Product Code: JCT
• UDI-Device Identifier: 08714729204169
• UDI-Public: 08714729204169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 03/08/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0020378513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Unknown