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

Model Number	H74912044166070
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Chest Pain (1776); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event estimated using date article was received for publication.Khalid mo, moskovits n, frankel ra, et al.Venous stent migrating to the right heart causing severe regurgitation.Journal of investigative medicine high impact case reports.2020;8.Doi:10.1177/2324709620974220.
Event or Problem Description
It was reported via literature article that stent migration occurred.A 16x60mm venous wallstent was implanted in the left iliac vein 10 months prior to presentation.Two days after the procedure, the patient went to a hospital complaining of chest pain.Transesophageal echocardiography was performed at the other institution and showed an "unclear echo density in the right atrium, which was suspected to be an artifact." a coronary angiogram showed nonobstructive coronary artery disease.Based on the previous report, a transthoracic echocardiography was ordered that showed a foreign body in the right atrial cavity extending across the tricuspid valve (tv).A transesophageal echocardiography was performed, which showed a dislodged vascular stent in the right atrium measuring 5.5 x 1.6 cm.The stent was impinging on the tv, causing severe tricuspid regurgitation.The patient was admitted to cardiology service and placed on heparin for anticoagulation.Computed tomography of the chest reported a tubular radiopaque density, in the right atrium, partially extending into the right ventricle.Following a multidisciplinary meeting involving interventional cardiology, vascular surgery, and cardiothoracic surgery, percutaneous extraction of the stent was attempted under transesophageal echocardiography guidance; however, it was firmly adhered to the tv and opposing the right atrial wall.Consequently, the patient underwent open stent extraction, during which the stent was found to be adherent to the tv and the right atrial wall.The stent was extracted via open thoracotomy.The extracted stent measured 6cm in length with white tissue observed on it, which was noted to be part of the tv endothelium.The patient required tv replacement and was discharged in a stable condition.

• 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: 19028642
• Report Number: 2124215-2024-18833
• Device Sequence Number: 8187302
• Product Code: QAN
• UDI-Device Identifier: 08714729979579
• UDI-Public: 08714729979579
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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 Model Number: H74912044166070
• Device Catalogue Number: H74912044166070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male