MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENONO VENOUS STENT SYSTEM; STENT, ILIAC VEIN

Model Number	VENUM14160
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Venovo stent placed on (b)(6) 2020 in facility "a".On (b)(6) 2020: patient in ed c/o sob.Discharged and readmitted on (b)(6) 2020 with sob and chest pain.Ct of abdomen and pelvis reported in body of note "partially imaged stent in the right atrium." however, this was not indicated under impression / findings.Patient was discharged asymptomatic for several months.Experienced sob and chest pain on and off for several weeks.A 2d echocardiogram on (b)(6) 2021 for chf revealed stent in the right atrium.Migration of the stent confirmed by fluoroscopy on (b)(6) 2021.Admitted to "facility b" on (b)(6) 2021 for stent removal.Stent removed on (b)(6) 2021.Per operative report, the stent extended into the svc and ivc and was embedded in the cardiac tissue.The device was extracted in multiple pieces.Remaining stent extracted in segments after dissection from the intracardiac tissue.Patient was admitted to cicu post op.After a hospital and skilled nursing stay, patient was discharge on (b)(6) 2021.As his primary care giver, it is unknown if this event was reported.Learned today that manufacturer recalled the stent that was placed in patient.Fda safety report id# (b)(4).

• Brand Name: VENONO VENOUS STENT SYSTEM
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 12336943
• Report Number: MW5103309
• Device Sequence Number: 3821403
• Product Code: QAN
• UDI-Device Identifier: 00801741103476
• UDI-Public: (01)00801741103476(17)220327(10)
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2022
• Device Model Number: VENUM14160
• Device Catalogue Number: VENUM14160
• Device Lot Number: ANEQ5002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 184