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

Model Number VENUM14160

Device Problems Entrapment of Device (1212); Nonstandard Device (1420); Migration (4003)

Patient Problems Chest Pain (1776); Dyspnea (1816); Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2021

Event Type  Injury  

Event 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
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 12336943
• MDR Text Key: 267291434
• Report Number: MW5103309
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103476
• UDI-Public: (01)00801741103476(17)220327(10)
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 184