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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENITI, INC. VICI
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VENITI, INC. VICI Back to Search Results
Model Number 26930
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  Injury  
Event Description
It was reported that the stent migrated to the heart leading to surgery.A vici self expanding stent was selected for a patient procedure to treat may-thurner syndrome.The procedure was completed without complications.However, at an undisclosed time, the stent migrated to the heart and the patient needed surgery.No further complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Date of event: event date was not reported and was approximated to (b)(6) 2021.Implant date: implant date was not reported and was approximated to (b)(6) 2021.
 
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Brand Name
VICI
Manufacturer (Section D)
VENITI, INC.
4025 clipper court
fremont CA 94538
Manufacturer (Section G)
VENITI, INC.
4025 clipper court
fremont CA 94538
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12956951
MDR Text Key281905472
Report Number2134265-2021-14649
Device Sequence Number1
Product Code QAN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26930
Device Catalogue Number26930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number92672766-FA
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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