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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVATE MEDICAL SENTRY IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR

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NOVATE MEDICAL SENTRY IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number NM60-16-28
Device Problems Use of Device Problem (1670); Malposition of Device (2616); Difficult to Open or Close (2921)
Patient Problems Perforation of Vessels (2135); No Code Available (3191)
Event Date 07/09/2020
Event Type  Injury  
Event Description

It was reported that a patient was implanted with a sentry ivc filter for dvt through the right common femoral vein. A venogram was performed prior to placement. The device was deployed in the ivc, infra renal and the distal portion of the filter did not open as expected. The next day a cta was performed and revealed that the distal part of the filter was outside of the ivc. The patient is stable and the physician is planning possible intervention. It was further reported that this event was a result of use error and not device failure. The physician did not use a guidewire while advancing the sheath 3cm forward right before the filter was deployed. The movement of the sheath resulted in perforation of the ivc. Venogram imaging shows the top crown was constrained due to being extravascular. The patient was treated at a different institution where the filter was successfully explanted.

 
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Brand NameSENTRY IVC FILTER
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
NOVATE MEDICAL
block 11 galway technology prk
parkmore
galway H91 V E0H
EI H91 VE0H
Manufacturer (Section G)
NOVATE MEDICAL
block 11,galway technology prk
parkmore
galway H91 V E0H
EI H91 VE0H
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10382129
MDR Text Key202181671
Report Number2134265-2020-10734
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNM60-16-28
Device Catalogue NumberNM60-16-28
Device LOT Number0000003657
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/27/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/07/2020 Patient Sequence Number: 1
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