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

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.

Manufacturer Narrative

The device was not returned for analysis.Angiographical images provided by the customer revealed that the device had perforated the vessel constraining the distal crown of the filter.The user advanced the sheath for repositioning without the support of a guidewire before deploying the filter.Per the ifu "reinsert the dilator and guidewire into the introducer sheath for any advancement or repositioning of the introducer to avoid kinking.Remove the dilator and guidewire following repositioning." there is no evidence that the device failed to meet specifications.

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.

• Brand Name: SENTRY IVC FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): NOVATE MEDICAL; block 11 galway technology prk; parkmore; galway H91 V E0H; EI H91 VE0H
• MDR Report Key: 10382129
• MDR Text Key: 202181671
• Report Number: 2134265-2020-10734
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 05391529380069
• UDI-Public: 05391529380069
• Combination Product (y/n): N
• PMA/PMN Number: K181202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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 Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: NM60-16-28
• Device Catalogue Number: NM60-16-28
• Device Lot Number: 0000003657
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR