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

Model Number	NM60-16-28
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616); Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Code Available (3191)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2020-10734
• Device Sequence Number: 2186173
• Product Code: DTK
• UDI-Device Identifier: 05391529380069
• UDI-Public: 05391529380069
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 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
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/10/2020
• 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: 65 YR