MAUDE Adverse Event Report: NOVATE MEDICAL LTD SENTRY INFERIOR VENA CAVA (IVC) FILTER

Model Number	NM60-16-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Corresponding author and institution.This event was identified in a literature review.It was confirmed that this event was not previously reported to the manufacturer as a complaint.Follow up with the corresponding author was performed to obtain additional details including lot numbers, implanting instruction and relevant clinical information.Per the author, no further information was available.The lot number remains unknown; therefore a review of the device history records could not be performed.Based on the reported information and without event dates, a device malfunction was not reported nor confirmed.No further action is required.This mdr is being reported due to the seriousness of the complication.The sentry ifu states "if clot is identified in the sentry ivc filter prior to bioconversion, the patient should be managed according to local clinical guidelines.Treatment modalities depend upon a number of variables including the size of the clot, patient symptoms and physician preferences.Potential options include watchful waiting, anticoagulation, thrombolysis, thrombectomy, and placement of a second, more cranial ivc filter." in addition, the ifu states potential ivc filter complications including caval thrombosis, stenosis or occlusion.
Event or Problem Description
This event is derived from a literature review of filter-related complications presented in "inferior vena cava filter evaluation and management for the diagnostic radiologist: a comprehensive review including inferior vena cava filter-related complications and preserve trial filters" article by ahmed et al 2019.In filter-associated complications section, a coronal contrast enhanced computed tomography image demonstrates acute thrombotic occlusion of a btg sentry convertible filter.Thrombus is also noted extending cephalad to the conical apex of the filter.

• Brand Name: SENTRY INFERIOR VENA CAVA (IVC) FILTER
• Common Device Name: SENTRY INFERIOR VENA CAVA (IVC) FILTER
• Manufacturer (Section D): NOVATE MEDICAL LTD; block 11; galway technology park; galway, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9316015
• Report Number: 3014726918-2019-00002
• Device Sequence Number: 19460449
• Product Code: DTK
• UDI-Device Identifier: 05391529380069
• UDI-Public: 05391529380069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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 Model Number: NM60-16-28
• Device Catalogue Number: NM60-16-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/13/2019
• 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: Other