MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 43175

Device Problems Break (1069); Positioning Problem (3009)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2019

Event Type  Injury  

Event Description

On (b)(6) 2011 the patient underwent placement of a greenfield vena cava filter.On 02 (b)(6) 2019, a computed tomography (ct) scan revealed a fractured filter, tilt and perforation.The proximal tip of the filter is located 9-10mm below the inferior margin of the right renal vein.The proximal apex of the filter is tilted anteriorly.Anterior margin of the apex of the filter attaching to the anterior wall of the inferior vena cava (ivc).Distal tips of all the peripheral struts of the filter appear to extend beyond the margins of the ivc in the axial plane.Right anterolateral strut at 10-11 oclock appears to course along the anterior ivc margin for at least 1cm.Anterior strut at 12 oclock also appears to course anterior to the ivc margin for at least 1.5cm.Left lateral strut at 3 oclock appears to course extraluminal for at least 2.5cm., distal tip noted close to the right posterolateral margin of the aorta, though not clearly invading the aorta.2 adjacent right posterolateral struts at 9 oclock and 8 oclock appear to be at least partially extraluminal distally for at least 5mm.This strut appears to be bent slightly posterolaterally towards the right, originally originating at the 6 oclock position.No obvious fracture of these struts.There are several clustered linear metallic foci/fragments in the left abdomen, anterior to the left kidney, which may represent surgical clips, which should be correlated clinically, as a piece of a fractured strut could potentially migrate into this region.

Event Description

On (b)(6) 2011 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computated tomography (ct) scan revealed a fractured filter, tilt and perforation.The proximal tip of the filter is located 9-10mm below the inferior margin of the right renal vein.The proximal apex of the filter is tilted anteriorly.Anterior margin of the apex of the filter attaching to the anterior wall of the inferior vena cava (ivc).Distal tips of all the peripheral struts of the filter appear to extend beyond the margins of the ivc in the axial plane.Right anterolateral strut at 10-11 oclock appears to course along the anterior ivc margin for at least 1cm.Anterior strut at 12 oclock also appears to course anterior to the ivc margin for at least 1.5cm.Left lateral strut at 3 oclock appears to course extraluminal for at least 2.5cm., distal tip noted close to the right posterolateral margin of the aorta, though not clearly invading the aorta.2 adjacent right posterolateral struts at 9 oclock and 8 oclock appear to be at least partially extraluminal distally for at least 5mm.This strut appears to be bent slightly posterolaterally towards the right, originally originating at the 6 oclock position.No obvious fracture of these struts.There are several clustered linear metallic foci/fragments in the left abdomen, anterior to the left kidney, which may represent surgical clips, which should be correlated clinically, as a piece of a fractured strut could potentially migrate into this region.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9944168
• MDR Text Key: 187891708
• Report Number: 2134265-2020-04848
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• Combination Product (y/n): N
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0014253816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/09/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR