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

Model Number 43335

Device Problems Defective Device (2588); Material Deformation (2976); Positioning Problem (3009); Migration (4003)

Patient Problem Perforation (2001)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Partial lot number of 6864237 was reported.

Event Description

On (b)(6) 2004, the patient the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed a mesenteric perforation, device tilt, and strut bending.There were 13 degrees of left lateral tilt and 12 degrees of posterior tilt.Several of the struts appeared bent without fracture.One strut perforated 3mm beyond the inferior vena cava (ivc) wall and another strut perforated 2mm beyond the ivc wall.On (b)(6) 2020, the filter was removed as it was migrating towards the kidney.The filter was intact upon removal.

Event Description

On (b)(6) 2004, the patient the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan revealed a mesenteric perforation, device tilt, and strut bending.There were 13 degrees of left lateral tilt and 12 degrees of posterior tilt.Several of the struts appeared bent without fracture.One strut perforated 3mm beyond the inferior vena cava (ivc) wall and another strut perforated 2mm beyond the ivc wall.On (b)(6) 2020, the filter was removed as it was migrating towards the kidney.The filter was intact upon removal.

• 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: 9933147
• MDR Text Key: 186711053
• Report Number: 2134265-2020-04590
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K964284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2007
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0006864237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR