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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Perforation (2001); Hematuria (2558)

Event Date 02/27/1998

Event Type  Injury  

Event Description

On (b)(6) 1997 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 1998 medical record history revealed a deep vein thrombosis (dvt) and pulmonary embolism occurred with the filter in place and the onset of hematuria.On (b)(6) 2018 the filter was not removed as given the age and appearance of the filter, there was a high risk for vascular injury and it was unlikely to be causing the symptoms.On (b)(6) 2018 a computed tomography (ct) scan of the abdomen revealed a perforation with the superior tip of the filter being approximately 1.6cm below the insertion of the left renal vein.On (b)(6) 2018 the patient had a recurrent pulmonary embolism and an ultrasound of the lower extremities/bilateral veins that revealed thrombus in the left common femoral, superficial femoral, and popliteal veins.Thrombus was within the right common femoral vein.The presence of collateral vessels and the history of prior dvt suggests that this may be chronic.On (b)(6) 2018 a computed tomography (ct) scan revealed a mesenteric perforation.The top of the filter was 7mm below the level of the left renal vein.There was no significant tilt of the filter axis.The struts of the filter appeared to extend outside the inferior vena cava walls by as much as 4mm.An anterior strut appeared to contact the adjacent small bowel.On 16 february 1999 an ultrasound of the right side noted a dvt.

Event Description

On (b)(6) 1997 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 1998 medical record history revealed a deep vein thrombosis (dvt) and pulmonary embolism occurred with the filter in place and the onset of hematuria.On (b)(6) 2018 the filter was not removed as given the age and appearance of the filter, there was a high risk for vascular injury and it was unlikely to be causing the symptoms.On (b)(6) 2018 a computed tomography (ct) scan of the abdomen revealed a perforation with the superior tip of the filter being approximately 1.6cm below the insertion of the left renal vein.On (b)(6) 2018 the patient had a recurrent pulmonary embolism and an ultrasound of the lower extremities/bilateral veins that revealed thrombus in the left common femoral, superficial femoral, and popliteal veins.Thrombus was within the right common femoral vein.The presence of collateral vessels and the history of prior dvt suggests that this may be chronic.On (b)(6) 2018 a computed tomography (ct) scan revealed a mesenteric perforation.The top of the filter was 7mm below the level of the left renal vein.There was no significant tilt of the filter axis.The struts of the filter appeared to extend outside the inferior vena cava walls by as much as 4mm.An anterior strut appeared to contact the adjacent small bowel.On (b)(6) 1999 an ultrasound of the right side noted a dvt.

• 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: 9940070
• MDR Text Key: 187731155
• Report Number: 2134265-2020-04747
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR