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

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 10/24/2017

Event Type  Injury  

Event Description

A greenfield filter was implanted on (b)(6) 2004.On (b)(6) 2017 the patient had a ct scan of their abdomen.The imaging showed that an azygous vein was patent and the ivc fills above the occluded filter via the azygous system.In addition, 2 tines of the filter were fractured.On (b)(6) 2019 the patient had a ct scan of their abdomen and imaging showed that the top of the filter is seen at the suprarenal ivc with the filter coursing across the bilateral renal veins.The spires extend beyond the lumen of the ivc which is small proximal to the filter.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10376069
• MDR Text Key: 201940002
• Report Number: 2134265-2020-10659
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR