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

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/29/2019

Event Type  Injury  

Event Description

A greenfield filter was implanted on (b)(6) 2010.On (b)(6) 2019 the patient had a ct scan of their abdomen.The imaging showed that several of the struts were perforating the ivc.The stricts at the 12 o'clock position and 2 o'clock position appeared to penetrate into the duodenum.On (b)(6) 2019 a ct scan of the abdomen showed similar results as well as one strut that was adjacent to the abdominal aorta.On (b)(6) 2019 the patient had their greenfield filter removed.The duodenum was repaired during the surgery.Additionally one of the struts fractured and could not be located or removed from the patient.

Event Description

A greenfield filter was implanted on (b)(6) 2010.On (b)(6) 2019 the patient had a ct scan of their abdomen.The imaging showed that several of the struts were perforating the ivc.The strict's at the 12 oclock position and 2oclock position appeared to penetrate into the duodenum.On (b)(6) 2019 a ct scan of the abdomen showed similar results as well as one strut that was adjacent to the abdominal aorta.On 06 december 2019 the patient had their greenfield filter removed.The duodenum was repaired during the surgery.Additionally one of the struts fractured and could not be located or removed from the patient.It was further reported that the patients date of birth was (b)(6) 1983.

• 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: 10376673
• MDR Text Key: 202004958
• Report Number: 2134265-2020-10682
• 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: 12/15/2020

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: 12/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR