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

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/29/2020

Event Type  Injury  

Event Description

It was reported that the filter was occluded, and required removal.On (b)(6), 2007, the patient was implanted with a greenfield filter.The patient had a history of deep venous thrombosis (dvt).On (b)(6), 2020, the patient received an abdominal ct scan after experiencing lower extremity swelling.The inferior vena cava (ivc) filter was observed in place with associated severe stenosis of the intrarenal ivc.There was a demonstrated iliocaval obstruction to the filter.On (b)(6), 2020, the patient underwent procedural removal of the greenfield filter via jugular approach.The filter was fully retracted within the sheath, and subsequently removed.The procedure was successfully completed without reported complications.No further patient complications were reported.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15479613
• MDR Text Key: 300563450
• Report Number: 2124215-2022-35691
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male