MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number UNK141

Device Problem Occlusion Within Device (1423)

Patient Problems Fever (1858); Pain (1994); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the patient experienced complications and the filter was occluded.In (b)(6) 2005, the patient was admitted to the hospital with a diagnosis of right lower extremity deep vein thrombosis (dvt).Two days later a clot extraction was performed on her right leg and a greenfield filter was implanted in her left inferior vena cava.The patient's hospital course was complicated by fever of unknown etiology.The patient remained at the hospital for a total of 10 days before being transferred to another facility where she underwent an angiojet thrombectomy procedure.The patient was discharged from that facility 11 days later.In (b)(6) 2005, approximately 2 weeks post discharge, the patient was taken to the emergency room complaining of left thigh and lower abdomen pain.She was admitted to the hospital the next day due to extensive clots in the right lower extremity and acute dvt of the left lower extremity.In (b)(6) 2010, the patient was seen for possible occlusion of the greenfield filter.The patient returned approximately 2 weeks later for the same reason.In (b)(6) 2015 a ct scan revealed the greenfield filter was occluded.The patient must continue to be on blood thinners the rest of her life.

• Brand Name: TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5702766
• MDR Text Key: 46673355
• Report Number: 2134265-2016-04733
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• 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