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

Model Number 43175

Device Problems Break (1069); Migration (4003)

Patient Problems Pain (1994); Perforation (2001)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated as date is unknown.

Event Description

It was reported a perforation occurred and the filter fractured and migrated.On (b)(6) 2002, the patient underwent placement of a greenfield filter.The filter was implanted in the inferior vena cava (ivc) via jugular approach.Over the course of several years, the patient had two pulmonary embolisms.In late 2014 the patient began having frequent chest pain, abdominal pain and shortness of breath.Physicians felt it was related to the patient's lupus.In mid 2015 the patient began having intense lower back, leg and pelvic pain.The source of the pain was unable to be determined.A few months later the patient experienced back and hip pain and then eventually cold sweats accompanied by chest pain.The patient presented to the emergency room and it was revealed that the filter had perforated the ivc.The patient was directed to their primary physician.The pain ultimately worsened and the patient was unable to be treated due to risk.In (b)(6) 2017, the patient returned to the implanting facility where the perforation was confirmed.The patient was transferred to a heart and vascular hospital.On (b)(6) 2017 surgery was performed to attempt device retrieval via both jugular and femoral approach.Surgery revealed perforation of the ivc and the filter had fractured.Pieces of the filter had migrated and lodged in the spine.Another surgery was performed the following day with abdominal incisions the pieces of filter were retrieved and the ivc was repaired.The patient remained in the hospital for an extended time.After discharge the patient was prescribed pain medication for back and nerve pain and spasms.

• 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 CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8839212
• MDR Text Key: 152616121
• Report Number: 2134265-2019-08934
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• 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: Other
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2005
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0004682576
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2002
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention