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

Model Number 43175

Device Problem Break (1069)

Patient Problem Perforation (2001)

Event Date 03/13/2018

Event Type  Injury  

Event Description

It was reported that there was a perforation.The patient had a greenfield filter implanted on (b)(6) 2010 following discovery of acute right lower extremity deep vein thrombosis (dvt) in the setting of trauma (car accident).The patient's recovery from the car accident was complicated by osteomyelitis of the right leg following several surgeries.The patient was treated with anticoagulation for 6 months after filter implantation.She has had no additional dvt events.In (b)(6) 2017, the patient reported abdominal, leg and back pain with nausea.On (b)(6) 2018 the patient had a ct scan of their abdomen.The results showed that an ivc filter is in place, with the superior aspect of the filter at the level of the lower aspect of the l2 vertebral body.There were 6 struts of the ivc filter, located at the odd numbered positions of the clock face.The strut at the 1 o'clock position protruded 4 mm beyond the ivc.The strut at the 3 o'clock position protruded 7.5 mm beyond the ivc just behind the aorta.The strut at the 5 o'clock position protruded 11 mm beyond the wall of the ivc and protruded into the inferior aspect of the l3 vertebral body.The strut at the 7 o'clock position protruded 9 mm beyond the wall of the ivc.The strut at the 9 o'clock position protruded 4 mm beyond the wall of the ivc.The strut at the 11 o'clock position protruded 4 mm beyond the wall of the ivc.The top of the ivc filter was adjacent to the anterior wall of the ivc, and the filter itself was tilted anteriorly approximately 11 degrees.It was also noted there was a fractured hook that was embedded into the l3 vertebral body.On (b)(6) 2018, the patient reported symptoms of mid abdominal pain and mid to low back pain.She also reported severe nausea when bending forward.The leg and back pain was rated 8/10 with associated numbness, heaviness and tingling.The patient was referred to another facility to have their filter removed.On (b)(6) 2018, the patient had their filter snared out and removed.Post procedure a pseudoaneurysm was found in the leg of the patient where the physician had gained access.The physician inflated a non-bsc balloon at the site of the pseudoaneurysm for approximately 3 minutes.The patient recovered well from all of these events.

• 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; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9088504
• MDR Text Key: 159357358
• Report Number: 2134265-2019-11057
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0013172492
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR