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

Model Number 43175

Device Problem Positioning Failure (1158)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Date 06/21/2017

Event Type  Injury  

Event Description

It was reported the device did not fully deploy and later a perforation occurred.On (b)(6) 2004 the patient under implantation of a greenfield vena cava filter.This filter did not fully deploy, so a second filter was surgically implanted.On (b)(6) 2017 the patient received a ct scan.These images showed that: the tip of the superior filter implanted in the patient had tilted into their right renal vein; that many of the filter struts had perforated beyond the inferior vena cava wall, one leg abuts the aortic wall and that two legs abut the wall of the duodenum.On (b)(6) 2017, the patient received another ct scan which revealed that the superior filter had titled and was angulated approximately 30-40 degrees, one of the struts of the superior filter abuts the aortic intima, another strut abuts the posterior duodenum, another superior filter abuts the anterior aspect of the l3 vertebral body, with subjacent bony remodeling; the inferior filter was within 10 degrees of parallel to the superior filter and the struts of both filters extended beyond the ivc wall.On (b)(6) 2017, the patient had surgery to remove both filters as they were symptomatic with pain.The surgeon noted the more superior filter had significant tilt with the hook near the right renal vein embedded in a fibrin cap and that several struts extended beyond the ivc wall.

• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8634034
• MDR Text Key: 145860322
• Report Number: 2134265-2019-05446
• 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: Other
• Type of Report: Initial
• Report Date: 05/22/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention