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

Model Number 43335

Device Problems Break (1069); Migration or Expulsion of Device (1395); Malposition of Device (2616); Positioning Problem (3009); Migration (4003)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

The patient underwent a greenfield filter implantation on (b)(6) 2004.On (b)(6) 2016 the patient underwent computerized tomography (ct) scan of her abdomen and pelvis.Examination of the ct scan revealed the filter was tilted with the top of the filter against the left lateral wall of the inferior vena cava and one of the struts had fractured into two sections and migrated; 2/3's of which was embedded in the patient's right ventricle and the remaining 1/3 was embedded through the t11-t12 intervertebral disc and into the t12 vertebral body of the patient's spine.The remaining 5 struts had all perforated through the wall of the vena cava, with 2 of them extending into her descending duodenum.On (b)(6) 2016 the patient underwent a percutaneous surgical procedure to remove the filter.At which time the treating physician reported the filter was tilted, the apex of the filter was embedded into the inferior vena cava, two struts of the filter had perforated through the vena cava and into her duodenum and that there was "full-term migration and disintegration" of several struts, resulting in one of the struts becoming lodged in the right ventricle and another strut lodged posteriorly.On (b)(6) 2016 the patient underwent follow up ct scan that confirmed the fractured strut remained lodged within her heart, extending from the right inferior ventricular chamber towards her interventricular septum.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that during the exam on (b)(6) 2016 it was the tip of the filter, not "top" of the filter against the left lateral wall.The filter tip lied just below the level of the renal veins.The fracture was the left posterior strut.The length of the fragment in t11-t12 was 16mm.The fracture in the right ventricle was likely embedded in the myocardium.There was no evidence of perforation or pericardial effusion.A right posterior strut was immediately adjacent to and possibly embedded within the right psoas muscle and a left lateral strut was immediately adjacent to the aortic wall.There was no evidence of injury to either of those organs.

Event Description

The patient underwent a greenfield filter implantation on (b)(6) 2004.On (b)(6) 2016 the patient underwent computerized tomography (ct) scan of her abdomen and pelvis.Examination of the ct scan revealed the filter was tilted with the top of the filter against the left lateral wall of the inferior vena cava and one of the struts had fractured into two sections and migrated; 2/3's of which was embedded in the patient's right ventricle and the remaining 1/3 was embedded through the t11-t12 intervertebral disc and into the t12 vertebral body of the patient's spine.The remaining 5 struts had all perforated through the wall of the vena cava, with 2 of them extending into her descending duodenum.On (b)(6) 2016 the patient underwent a percutaneous surgical procedure to remove the filter.At which time the treating physician reported the filter was tilted, the apex of the filter was embedded into the inferior vena cava, two struts of the filter had perforated through the vena cava and into her duodenum and that there was "full-term migration and disintegration" of several struts, resulting in one of the struts becoming lodged in the right ventricle and another strut lodged posteriorly.On (b)(6) 2016 the patient underwent follow up ct scan that confirmed the fractured strut remained lodged within her heart, extending from the right inferior ventricular chamber towards her interventricular septum.It was further reported that during the exam on (b)(6) 2016 it was the tip of the filter, not "top" of the filter against the left lateral wall.The filter tip lied just below the level of the renal veins.The fracture was the left posterior strut.The length of the fragment in t11-t12 was 16mm.The fracture in the right ventricle was likely embedded in the myocardium.There was no evidence of perforation or pericardial effusion.A right posterior strut was immediately adjacent to and possibly embedded within the right psoas muscle and a left lateral strut was immediately adjacent to the aortic wall.There was no evidence of injury to either of those organs.It was further reported that the device was implanted on (b)(6) 2004.

• Brand Name: GREENFIELD
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7228128
• MDR Text Key: 98574571
• Report Number: 2134265-2018-00455
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K955396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR