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

Device Problems Break (1069); Migration (4003)

Patient Problem Perforation (2001)

Event Date 08/23/2009

Event Type  Injury  

Event Description

It was reported a filter migration and perforation occurred.In approximately 2002, the patient was implanted with a greenfield vena cava filter (gvcf).On (b)(6) 2009, the patient underwent a computed tomography (ct) scan of his abdomen and pelvis which revealed the filter was "malpositioned".The filter struts had perforated through the wall of the patient's vena cava along the psoas muscle and is tilted posteriorly.On (b)(6) 2009, the patient underwent an implantation of a non-bsc inferior vena cava filter to protect from traveling clots.On (b)(6) 2016, the patient underwent another ct scan of his abdomen and pelvis.The ct scan revealed that the greenfield filter tip appeared to project outside the vena cava and touched the right aspect of patient's l5 vertebral body and a few of the struts distally project outside the lumen of the vein.On (b)(6) 2016, the patient underwent open laparotomy surgery.The physician noted two of the gvcf legs had perforated the patient's iliac artery, two had perforated the psoas muscle, and one was free-floating in the retroperitoneum.The physician also noted that the sixth leg was unable to be located.The body of the filter was left inside of patient's body due to the high risks associated with removal.

Event Description

It was reported a filter migration and perforation occurred.In approximately 2002, the patient was implanted with a greenfield vena cava filter (gvcf).On (b)(6) 2009, the patient underwent a computed tomography (ct) scan of his abdomen and pelvis which revealed the filter was "malpositioned".The filter struts had perforated through the wall of the patient's vena cava along the psoas muscle and is tilted posteriorly.On (b)(6) 2009, the patient underwent an implantation of a non-bsc inferior vena cava filter to protect from traveling clots.On (b)(6) 2016, the patient underwent another ct scan of his abdomen and pelvis.The ct scan revealed that the greenfield filter tip appeared to project outside the vena cava and touched the right aspect of patient's l5 vertebral body and a few of the struts distally project outside the lumen of the vein.On (b)(6) 2016, the patient underwent open laparotomy surgery.The physician noted two of the gvcf legs had perforated the patient's iliac artery, two had perforated the psoas muscle, and one was free-floating in the retroperitoneum.The physician also noted that the sixth leg was unable to be located.The body of the filter was left inside of patient's body due to the high risks associated with removal.It was further reported that on (b)(6) 2016, the patient came to the hospital for evaluation of right groin pain that had been present for the past week.He staled that the pain increased with ambulation as well as with flexion of the leg.He stated that any time he moved his leg the pain in his groin is aggravated.He has extensive dilationed veins in his lower extremities.He was on coumadin therapy.On (b)(6) 2019, it was noted that the tip of the filter migrated through the iliac vein into the retroperitoneum medial to the psoas.The physician looped the external iliac artery with a vessel loop to pull it medially and then dissected the five prongs that were outside of the iliac vein, and cut the prongs with the wire cutter.They were able to take the two out of the external iliac artery followed by taking the two that were into the psoas and then the one that was free-floating in the retroperitoneum.

• 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: 8168754
• MDR Text Key: 130468727
• Report Number: 2134265-2018-64019
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR