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

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Perforation (2001); Thrombosis (2100)

Event Date 01/03/2019

Event Type  Injury  

Event Description

On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there was a strut that was misaligned and found on ct to be perforating the duodenum itself.The physician performed multiple attempts at snaring the filter tip, but could not engage the tip of the filter with the snare as it appeared to be covered with intimal hyperplastic tissue.Another sheath was attempted and the physician could not advance the inner sheath over the filter so this was placed just above the filter as the outer 16- french sheath was used to entrap the filter, this was successful.It was noted during removal that the laterally oriented strut appeared to be consistent with the strut that was responsible for the caval and duodenal perforation.It easily slid back into the lumen of the vena cava and into the sheath without much difficulty.It was noted that the entire sheath and filter were removed as a unit.On (b)(6) 2019 ct scan showed fat stranding in the retroperitoneum/pericaval region likely related to recent ivc filter and strut removal perforating the duodenum.Small filling defect noted in the ivc at chest below the level of the renal veins, suggestive of a nonocclusive thrombus.

Event Description

On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen/pelvis-infrarenal revealed there was a strut that was misaligned and found on ct to be perforating the duodenum itself.The physician performed multiple attempts at snaring the filter tip, but could not engage the tip of the filter with the snare as it appeared to be covered with intimal hyperplastic tissue.Another sheath was attempted and the physician could not advance the inner sheath over the filter so this was placed just above the filter as the outer 16- french sheath was used to entrap the filter, this was successful.It was noted during removal that the laterally oriented strut appeared to be consistent with the strut that was responsible for the caval and duodenal perforation.It easily slid back into the lumen of the vena cava and into the sheath without much difficulty.It was noted that the entire sheath and filter were removed as a unit.On (b)(6) 2019 ct scan showed fat stranding in the retroperitoneum/pericaval region likely related to recent ivc filter and strut removal perforating the duodenum.Small filling defect noted in the ivc at chest below the level of the renal veins, suggestive of a nonocclusive thrombus.It was further reported that on (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.

• 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: 9945694
• MDR Text Key: 187730786
• Report Number: 2134265-2020-04823
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR