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

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Perforation (2001); Thrombosis (2100)

Event Date 07/23/2019

Event Type  Injury  

Event Description

It was reported that a perforation and thrombosis occurred.In (b)(6) 2012, a greenfield vena cava filter was positioned at the appropriate level and deployed with in the vena cava.The patient tolerated the procedure well and left the procedure room in stable condition.In (b)(6) 2019, a non-contrast computed tomography (ct) of the abdomen revealed a filter within the inferior vena cava (ivc) with the tip located at the lower most margin of the right renal vein.The filter was intact and appeared centrally positioned within the ivc without evidence of tilt.There were six filter struts which protrude approximately 2.2 mm outside the lumen of the ivc.There is at least one anterior strut abuts a short segment of small bowel and another that abuts the wall of the aorta.Two other struts posteriorly about the anterior margin of the l4 vertebral body.The caliber of the inferior vena cava is small, suggesting the inferior vena cava is thrombosed.

Manufacturer Narrative

A2 date of birth: corrected from (b)(6) 1947 to (b)(6) 1945.A3 sex: corrected from female to male.B3 date of event: corrected from (b)(6) 2019 to (b)(6) 2019 b5 describe event or problem: corrected b7 other relevant history: updated d6 implant date: corrected from (b)(6) 2012 to (b)(6) 2001 h6 patient codes: corrected to remove thrombosis h6 device codes: corrected to remove 'adverse event without identified device or use problem' and add 'positioning problem' and 'material integrity problem'.

Event Description

It was reported that positioning issues and perforation occurred.In (b)(6) 2001, a greenfield vena cava filter was implanted in the distal inferior vena cava (ivc) below the right renal vein.The patient was sent to the recovery room and then to the floor in stable condition.In (b)(6) 2019, computed tomography of the abdomen revealed the top of filter was tilted posteriorly with the tip against the posterior wall of ivc.The top of the filter was approximately 5mm below right renal vein which is lower than left renal vein, no evidence filter migration.Two (2) left sided struts appear to perforate beyond ivc wall without adjacent organ or adjacent vessel involvement by approximately 1mm each with fat plane visualized between ivc wall and distal tip of strut.All struts had a slightly curved appearance.

• 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: 10364730
• MDR Text Key: 201732409
• Report Number: 2134265-2020-10472
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 08/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR