MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-FEM

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Occlusion (1984); Thrombosis (2100); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook (b)(4) under manufacturer report reference# 3002808486-2020-00645.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # reporter occupation: non-healthcare professional.Investigation: the following allegations have been investigated: vena cava perforation, aorta occlusion dvt/clots, tilt, stomach pains, cramps, swollen legs, weak muscles, depression.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported aorta occlusion, stomach pains, cramps, swollen legs, weak muscles, depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

Patient allegedly received an implant on (b)(6) 2011 via the right common femoral vein due to recurrent pulmonary embolism (pe) and anticardiolipin.The patient alleges tilt, penetration of the filter legs through the ivc caval wall, and 50% occlusion of abdominal aorta lumen secondary to the thrombosis.The patient further alleges sharp stomach pains, severe cramps, blood clots, swollen legs, weak muscles, deep vein thrombosis, and depression.23jan2015, per a report from computed tomography; ¿conclusion: retrievable infrarenal ivc filter.The tip of the ivc filter is tilted against the right posterior lateral wall, the filter tip has an associated area of luminal deformity likely representing an area of scar/fibrous web.Small focus of nonocclusive thrombus measuring up to 1.2 cm in length extending from the tip of the ivc filter, the remaining portions of the ivc including within the filter are patent.¿ 27mar2015, per a report from computed tomography; ¿ ¿an inferior vena cava filter is present in stable position when several of the struts penetrating the caval wall".Conclusion: 1.Focal nonocclusive thrombus in the infrarenal abdominal aorta at the level of the inferior mesenteric artery.The thrombus appears stable in size measuring approximately 4.5 cm in length with approximately 50% luminal narrowing at the level of the distal portion of the thrombus.No new focal areas of thrombus are identified.The celiac and sma are patent.Patent single renal arteries bilaterally.2.Inferior vena cava filter with a stable nonocclusive thrombus extending from the vena cava filter tip into the inferior vena cava.The filter body appears free of thrombus, the inferior vena cava is patent.¿.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10367793
• MDR Text Key: 203502220
• Report Number: 1820334-2020-01434
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2526003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 78