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

Catalog Number IGTCFS-65-JUG

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2020-00094.Occupation - non-healthcare professional.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch.(b)(4).Report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in this initial medwatch report.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava perforation/embedment, tilt.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.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.(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 become available.

Event Description

Patient allegedly received an implant on (b)(6) 2010 via the right internal jugular vein due to deep vein thrombosis (dvt).Patient is alleging tilt, vena cava perforation, and embedment.Report from ct: "there has been improvement in the size of the previously described inferior vena cava thrombus which is markedly reduced in size, extending over distance of 5.3cm below the level o the right renal vein.Of note, the inferior vena cava filter is above the level of the right renal vein.A circumaortic left renal vein is again noted which is relatively decreased in caliber compared to the right side.Extensive left perinephric stranding is again noted with tiny collateral vessels formation, stable.A left renal vein thrombosis could account for these findings." report from ct: "there is an a filter within the suprarenal inferior vena cava.Although evaluation for thrombi is limited secondary to timing of the contrast bolus, no definite large thrombus is visualized within the inferior vena cava, common iliac, internal iliac, or common femoral veins.Beam hardening artifact produced from the ivc filter also limits evaluation for small thrombi adjacent to the ivc filter itself.The abdominal aorta is grossly unremarkable without evidence for aneurysm." report from ct 2: "filter position: the filter is in the ivc superior to the level of the renal veins.Filter migration: none.Filter fracture: none.Ivc stenosis: none.Filter tilt: yes, see impressions.Filter penetration: yes, see impressions.Impressions: the filter is in the ivc superior to the level of the renal veins.This may have been inserted more superior than normal or may have migrated to this position.The filter is tiled posteriorly and to the left with its cone lying on the wall of the ivc possibly embedded within it.The legs of the filter have penetrated through the wall of the ivc into the pericaval/mesenteric fat.".

• Brand Name: GUNTHER TULIP JUGULAR 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: 9788073
• MDR Text Key: 195273565
• Report Number: 1820334-2020-00544
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2554202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2010
• 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: 104