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

Catalog Number IGTCFS-65-JUG

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Pain (1994); Perforation of Vessels (2135); Stenosis (2263); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2020-00860.Additional information provided determined that this device was manufactured by cinc.With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report.Initial reporter occupation: non-healthcare professional.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 (vc) perforation, embedded, deep vein thrombosis (dvt), stenosis, difficult to remove, tilt, pain, physical limitations.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patients individual risk/benefit profile (e.G., a patients continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the g¿nther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare¿ vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for embedded a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.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 pain and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of (b)(4) devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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 report will be submitted should additional 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 device tilt, vena cava perforation, device is unable to be retrieved, stenosis, and embedment.Patient notes and further alleges experiencing "pain when i bend forward on right side below rib", post implant dvt, and physical limitations.Per a ct abdomen without contrast: "ivc filter is seen at the l 1-l2-l3 level.It looks to be located at the level of the lowest renal vein.There is no significant tilt of the filter.The apex of the filter touches the posterior wall of the ivc at the l2-l3 disc level.There is perforation of the ivc wall by the posterior, medial and lateral struts.The posterior strut extends into the retroperitoneal fat by 7 mm.The medial strut extends beyond the wall by 6 mm.The lateral strut extends beyond the wall by a 2 mm.No organ involvement is seen.No filter strut fracture or bending.There is significant narrowing of the inferior vena cava distal to the strut located along the length of about 4 cm.The ivc measures only about 3 mm in anterior posterior dimension.I'm uncertain whether this is physiologic or due to stenosis".

• 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: 12026955
• MDR Text Key: 265243056
• Report Number: 1820334-2021-01543
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Catalogue Number: IGTCFS-65-JUG
• Device Lot Number: 2515935
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2010
• 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: 72