MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number N/A

Device Problems Filter (1236); Fracture (1260); Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135); Sleep Dysfunction (2517)

Event Date 08/09/2013

Event Type  Injury  

Manufacturer Narrative

Brand name unknown as catalog number is unknown.Lot, catalog #, expiration - unknown as not provided by reporter.Mfr date: unknown as lot is unknown.Patient (b)(4).Investigation evaluation: still under investigation.

Event Description

The allegations of the claim is: this is a (b)(6) female patient with recurrent acute right popliteal dvt and recent shortness of breath, suspicious for pulmonary embolism.The patient had been off and on anticoagulation without significant protection from pulmonary embolism and dvt.Ivc filter placement was requested.Tulip filter placement was on (b)(6) 2004.The patient was accessed through the right common femoral vein using the seldinger technique.Hand injection digital subtraction venogram is performed from each vein (two right and one left renal veins).The delivery device was then inserted and the ivc filter placed below the inferior right renal vein, final venacavogram performed through the sheath, all is removed, and hemostasis obtained with direct manual compression.The patient tolerated the procedure well with no immediate complications.The findings with limited ultrasound of the right leg showed no evidence of thrombus in the right common femoral vein.The inferior venacavogram showed normal diameter of the interior vena cava thrombus.There was a small amount of reflux into left and right renal veins in the expected position, as well as an additional small amount of reflux into a vein on the right below the main right renal vein.The renal veins were then selected and there appeared to be an accessory right renal vein below the main right renal vein.The tulip filter was placed successfully in the ivc.On (b)(6) 2013, the patient with right-sided abdominal pain underwent a ct scan of the abdomen and pelvis without intravenous contrast.This was compared to a ct scan of abdomen and pelvis dated (b)(6) 2013.The august ct revealed that the ivc filter is present within the infrarenal ivc.The 3-d of the legs protrude through the wall of the ivc.The posterior leg protrudes approximately 17mm and appears to touch the anterior margin of the osteophyte arising from the right superolateral margin aspect of the l3 vertebral body.There are no associated inflammatory changes.

Event Description

The allegations of the claim is.This is a (b)(6) female patient with recurrent acute right popliteal dvt and recent shortness of breath, suspicious for pulmonary embolism.The patient had been off and on anticoagulation without significant protection from pulmonary embolism and dvt.Ivc filter placement was requested.Tulip filter placement was on (b)(6) 2004.The patient was accessed through the right common femoral vein using the seldinger technique.Hand injection digital subtraction venogram is performed from each vein (two right and one left renal veins).The delivery device was then inserted and the ivc filter placed below the inferior right renal vein, final venacavogram performed through the sheath, all is removed, and hemostasis obtained with direct manual compression.The patient tolerated the procedure well with no immediate complications.The findings with limited ultrasound of the right leg showed no evidence of thrombus in the right common femoral vein.The inferior venacavogram showed normal diameter of the interior vena cava without thrombus.There was a small amount of reflux into left and right renal veins in the expected position, as well as an additional small amount of reflux into a vein on the right below the main right renal vein.The renal veins were then selected and there appeared to be an accessory right renal vein below the main right renal vein.The tulip filter was placed successfully in the ivc.On (b)(6) 2013 the patient with right-sided abdominal pain underwent a ct scan of the abdomen and pelvis without intravenous contrast.This was compared to a ct scan of abdomen and pelvis dated (b)(6) 2013.The august ct revealed that the ivc filter is present within the infrarenal ivc.3-d of the legs protrude through the wall of the ivc.The posterior leg protrudes approximately 17 mm and appears to touch the anterior margin of the osteophyte arising from the right superiolateral margin aspect of the l3 vertebral body.There are no associated inflammatory changes.No additional information has been provided to assist in this investigation.Investigation - evaluation: evaluation was based on event description at this time, since no device, medical records or imaging have been returned.The device remains implanted - if it has been removed or attempted removal the information has not been provided.It is unknown if the patient has undergone any additional procedures due to the allegations as no additional information has been provided.The allegations of the potential claim allege that the tulip filter posterior leg protrudes the vessel wall and causing right-sided abdominal pain.Filter perforation of the vena cava wall is a well known risk in the literature.Several case reports published in articles, describe filter perforation of the vena cava wall.Following articles seem relevant.[1] oh jc, trerotola so, dagli m, et al removal of retnevable inferior vena cava filters with computed tomography findings indicating tenting or penetration of the inferior vena cava wall j vasc interv radiol 2011,22 70-4.12] t d townsend, s rathbun, a gautam, and t whitsett, images in vascular medicine persistent abdominal pain from a perforated inferior vena cava filter 86, vasc med., 12 (2007) 33-34.[3] alicia laborda, dvm, phd et al laparoscopic demonstration of vena cava wall penetration by inferior vena cava filters in an ovine model.[4] rafael d malgor et al a systematic review of symptomatic duodenal perforation by inferior vena cava filters, j vasc surg 2011.A reference is made to the instructions for use.In potential adverse events are mentioned.Damage to the vena cava.Pulmonary embolism pulmonary embolism filter embolization vena cava perforation vena cava occlusion or thrombosis hemorrhage extravasation of contrast material at time of vena cavagram hematoma at vascular access site infection at vascular access site thrombosis or stenosis at implant site death as no device, imaging studies, or hospital/medical records have been returned, the investigation is limited to the allegations in the lawsuit.Consequently, based on the very limited information it is difficult to comment on the alleged filter perforation and abdominal pain we are unable to determine the root cause based on the limited information provided.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the conclusion of quality engineering risk assessment (qera), further risk reduction will not be conducted at this time.The medical benefit of prevention of recurrent pulmonary embolisms obtained by placing an ivc filter outweighs the residual risk of ivc perforation.

Manufacturer Narrative

(b)(4).Corrected data based on new information received: adverse event or problem: adverse event and product problem to product problem, type of reportable event: serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information was received on 12/11/2015 as follows: the plaintiff allegedly received the filter implant on (b)(6) 2004 due to recurrent acute right popliteal dvt with possible pe.Ct report from (b)(6) 2013 alleges ¿the limbs of the retrievable ivc filter extend through the wall of the ivc.¿ per additional information submitted by the plaintiff, no filter retrieval attempt had occurred as of (b)(6) 2015.The plaintiff alleges tilt, vena cava perforation, pain, insomnia, and anxiety.

Manufacturer Narrative

Additional details: date of report.Correction(s) adverse event or product problem: from product problem to adverse event and product problem.(b)(4).Type of reportable event: from malfunction to serious injury.Evaluation: it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.It is unknown if the reported pain, insomnia and anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.There is 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.

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

Patient alleges fracture (fractured leg in l2/l3 disc), organ perforation, embedment.Patient further alleges having a low grade temperature, recurrent major depressive disorder, panic attacks, ptsd.

Manufacturer Narrative

Investigation - evaluation: investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'tulip, fracture, tilt, vena cava + organ perforation, diff to retrieve (embedded), temp, pain, insomnia, anxiety, ptsd'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.A filter that is embedded in the wall of the ivc may be difficult to retrieve.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported pain/discomfort is directly related to the filter.Unknown if the reported temp, insomnia, anxiety, ptsd is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Catalog and lot# are unknown, but the tulip filter 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.

Event Description

No additional information provided at this time.

• Brand Name: UNKNOWN
• 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: 3952070
• MDR Text Key: 19395310
• Report Number: 1820334-2014-00302
• 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
• Source Type: Other,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/18/2014,12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2013
• Event Location: Hospital
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 54 YR
• Patient Weight: 93