MAUDE Adverse Event Report: WILLIAM COOK EUROPE NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-JUG-CELECT

Device Problems Fracture (1260); Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Blood Loss (2597); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "(pt) received a cook gunther tulip filter on (b)(6) 2013".Patient outcome: it is alleged that (pt) was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient is alleging vena cava and organ (erosion of the ivc filter cause duodenal perforation) perforation, fracture, migration, and bleeding.Patient also alleges "severe abdominal pain; difficulty eating; unable to lift more than 8lbs; inability/difficulty to sleep at night; anxiety over the whole experience with the ivc filter and complex retrieval surgery and poor memory.Additionally, reconstruction of inferior vena cava; suture of perforation of duodenum; need for complex retrieval surgery and the pain and suffering associated with such complex retrieval surgery." 11feb2013, implant report: "at this time, ultrasound was used to identify the right internal jugular vein.The wire and dilator were then removed and the filter was then inserted and under fluoroscopic guidance, it was placed into appropriate position and then delivered appropriately.Once that was completed, the flush venogram was then performed that showed the filter in good position below the renal veins and above the dvt." (b)(6) 2013, product id: this document confirms that a celect filter was implanted, not tulip as previously reported.(b)(6) 2019, report from venogram: "the filter was still patent and flow was quite brisk coming from the right common iliac vein." (b)(6) 2018, report from ct: "infrarenal ivc filter seen eroding into the adjacent third portion of the duodenum anteriorly and distal portion of the abdominal aorta medially.No evidence of drainable fluid collection in the abdomen or pelvis.There is minimal stranding and inflammatory changes around the third portion of duodenum without evidence of drainable abdominal fluid collection." (b)(6) 2018, retrieval report (successful): "erosion of inferior vena cava filter causing duodenal perforation.We then proceeded to obtain distal control of the ivc.The duodenum was completely kocherized and was noted to be a leg of the ivc filter going through the third portion of the duodenum causing a perforation.The perforation appear contain as there was no bile or succus in the area.We then cut the leg of the filter with a wire cutter and we removed the piece of the filter inside the duodenum and passed it off the field as a specimen.The hole in the duodenum was small.It was repaired with interrupted 3-0 silk sutures in a lembert fashion.We then proceeded to obtain distal control of the ivc.We dissected the inferior vena cava distal to the ivc filter, which can be palpated.We then clamped the inferior vena cava proximally and distally and occluded all branches that were previously encircled with vessel loops.The inferior vena cava was entered using an 11 blade.The venotomy was lengthened using potts scissors.There was noted to be bleeding from the venotomy indicating there were still branches of the inferior vena cava and that were not controlled.We then clamped the venotomy using a satinsky clamp.We dissected the inferior vena cava posteriorly and encountered large lumbar veins.The lumbar veins were controlled using silastic vessel loops and then occluded.Satinsky clamp was released from the venotomy and there was noted to be no further bleeding.The venotomy was then lengthened further distally and proximally until the entire inferior vena cava filter was exposed.There was noted to be multiple legs of the filter eroding through the inferior vena cava.The inferior vena cava however was scarred into the wall and could not be removed in its entirety.Therefore, the legs of the filter were cut with a wire cutter.The inferior vena cava filter was then explanted and passed off the field as a specimen.Through another cut, remaining legs were identified and removed as well passed off the field as specimens.Now, we palpated the inferior vena cava was noted to be no foreign body left inside the vein.We then proceeded to reconstruct the inferior vena cava.The patient was successfully extubated in the operating room and was transferred to the surgical intensive care unit in stable condition.".

Event Description

No additional information has been provided at this time.

Manufacturer Narrative

Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Vena cava wall penetration/perforation has been reported and 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.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 patient¿s individual risk/benefit profile (e.G., a patient¿s 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 günther 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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.Unknown if the reported bleeding, anxiety, difficulty eating, inability to lift more than 8 lbs, inability/difficulty sleeping, poor memory, severe abdominal pain, suffering are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No relevant notes on work order.One other complaint on lot.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.The following allegations have been investigated: fracture, vena cava and organ perforation, migration, complex(difficult) retrieval, bleeding, anxiety, difficulty eating, inability to lift more than 8 lbs, inability/difficulty sleeping, poor memory, severe abdominal pain, and suffering.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8548597
• MDR Text Key: 143036873
• Report Number: 3002808486-2019-00458
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

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
• Device Expiration Date: 09/10/2015
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E2975802
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2019
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 06/07/2019; 08/13/2019
• Supplement Dates FDA Received: 06/28/2019; 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 72