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

Catalog Number IGTCFS-65-FEM-CELECT-PERM

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Perforation of Vessels (2135); Great Vessel Perforation (2152); Injury (2348); Disability (2371)

Event Date 03/02/2012

Event Type  Injury  

Event Description

Description of event according to complainants attorney: it is alleged that "on or about (b)(6) 2008, the patient was involved in a motorvehicle accident and suffered from a patella and tibial fracture in his right leg and presented to (b)(6) hospital for care.During this hospital stay, patient was recommended for placement for a cook celect ivc filter in an effort to avoid blood clots in his lower extremities.On (b)(6) 2008, he underwent a procedure wherein a cook celect ivc filter was implanted within his body as a prophylactic measure to protect him from pulmonary embolisms.There were no complications.Patient was examined for believed venous insufficiency which required a ct examination.On (b)(6) 2012, patient presented to (b)(6) hospital for the ct examination.During the (b)(6) 2012 ct examination, it was discovered that all of the barb tips and stabilizing points of the ivc had protruded outside of the vena cava and one barb extending directly into the abdominal aorta and a second barb abutting the duodenum.On (b)(6) 2012, the patient presented to the (b)(6) hospital for removal of the inferior vena cava filter and repair to the duodenum and vena cava.Patient was forced to undergo exploratory laparotomy with removal of the ivc filter, placement of the catheter into the inferior vena cava via the internal jugular, and direct repair of the ivc after filter removal.During this procedure, the hook of the ivc could not be engaged and the procedure was converted to an open procedure.Physicians were only able to remove the ivc filter along with fractured struts.However, on (b)(4) 2012, patient developed a large right retroperitoneal hematoma.Patient was finally discharged on (b)(6) 2012".It is alleged that the "patient suffered permanent and continuous injuries, pain and suffering, disability and impairment.Patient has suffered emotional trauma, harm and injuries that will continue into the future.".

Manufacturer Narrative

(b)(4).Lot#: e2160493.Investigation evaluation: no device, imaging studies or hospital or medical records have been available.Consequently, based on very limited information it is not possible to comment on the alleged filter legs perforating the ivc approximately 3.5 years after placement and/or the permanent and continuous injuries, pain and suffering, disability and impairment, which patient suffered as well as emotional trauma, harm, and injuries that will continue into the future.According to device history record 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.The exact root cause for the alleged filter leg perforation(s) cannot be determined based on the limited information provided.Cook medical will continue to monitor for similar reports.

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on (b)(6) 2015 as follows: plaintiff allegedly received an implant on (b)(6) 2008 via the right femoral vein due to mva high risk for dvt with successful retrieval on (b)(6) 2012.Plaintiff is alleging vena cava perforation, bleeding, organ perforation, embedded, disability, pain, abdominal problems including hernia developed as a result of the surgery.

Manufacturer Narrative

(b)(4).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 'fracture, ivc and organ perforation, diff retrieval, bleeding, embedded, disability, pain, hernia'.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 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 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 filter fragment embolized into the heart or lung may be safely retrieved.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.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 4558906
• MDR Text Key: 5551600
• Report Number: 3002808486-2015-00009
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• 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
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2010
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/02/2015
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR
• Patient Weight: 118