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 Fracture (1260); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Heart Failure (2206); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.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 celect filter on (b)(6) 2009".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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation and device tilt.The investigation was reopened due to additional information provided.The following allegations have been investigated: fracture, migration, organ/vena cava perforation, "filter strut located in the right atrioventricular groove in the epicardial space," heart failure, loss of right kidney, "fragment on heart could move anytime," pain almost all [the] time, dark fluid around right kidney, loss of enjoyment of life, loss of most mobility, social dependency, dependency on medication and diet to live, shortness of breath, and limited physical activity/enjoyment of life/sleeping (pain).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.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 "filter strut located in the right atrioventricular groove in the epicardial space," heart failure, loss of right kidney, "fragment on heart could move anytime," pain almost all [the] time, dark fluid around right kidney, loss of enjoyment of life, loss of most mobility, social dependency, dependency on medication and diet to live, shortness of breath, and limited physical activity/enjoyment of life/sleeping (pain) are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No other complaints on lot(s).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 becomes 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 allegedly received an implant on (b)(6) 2009 via the right common femoral vein due to high risk for dvt (deep vein thrombosis) and possible pulmonary embolism.Patient is alleging migration, vena cava perforation, fracture, and filter strut located in the right atrioventricular groove in the epicardial space.The following information was also further alleged: "heart failure; loss of right kidney; fragment on heart could move anytime; pain almost all time; dark fluid around right kidney; loss of enjoyment of life; loss of most of my mobility; have to depend on my family and friends; and i have to depend on medication and diet to live." and limitations on "walking, almost all activities, shortness of breath, my housework, driving or riding long distance, enjoying life, sleeping (pain)." an unsuccessful percutaneous retrieval attempt also reportedly occurred on (b)(6) 2018.It was reported that the reason for the retrieval was "perforation of many filter struts and broken strut fragment." per a report from ct (computed tomography) dated (b)(6) 2018, "curvilinear high attenuation object extending from the right atrioventricular groove to the pericardium, favored to reflect an embolized inferior vena cava strut." per a retrieval report dated (b)(6) 2018, "the filter struts appear to be projecting outside the caval wall." "no significant thrombus identified within the inferior vena cava filter on initial contrast cavography.Successful retrieval of the right common femoral vein broken ivc filter strut with no complication.Complex retrieval of inferior vena cava filter (cook [celect] filter).Evidence of a broken 12th strut located in the right side of the heart.Since the exact location of the strut within the right heart is not known (although we know that it was in the at least a week ago based on ct venogram of 9/11/2018), a cardiac cta is recommended to further evaluate the location.No attempt at retrieving this strut was made.No evidence of contrast extravasation on post retrieval inferior venacavography" per a report from ct dated (b)(6) 2018, "18 mm metallic fragment in the right atrioventricular groove, in close approximation to the midportion of the right coronary artery without evidence of vascular injury.I suspect that most, if not all of it, lies in the epicardial space.No associated hematoma." per a report from xray dated (b)(6) 2018, "ivc filter is incompletely evaluated in this study." "linear radiopaque structure about 2.1 cm in length is present anterior to the right hip, and may represent a dislodged piece of the ivc filter.Further evaluation with ct or ultrasound may be useful to confirm." per a report from ct (computed tomography) dated (b)(6) 2018, "ivc filter with tip at the renal vein confluence and multiple strands extending the lumen, one of which extends into the duodenum.Additional broken strut fragment measuring 1.8 cm is located at the junction of the right external iliac and common femoral veins, although without associated thrombus or stenosis.The remainder of the venous system is unremarkable, with no evidence of thrombus, extrinsic compression, or stenosis." per a retrieval note dated (b)(6) 2018, "retrieval of filter strut from the right cfv followed by groin sheath venogram" "note is made of one of small struts from the filter to be located in the right side of heart.After further review of cta, the strut was there on that exam.".

• 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
• MDR Report Key: 8830009
• MDR Text Key: 152309736
• Report Number: 3002808486-2019-01082
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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: 10/15/2011
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2451926
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 68