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

Catalog Number IGTCFS-65-1-UNI-CELECT

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Renal Failure (2041); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect 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

It is alleged that [pt] received a cook celect filter on (b)(6) 2014.It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2014 via the internal jugular vein due to deep vein thrombosis.Patient alleges vena cava perforation, fractured.Patient further alleges 'ugly scars frompercutaneous removal attempts-itchy, red scars.Pain during exercise and or bending, twisting, stenuous activity, received contrast due for procedures more times than necessary which caused stress and further failure on my kidneys , weight gain since not able to exercise with pain or fear of strut becoming dislodged and migrating to my heart or bloodstream.Patient has another non-cook filter (bard denali) implanted on (b)(6) 2013.Attempted filter retrieval performed on (b)(6) 2014 and successful filter retrieval performed on (b)(6) 2017.Per ct, on (b)(6) 2017: " a suprarenal and infrarenal ivc filter present.An extraluminal limb is noted along the right lateral margin of the suprarenal filter with a fractured limb extending into the caudate lobe.Per ct, on (b)(6) 2017: " malpositioned superior ivc filter leg protruding into the caudate lobe is now separate/fractured from the filter itself and has migrated slightly, with the distal tip now projecting outside of the caudate lobe.

Manufacturer Narrative

Additional information: event, relevant tests/laboratory data, other relevant history, lot#.Exemption number: e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Device code: appropriate term/code not available (3191)- device perforation.Mfr site: name and address for importer site: (b)(4).This report includes information known at this time.A follow up report will be submitted should 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.

Manufacturer Narrative

Patient code(s): organ(s), perforation of (1987) was added in addition to the previously submitted patient codes.Device code(s): migration or expulsion of device (1395) was added in addition to the previously submitted patient codes.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated.Vena cava (vc) perforation, fracture, difficult retrieval, scars, pain, stress, disability, weight gain, further kidney failure, migration, loss of stamina, fear and limited activity.The reported allegations have been further investigated based on the information provided to date.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 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.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 scars, pain, stress, disability and weight gain are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported further kidney failure, loss of stamina, fear, and limited activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.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 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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.

Event Description

Patient alleges further kidney failure, loss of stamina, fear and limited activity.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & 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: 8319350
• MDR Text Key: 135494781
• Report Number: 3002808486-2019-00191
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019

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: 09/18/2016
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT
• Device Lot Number: E3134355
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/24/2019
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/14/2019; 10/22/2019
• Supplement Dates FDA Received: 03/13/2019; 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 102