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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Perforation of Vessels (2135); Disability (2371); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date: unknown as lot# is unknown.(b)(4).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2012." 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

(b)(4).Catalog #: unknown but referred to as a cook celect filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date unknown as lot # is unknown.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 according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2012." 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

(b)(4).The event is currently under investigation.

Event Description

Per additional information provided on 02/13/2017: it is alleged that the device is unable to be retrieved without further details.It was reported that patient experienced pain, suffering and disability.

Manufacturer Narrative

(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.

Manufacturer Narrative

Manufacturer reference #: (b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: to product problem, to malfunction.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 'celect, unable to retrieve, pain, suffering, disability'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Unknown if the reported pain, suffering and disability is directly related to the filter and unable to identify corresponding failure mode(s) at this 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.

Event Description

Patient allegedly received an implant via the right common femoral vein due to prophylaxis.Patient is alleging device tilt, vena cava perforation, fracture, tip embedded in lateral wall of ivc, perforation of ivc greater than 3mm, 6 smaller legs identified.Should have 8.Possible filter fracture, other (unspecified).The patient notes and further alleges "will require ongoing medical care and concerns that he will suffer additional injury and/or death because of the retained filter".

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.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation h6 device code(s): appropriate term/code not available (3191) was selected for the alleged device tilt.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

No additional information to provide 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: tilt, vena cava perforation, fracture, embedded.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.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.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.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 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: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 4632 ; DA 4632
• MDR Report Key: 5852851
• MDR Text Key: 51340234
• Report Number: 3002808486-2016-00836
• 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
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2019

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 Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2016
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/05/2017; 06/07/2019; 07/29/2019
• Supplement Dates FDA Received: 01/10/2017; 03/15/2017; 05/02/2017; 09/11/2017; 06/28/2019; 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Weight: 100