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

Catalog Number IGTCFS-65-1-FEM-CELECT

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

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); Dyspnea (1816); Injury (2348); Blood Loss (2597)

Event Date 06/01/2014

Event Type  malfunction  

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.Investigation is still in progress.

Event Description

Description according to short form complaint: it is alleged that "[pt] received a cook celect filter on (b)(6) 2013 at the (b)(6) university of (b)(6)." 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: igtcfs-65-1-fem-celect.Investigation is still in progress.

Event Description

Description according to short form complaint: it is alleged that "[pt] received a cook celect filter (b)(6) 2013 at (b)(6)".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) corrected data based on new information received: adverse event to product problem, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 04/11/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2013 via the left common femoral vein due to mcv with liver lacerations.Plaintiff is alleging device unable to be retrieved, embedded, chest pain, shortness of breath, nausea, anxiety.Plaintiff alleges attempted retrieval on (b)(6) 2014.

Manufacturer Narrative

Manufacturer ref# (b)(4).Exemption number e2016032.(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 "plaintiff is alleging device unable to be retrieved, embedded, chest pain, shortness of breath, nausea, anxiety, attempted retrieval on 06/01/2014¿.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.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 alleges bleeding.Attempted filter retrieval performed on (b)(6) 2014.As per a ct scan performed on (b)(6) 2014, it states "posterior tilt to the inferior vena cava filter with the hooks imbedded in the caval wall".

Manufacturer Narrative

Exemption number (b)(4).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 tilt.Name and address for importer site: (b)(4).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Additional information: investigation: the following allegations have been investigated: embedded, chest pain, shortness of breath, nausea, anxiety, tilt, bleeding.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.

• Brand Name: COOK CELECT NAVALIGN 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: 5459498
• MDR Text Key: 38965638
• Report Number: 3002808486-2016-00062
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2015
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT
• Device Lot Number: E2987458
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/03/2016
• Device Age: 19 MO
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 24 YR
• Patient Weight: 64