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

Catalog Number IGTCFS-65-1-UNI-CELECT-PT

Device Problems Complete Blockage (1094); Difficult to Remove (1528)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Pain (1994); Dizziness (2194)

Event Type  Injury  

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.Investigation is still in progress.

Event Description

Description of event according to complainant: it is alleged that "[pt] was implanted with a cook celect ivc filter.In (b)(6), 2015, [pt] experienced shortness of breath and attended (b)(6) hospital.He was advised that he had blood clots in his lungs and underwent a procedure to implant the ivc filter.He was also placed on injectable fragmin (anticoagulant).He was admitted to the hospital for approximately three and a half months.In (b)(6) 2015, while admitted, [pt's] physicians attempted to remove the implanted ivc filter.This procedure, which was approximately 30 minutes in length and performed under conscious sedation, was unsuccessful.[pt] was discharged from the hospital with the filter in place and remained on fragmin.In (b)(6) 2016, [pt's] physicians performed a second unsuccessful attempt to remove the implanted ivc filter.This procedure lasted approximately three and half hours under conscious sedation.[pt] describes the procedure as very painful and traumatic with multiple unsuccessful attempts that were made to remove the device.[pt] is scheduled to undergo a third attempt at removal on (b)(6) 2015 at (b)(6) hospital.[pt] has been advised by his physicians that it is likely that they will not be able to remove the ivc filter." patient outcome: "recently, [pt] has experienced dizzy spells.He has been advised by his physicians that his ivc filter may be becoming clogged, blocking his blood flow." 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.Summary of investigational findings: patient's medical records are unknown at this time and no imaging is provided.Therefore, no conclusion can be drawn based on the incomplete information provided on reported unsuccessful retrieval attempts approx.2 and 5 months after filter placement and it is unknown, if the scheduled third attempt was made.Furthermore, no conclusion can be drawn based on the incomplete information about the filter, which allegedly recently may "be becoming clogged, blocking his blood flow" and the dizzy spells, the patient has experienced.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.Reference is made to ifu, potential adverse events: pulmonary embolism, filter embolization, vena cava occlusion or thrombosis.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.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: it is alleged that "[pt] was implanted with a cook celect ivc filter.In (b)(6) 2015, [pt] experienced shortness of breath and attended (b)(6) hospital.He was advised that he had blood clots in his lungs and underwent a procedure to implant the ivc filter.He was also placed on injectable fragmin (anticoagulant).He was admitted to the hospital for approximately three and a half months.In (b)(6) 2015, while admitted, [pt's] physicians attempted to remove the implanted ivc filter.This procedure, which was approximately 30 minutes in length and performed under conscious sedation, was unsuccessful.[pt] was discharged from the hospital with the filter in place and remained on fragmin.In (b)(6) 2016, [pt's] physicians performed a second unsuccessful attempt to remove the implanted ivc filter.This procedure lasted approximately three and half hours under conscious sedation.[pt] describes the procedure as very painful and traumatic with multiple unsuccessful attempts that were made to remove the device.[pt] is scheduled to undergo a third attempt at removal on (b)(6) 2015 at toronto general hospital.[pt] has been advised by his physicians that it is likely that they will not be able to remove the ivc filter." patient outcome: "recently, [pt] has experienced dizzy spells.He has been advised by his physicians that his ivc filter may be becoming clogged, blocking his blood flow." hospital and medical records have been requested but not yet provided.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).E3) attorney.Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.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

Manufacturer ref# (b)(4).Summary of investigational findings: 04oct2021: complaint reopened since lot no e3332358 was provided.However, since the lot# is the only additional information provided, the investigation dated 27sep2016 is still valid and remains unchanged.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.Cook medical will continue to monitor for similar events.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA
• MDR Report Key: 5771386
• MDR Text Key: 48819331
• Report Number: 3002808486-2016-00678
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2018
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3332358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening