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 Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Transient Ischemic Attack (2109); Depression (2361); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a cook celect filter.Name and address for importer site: (b)(4).Pma 510(k): since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.(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 ¿celect filter implanted".Cook will reopen its investigation if further information is received 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) 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

Exemption number e2016032e lot.(b)(4).Additional information: investigation: 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, pe, difficult to retrieve, stroke, transient ischemic attack, depression'.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.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.Unknown if the reported stroke, transient ischemic attack, depression is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Celect filter 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.

Manufacturer Narrative

Exemption number e2016032.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

This additional information received on 08feb2017 as follows: pt allegedly received an implant on (b)(6) 2012 via the femoral vein due to pulmonary embolus(pe).Pt is alleging filter in place more than 90 days, too risky to attempt retrieval and future perforation and fracture are likely.Pt further alleges pulmonary embolisms, stroke, transient ischemic attack, depression.

Manufacturer Narrative

The additional information that was submitted under manufacturer report as follow-up #2 should have been submitted under manufacturer report as follow-up #3.As a result, this medwatch report is being submitted as a correction for this information.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

No additional information has been provided at this time.

• 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: 7120337
• MDR Text Key: 94927068
• Report Number: 3002808486-2017-02485
• 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,Followup,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2013
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2742687
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/30/2017
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 82