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 Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Edema (1820); Occlusion (1984); Thrombosis (2100); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog # is unknown but referred to as cook celect filter.Initial reporter 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

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

No additional information provided at this time.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer blank fields on this form indicate the information is unknown or unavailable, or unchanged.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.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-pt, ivc occlusion, thrombosis, tilt, dvt, edema, medical monitoring, endovascular procedures'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Ivc filter thrombus, or clot in ivc filter, is an outcome where the filter has either entrapped a clot that has embolized from an upstream source, such as a deep vein thrombus, or where a clot has formed on or within the filter.Filter thrombus can either resolve through the process of thrombolysis, remain stationary without subsequent sequelae, or alternatively provide a nidus for additional clot formation.The presence of a filter thrombus could preclude the removal of the filter during a retrieval process due to potential dislodgement of the thrombus which could cause a downstream occlusive event, e.G.Pulmonary embolism.Ivc filter thrombus is documented by ultrasound (us), ct, mr imaging or venography.Unknown if the reported medical monitoring or endovascular procedures are directly related to the filter and unable to identify corresponding failure mode(s) at this time.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time.No relevant notes found on work order or device lot.No other complaints on lot.Product 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.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

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).H6) patient code: occlusion (1984)-listed in the ifu,thrombosis (2100)-listed inn ifu,edema (1820)-not listed in ifu.Device code:unintended movement (3026)- listed in the ifu.G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.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.

Event Description

Patient allegedly received an implant on (b)(6) 2014 via the common femoral vein due to right lower extremity pulmonary embolism, deep vein thrombosis, renal tumor.Patient alleges tilt, chronic ivc occlusion into the pelvis, 100% ivc occlusion, recurrent/extensive rle deep vein thrombosis, medical monitoring, ivc filter occlusion, chronic lower extremity edema secondary to occluded ivc filter, thrombectomy/angiojet procedure.

• 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 4632
• MDR Report Key: 7973079
• MDR Text Key: 123937706
• Report Number: 3002808486-2018-01183
• 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
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2017
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3262150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/27/2018
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening