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

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

Device Problems Bent (1059); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994); Thrombus (2101); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Catalog# is unknown but referred to as cook celect filter.(b)(6).Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.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) 2016".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 e2016032.(b)(4).Corrected data: adverse event and product problem to product problem.Outcomes to adverse event: other to .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, tilt, unable to retrieve, pain, permanent/ continuous injuries, blood clot, bent strut'.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.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.Unknown if the reported permanent/ continuous injuries 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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number e2016032.(b)(4).510 (k) k121629 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 16jan2018 as follows: ¿patient [pt] allegedly received an implant on (b)(6) 2016 via the right internal jugular vein due to deep vein thrombosis (left leg),recent postoperative hematoma.[pt] is alleging tilt and pain, permanent and continuous injuries without further explanation.[pt] further alleges blood clot without further explanation.Filter retrieval was attempted on (b)(6) 2016.The retrieval attempt was unsuccessful.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN JUGULAR 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: 7205017
• MDR Text Key: 97712035
• Report Number: 3002808486-2018-00147
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT-PT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2018
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Weight: 67