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

Catalog Number IGTCFS-65-1-JUG-CELECT

Device Problems Fracture (1260); Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Chest Pain (1776); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog#: unknown but referred to as a cook celect filter.(b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119 or k121057.(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 "patient received a cook celect filter on (b)(6) 2012".It is alleged that patient was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturer ref# (b)(4).(b)(4).Pma/510 k: k090140.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 2jan2018 as follows: ¿patient [pt] allegedly received an implant on (b)(6) 2012 due to deep vein thrombosis.[pt] is alleging fracture, and embolized filter.[pt} further alleges physical activities became difficult, chest pain ensued in multiple occasions.Filter retrieval was attempted on (b)(6) 2012 due to fractured filter arm to right pulmonary artery requiring retrieval and was unsuccessful.Filter retrieval was attempted again on (b)(6) 2012 (complex retrieval).The filter was removed including the fractured arm.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Manufacturer ref# (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, fracture (embolized leg), chest pain, difficult to retrieve (embedded), tilt'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.A filter that is embedded in the wall of the ivc may be difficult to retrieve.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.Unknown if the reported physical activities difficulty 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.

• Brand Name: NAVALIGN COOK CELECT 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: 7120334
• MDR Text Key: 94927446
• Report Number: 3002808486-2017-02458
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/30/2017
• Date Manufacturer Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 75