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); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Injury (2348); Blood Loss (2597); No Information (3190)

Event Date 07/31/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but refered 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 or k090140.Mfr date: unknown as lot# is unknown.Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011 at (b)(6) hospital in (b)(6)".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

(b)(4).Catalog#: igtcfs-65-1-jug-celect.(b)(4).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011".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

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 06/20/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2011 via the right jugular vein due to blood clots, recurrent pe, and dvt.Plaintiff is alleging filter migration, vena cava perforation, fracture, bleeding, organ perforation, and back pain.Patient alleges successful retrieval on (b)(6) 2014.The report provided by the center that allegedly retrieved the filter notes that the "ivc filter was then inspected and was noted to be intact," in conflict with the plaintiff's allegation of filter fracture.

Manufacturer Narrative

Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference # (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 'migration, vena cava perforation, fracture, bleeding, organ perforation, back pain'.Cook will reopen its investigation if further information is received.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, 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.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.Unknown if the reported back pain is directly related to the filter and unable to identify a corresponding failure mode 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
• Manufacturer Contact: thomas hessner kirk ; 400 daniels way; bloomington, IN 47404 ; 8004574500
• MDR Report Key: 5818463
• MDR Text Key: 50294065
• Report Number: 3002808486-2016-00780
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/20/2016
• Device Age: 41 MO
• Date Manufacturer Received: 07/26/2017
• Date Device Manufactured: 02/17/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR
• Patient Weight: 59