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 Material Erosion (1214); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Thrombosis (2100); Perforation of Vessels (2135); No Information (3190)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(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) 2013".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).Investigation: investigation is reopened due to additional information provided.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 'vena cava and organ perforation, pain, swelling, struts eroding vc and duodenum, post implant dvt'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Unknown if the reported swelling is 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.(b)(4) devices in lot.No relevant notes on wo for neither device (igtcfs-65-1-jug-celect) lot# e3014764, nor celect filter lots# e3006186 and e3006197.One other complaint on lot ((b)(4)).Product is manufactured and inspected according to 1000363mi (device mi), 1001720qc (device qci), a43498 (celect mi), and a43590 (celect qci).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.

Event Description

This additional information received on 26/jan/2018 as follows: patient received an implant on (b)(6) 2013 via the right internal jugular vein due to pulmonary embolism.Patient is alleging vena cava and organ perforation, pain, swelling, struts eroding vc and duodenum and post implant dvt.Device was successfully retrieved on (b)(6) 2015.

Manufacturer Narrative

(b)(4).Exemption number e2016032.(b)(4).Corrected data based on new information received: adverse event to adverse event and product problem.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

Per ct, (b)(6) 2015: " an inferior vena cava filter is present inferior to the renal veins.Many of the inferior vena caval filter struts have eroded through the inferior vena cava wall.There is no pericaval hematoma.The struts indent the posterior aspect of the 2nd portion of the duodenum.One strut has eroded into the anterior aspect of the l3 vertebral body.".

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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.

• 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: 7141445
• MDR Text Key: 95586639
• Report Number: 3002808486-2017-02510
• 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,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E3014764
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/06/2017
• Device Age: 36 MO
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Weight: 77