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 Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Anemia (1706); Hemorrhage/Bleeding (1888); No Information (3190)

Event Date 05/14/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog is unknown but referred to as cook celect filter.Expiration date: unknown as lot # is unknown.(b)(4).Since catalog # is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date unknown as lot # is unknown.Investigation is still in progress.

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

(b)(4).Unknown if the following patient and device codes are listed in the ifu.Product information not provided.(b)(4).Name and address for importer site: (b)(4).Corrected data based on new information received: adverse event to product malfunction, serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

This additional information received on 07/14/2017 as follows: patient allegedly received an implant on (b)(6) 2013 via the right internal jugular vein due to extensive lower extremity dvt, secondary to may-thurner's syndrome.Patient alleges attempted retrieval on (b)(6) 2013.Patient is alleging device is unable to be retrieved, bleeding, pe, thrombosed ivc below the filter, life long anticoagulation, gi bleed, anemia.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4), corrected data based on new information received: serious injury to malfunction.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 ¿unable to be retrieved, bleeding, pe, thrombosed ivc below the filter, anticoagulation, gi bleed, anemia".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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.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.Unknown if the reported bleeding, anticoagulation, gi bleeding, and anemia are directly related to the filter and unable to identify a corresponding failure mode at this point in 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: 6597270
• MDR Text Key: 76126448
• Report Number: 3002808486-2017-01200
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/15/2017
• Device Age: 9 MO
• Date Manufacturer Received: 09/15/2017
• Date Device Manufactured: 08/01/2012
• 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: 78 YR
• Patient Weight: 56