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

Catalog Number IGTCFS-65-1-JUG-TULIP

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Perforation (2001); Injury (2348); Blood Loss (2597); No Information (3190)

Event Date 08/01/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012.The [pt] states that both filters were placed at (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).Investigation is still in progress.

Event Description

Description according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012.The [pt] states that both filters were placed at (b)(6) center." 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).According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this 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 according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter and a cook celect filter on (b)(6) 2011 and on (b)(6) 2012." 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 was received on 09jun2016 as follows: plaintiff allegedly received an implant on (b)(6) 2012 via the jugular vein due to knee replacement surgery.Plaintiff also allegedly received a first filter implanted on (b)(6) 2011 ((b)(4)).Plaintiff is alleging the second filter is unable to be retrieved.Patient alleges successful retrieval of the first filter on (b)(6) 2011.Patient alleges attempted retrieval of the second filter on (b)(6) 2012.

Manufacturer Narrative

Manufacturer reference # (b)(4).Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).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 "plaintiff is alleging the filter is unable to be retrieved¿.Cook will reopen its investigation if further information is received.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.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

Patient alleges migration, penetration/perforation, fracture, bleeding, death, open removal (cat form).

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) (b)(4).Additional information: investigation: unknown if reported patient death is related to filter.Vena cava wall penetration/perforation has been reported and may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; and (or) excessive force or manipulations near an in situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).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 bleeding is directly related to the filter.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.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: GUNTHER TULIP 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: 5690403
• MDR Text Key: 46256534
• Report Number: 3002808486-2016-00340
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2015
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E2884459
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2016
• Device Age: 4 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: 63 YR
• Patient Weight: 103