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 Migration or Expulsion of Device (1395); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Device Tipped Over (2589); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Emotional Changes (1831); Pain (1994); Perforation (2001); Thrombosis (2100); Injury (2348); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog # unknown as information was not provided but referred to as either gunther tulip mreye, gunther tulip vena cava filter, cook celect vena cava filter, or cook celect platinum.Lot# unknown as information was not provided.Expiration date unknown as lot# is unknown.Unknown as information was not provided.As catalog# is unknown it could be either k000855, k032426, k061815, k073374, k090140, k112119, k121057 or k121629.Investigation is still in progress.

Event Description

Description according to complaint filed: it is alleged that "[pt] received an ivc filter" patient outcome: it is alleged "[pt] suffered permanent and continuous injuries, pain and suffering, disability and impairment.[pt] have suffered emotional trauma, harm and injuries that will continue into the future.[pt] has lost ability to live a normal life, and will continue to be so diminished into the future." hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).(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.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.

Event Description

Patient allegedly received an implant on (b)(6) 2014 via the right internal jugular vein due contraindication to anticoagulation therapy.Patient alleges migration, perforation (cat form claims).As per a ct scan performed on (b)(6) 2016, 'there is a filter in the ivc.There is mild penetration of the filter struts without evidence of bowel or spine impingement." successful filter retrieval performed on (b)(6) 2017.Per ct, (b)(6) : "presence of inferior vena cava filter with possible perforation of the legs of the filter through the vena caval wall.".

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(6) (importer).H6) device code: no code available (3191)-device perforation.G1) name and address for importer site: (b)(6).Registration no: (b)(4).Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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 and vena cava penetration.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).Potential adverse events that may occur include, but are not limited to, the following: filter migration and trauma to adjacent structures.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.

Event Description

Additional information provided the patient alleges filter placement due to prior deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging device tilt, pe, dvt, and post implant pain in addition to the previously reported vena cava and organ (jejunum) perforation.Patient notes and further alleges experiencing "a couple of dvts post implant and experience abdominal pains.I also experience anxiety, mental anguish and stress about the status of my filter and any related injuries" as well as worry.

Manufacturer Narrative

Additional information: h6 (patient and device codes).Investigation: the following allegations have been investigated: pe, dvt, tilt, abdominal pain, anxiety, mental anguish and stress and worry.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported abdominal pain, anxiety, mental anguish and stress and worry is directly related to the filter and unable to identify a corresponding failure mode at this point in time.There were twenty devices in the lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to specifications.There is 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 5366203
• MDR Text Key: 35922986
• Report Number: 3002808486-2016-00016
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2015
• Device Catalogue Number: IGTCFS-65-1-JUG-TULIP
• Device Lot Number: E3174783
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/05/2016
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 70