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

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); Depression (2361); Bowel Perforation (2668); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.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

'it is alleged that "[pt] received a cook celect filter on (b)(6) 2008".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

(device code): appropriate term/code not available (3191) for device perforation.(device code): appropriate term/code not available (3191) for device tilt.Investigation is reopened due to additional information provided.The following allegations have been investigated.Vena cava perforation, organ perforation, tilt, depression, anxiety, chest pain, limited activity/activities daily living.The reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This 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, vena cava penetration.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 depression, anxiety, chest pain, limited activity/activities daily living is 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.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.

Event Description

Patient allegedly received an implant on (b)(6) 2008 via the right internal jugular vein due to right heart failure with pulmonary embolism.Patient is alleging device tilt, vena cava and organ perforation.Patient notes and further alleges "prong has perforated the bowel.10 prongs have perforated the ivc at 7mm distance.Filter has also tilted.Also have burning chest pain and discomfort".Additional patient notes limited physical activity and activities of daily living (adl).Per the (b)(6) 2008 filter placement report: "this showed a duplicated left renal vein and just below this lower left renal vein, a vena cava filter was placed.This is a select filter which is either retrievable or can be left in as a permanent filtration".Per an independent review of a (b)(6) 2017 ct of the abdomen and pelvis scan: "¿positive for cava/ perforation.Superior extent of ivc filter is at the l2-l3 disc space.Inferior extent mid l4 vertebral body.A total of ten prongs have perforated the ivc, series 4, image 198.Maximum distance prong perforated is 7 mm, series 4, image 198.Coronal images show 5-degree tilt right-to-left, series 401, image 78.Sagittal images show 4-degree tilt posterior-to-anterior, series 400, image 66.Diameter of ivc directly above filter measures 7 mm x 16 mm, series 4, image 158.Attention: a prong has perforated bowel, best appreciated on series 4, image 183".

• Brand Name: 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: 9144825
• MDR Text Key: 160853432
• Report Number: 3002808486-2019-01584
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2009
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2037766
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 82