MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-1-UNI-CELECT-PT

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Pain (1994); Scar Tissue (2060); 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) 2017".It is alleged that "[pt] was injured without further explanation".Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a4, b1, b2, b5, b6, b7, and h6.Investigation the investigation was reopened due to additional information provided.The following allegations have been investigated: scar tissue, additional surgery requirement, unspecified damage, abdominal/chest/back pain, swelling of legs/hands, and shortness of breath.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported scar tissue, additional surgery requirement, unspecified damage, abdominal/chest/back pain, swelling of legs/hands, and shortness of breath 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.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 medwatch report will be submitted if additional relevant information becomes 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

Patient allegedly received an implant on (b)(6) 2017 due to pe (pulmonary embolism) and dvts (deep vein thromboses).Patient is alleging scar tissue and that additional surgery was required due to unsuccessful filter retrieval attempt.The patient is further alleging unspecified damage and "pain in abdomen area radiating to left side of chest and to back, swelling in both legs and hands and shortness of breath.".

Manufacturer Narrative

Appropriate term/code not available (4316) was selected for the investigation conclusion.The investigation was reopened due to additional information provided.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.20 devices in lot.No other complaints on lots.Product is manufactured and inspected according to specifications.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 medwatch report will be submitted if additional relevant information becomes 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

Per an unsuccessful retrieval report dated (b)(6) 2018, "prepped and draped in sterile fashion.Right ijv entered with large sheath over a wire using ultrasound guidance.Venogram of the ivc done.Attempt at retrieval of the filter unsuccessful using standard techniques.Sheath removed and pressure held at the right neck." per a successful retrieval report dated (b)(6) 2018, "contrast was injected for inferior venacavogram, demonstrating wide patency of the ivc.There was no evidence for thrombus within the filter." "the filter was removed in its entirety.".

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 8775180
• MDR Text Key: 150528900
• Report Number: 3002808486-2019-00959
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3614844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 107