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
Medical Device Problem Codes	Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person) not provided, information provided by (b)(4).Occupation: non-healthcare professional.Investigation: 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.Rpn/lot is unknown, however, the device is manufactured and inspected according to current controls.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 information become available.
Event or Problem Description
It is alleged that "patient received a cook celect filter.Patient is alleging perforation of organ.Hospital and medical records have not been provided.".
Additional Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava/aorta perforation and tilt.The reported allegations have been further investigated based on the information provided to date.The additional information regarding vena cava /aorta perforation does not change the previous investigation results for organ perforation.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.Catalog number and lot number are unknown, however, the alleged celect 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 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 or Problem Description
It is alleged that patient received cook celect inferior vena cava (ivc) filter on (b)(6) 2014.The patient alleged that the filter perforated through ivc.One strut further perforates patient's aorta, and the filter also substantially tilted.
Additional Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ/vena cava (vc)/aorta perforation, tilt, anxiety, worry, fear, limited physical activity.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.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 anxiety, worry, fear, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.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.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 or Problem Description
Additional information has been received as follows: patient received the celect filter on 03sep2014 due to deep vein thrombosis (dvt).Patient alleges organ and vena cava perforation.Patient notes and further alleges experiencing anxiety, worry, fear, limited physical activity.Per a report from computed tomography (ct): "findings: this dictation refers only to the ivc filter.Caval perforation: yes.Grade 4 perforation 3 o'clock leg into aorta.Grade 2 perforation of 12 o'clock leg 0.85 cm.Grade 1 perforation of 9 o'clock leg 0.30 cm.Tilt: yes.16.57 degrees of sagittal angulation.No substantial coronal angulation.Apex of filter abuts and tents posterior ivc.Migration: no.Pertinent negatives: no definite fracture or missing struts.No ivc stenosis.Additional findings: no".

• Brand Name: NAVALIGN COOK CELECT JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14444910
• Report Number: 3002808486-2022-00685
• Device Sequence Number: 4436210
• Product Code: DTK
• UDI-Device Identifier: 10827002529097
• UDI-Public: (01)10827002529097(17)170710(10)E3235445
• Combination Product (Y/N): N
• PMA/510(K) Number: K090140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2017
• Device Catalogue Number: IGTCFS-65-1-JUG-CELECT
• Device Lot Number: E3235445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 11/15/2023; 03/20/2024
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 12/07/2023; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Weight: 93 KG