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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G52914
Device Problems Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Appropriate Term/Code Not Available (3191)
Patient Problems Chest Pain (1776); Fatigue (1849); Internal Organ Perforation (1987); Perforation of Vessels (2135); Thrombosis/Thrombus (4440); Insufficient Information (4580)
Event Type  Injury  
Event Description
It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2013, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
 
Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.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 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) 2013 via the right common femoral vein due to deep vein thrombosis (dvt)/ pulmonary embolism (pe).Patient is alleging vena cava perforation.Patient further alleges "chest pain." patient can no longer engage in "general movement due to fatigue and chest pain." per venogram, "venogram of the ivc demonstrating chronic caval thrombosis beginning within the ivc filter extending into the probable bilateral common/external iliac veins.The ivc at the level and below the filter is of small caliber with marked filling defect consistent with thrombus, prominent col laterals are identified.Filter apex is at the level of the caudal duplicated right renal vein, the ivc above the level of the filter is widely patent and of normal caliber.No filling defects are identified in the suprarenal cava.Therefore, ivc filter was left in place and retrieval was not attempted.Given that the patient is completely asymptomatic without complaints of swelling in the left above-the-knee amputation or right lower extremity, denying aching pain swelling to the legs, and given the chronicity of caval thrombosis with a small caliber infrarenal cava and firm fibrotic thrombus further intervention would likely be low yield and little benefit." per computed tomography report, "inferior vena cava filter is in place.Some of its struts demonstrate intraperitoneal perforation but no perforation today of any vital organs or bowel.One of the posterior medial struts appears to be in contact with the superior aspect of l4 vertebral body.".
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: a2, a4, b1, b5, b6, b7, d1, d4, g4, h4, h6 investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc) perforation, thrombus, unable to retrieve, chest pain, fatigue, limited physical activity.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: vascular trauma, vena cava perforation, vena cava penetration.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.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Unknown if the reported chest pain, fatigue, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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 Description
Per computed tomography report, "filter position: below the level of the renal veins." "the anterior right strut penetrates 20 mm through the ivc wall." "the anterior left strut penetrates 18 mm through the ivc wall." "the posterior right strut penetrates 13 mm through the ivc wall." "the posterior left strut penetrates 23 mm through the ivc wall.It penetrates into a vertebra where there are chronic reactive changes." "3 arms of the right penetrate through the ivc wall, 9 mm, 10 mm, and 10 mm.".
 
Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ perforation.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation does not change the previous investigation results for vena cava perforation.20 devices in lot.No relevant notes on wo for neither device (igtcfs-65-1-fem-celect) lot: e3088331, nor filter (igtf-30-celect) lot: e3071154 and e3071156.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 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.
 
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Brand Name
COOK CELECT NAVALIGN FEMORAL VENA CAVA FILTER SET
Type of Device
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
lissi walmann
sandet 6, dk-4632
bjaeverskov 
MDR Report Key15348456
MDR Text Key299168730
Report Number3002808486-2022-00934
Device Sequence Number1
Product Code DTK
UDI-Device Identifier10827002529141
UDI-Public(01)10827002529141(17)160516(10)E3088331
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/08/2022
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
Device Operator Health Professional
Device Expiration Date05/16/2016
Device Model NumberG52914
Device Catalogue NumberIGTCFS-65-1-FEM-CELECT
Device Lot NumberE3088331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/17/2022
Initial Date FDA Received09/02/2022
Supplement Dates Manufacturer Received09/27/2022
10/18/2022
Supplement Dates FDA Received10/11/2022
11/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient SexFemale
Patient Weight109 KG
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