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

Catalog Number IGTCFS-65-FEM-CELECT-PERM

Device Problems Structural Problem (2506); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Erosion (1750); Internal Organ Perforation (1987); Pain (1994); Urinary Tract Infection (2120); Perforation of Vessels (2135); Stenosis (2263); 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.(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.

Event Description

It is alleged that "[pt] received a cook celect filter on (b)(6) 2010".It is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

It is alleged that patient received a cook celect filter on (b)(6) 2010.Patient is alleging migration, bleeding, erosion, right hydronephrosis in kidney.Patient further alleges pain, urinary tract infections, bleeding.Attempted retrieval, due to right ureter erosion, performed on (b)(6) 2018, without further details.On (b)(6) 2017,ct:redemonstration of an ivc filter with multiple legs extending adjacent to the right ureter and right common iliac artery.The mild dilatation of the right ureter is unchanged.Contrast opacification of the inferior vena cava at that level of the filter is poor.The presence of multiple venous collaterals and small size of the ivc at the level of the filter raises suspicion for possible persistent thrombus within the filter.If it changes clinical management, a conventional venogram could be performed for confirmation.Per ct, (b)(6) 2018: there is redemonstration of extruded limbs through the ivc from ivc filter.The ivc is small in caliber at this level with numerous chronic venous collaterals.Per ct, (b)(6) 2018: the patient's inferior vena cava is small in caliber.There is an inferior vena cava filter which is unchanged in appearance wit multiple limbs outside the lumen.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404.Registration no.: 3005580113.Additional information: investigation: the reported allegations have been further investigated based on the information provided to date.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, trauma to adjacent structures.Unknown if the reported bleeding, erosion, right hydrocephrosis kidney, pain, urinary tract infections are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No relevant notes found on work order or device lot.No other complaints on lot.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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.Cook will reopen its investigation if further information is received 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.

Manufacturer Narrative

Additional information: investigation ¿ investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.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, trauma to adjacent structures.Unknown if the reported bleeding, erosion, right hydrocephrosis kidney, pain, urinary tract infections are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The following allegations have been investigated: migration, bleeding, erosion, right hydrocephrosis kidney, pain, urinary tract infections.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 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

No additional information provided at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b1, b2, b5, b6, h6 (patient and device codes).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ/vena cava perforation, ureteral stricture.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.Unknown if the reported ureteral stricture is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on wo for neither device (igtcfs-65-fem-celect-perm) lot: e2629212, nor filter (igtf-30-celect) lot: (e2607329 + e2606490).No other complaints on lot.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.

Event Description

Per cystourethroscopy report, "retrograde ureteropyelography showed right-sided hydronephrosis with a filling defect in the right proximal ureter at the ivc filter; however, there was no contrast extravasation on filling or delayed imaging." per cystcopy report, "he had cross-sectional imaging that showed an ivc filter rotating through the ivc and into the right ureter." "at that time we noted a fiper cystourethroscopy report, "retrograde ureteropyelography showed right-sided hydronephrosis with a filling defect in the right proximal ureter at the ivc filter; however, there was no contrast extravasation on filling or delayed imaging." per cystcopy report, "he had cross-sectional imaging that showed an ivc filter rotating through the ivc and into the right ureter." "at that time we noted a filling defect at the level of the ivc and a ureteral stent was placed at that time." "right proximal ureter was dissected free from surrounding tissue in the retroperitoneum and the area of stricturing in heavy fibrosis was freed from the ivc filter erosion." "we identified the level of stricturing with an ivc filter prong eroding through the ivc and into the right ureter.We were able to carefully dissect the ureter away from the eroded ivc filter prong." per computed tomography (ct): "the patient has a history of right proximal ureteral stricture secondary to ivc filter erosion and is status post right ureteroplasty and ureterolysis"."an ivc filter is noted."lling defect at the level of the ivc and a ureteral stent was placed at that time." "right proximal ureter was dissected free from surrounding tissue in the retroperitoneum and the area of stricturing in heavy fibrosis was freed from the ivc filter erosion." "we identified the level of stricturing with an ivc filter prong eroding through the ivc and into the right ureter.We were able to carefully dissect the ureter away from the eroded ivc filter prong.".

Manufacturer Narrative

Investigation: investigation is 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.The associated work order was reviewed.No related/relevant notes were documented.No other complaints on lot.Product is manufactured and inspected according to specifications.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 the celect filter (b)(6) 2010 via the right femoral vein.

• Brand Name: COOK CELECT 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 DK-46 32; DA DK-4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 8598216
• MDR Text Key: 144663226
• Report Number: 3002808486-2019-00575
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2012
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2629212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/23/2019
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male