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

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

Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Anxiety (2328); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog # is unknown but referred to as cook celect platinum 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

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2016".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Manufacturer Narrative

Exemption number e2016032.(b)(4).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.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 its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Additional information: investigation: this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.

Event Description

As per an xray performed on (b)(6) 2017, it states " metallic wire fragments project over the right heart, near the junction of the right atrium and right ventricle." per x-ray, (b)(6) 2018: " remonstration of metallic wire fragment which projects over the right heart.".

Event Description

Patient allegedly received an implant on (b)(6) 2016 via the right common femoral vein due to deep vein thrombosis, pulmonary embolism and recent surgery with bleeding.Patient is alleging migration, fracture, device unable to be retrieved multiple times due to embedment, fragment embedded in right ventricular apex, and unable to retrieve broken fragment.Patient is further alleging they suffered from fear ad anxiety after the first experience of the failed retrieval attempt of the device."during the first surgery, the failed attempts to remove it and could feel doctors tugging the device, causing a severe emotional episode.Between (b)(6) 2016 and (b)(6) 2017, patient alleged suffering severe distress over the fact that the device could not be removed.After the complex removal of the device and upon finding out that a piece of the ivc filter was lodged in the heart, patient suffered from constant fear and anxiety that it could fatally puncture the heart.As a result of the unsuccessful retrieval surgeries, patient alleges suffering traumatic episodes when visiting medical facilities." retrieval attempts (unsuccessful) (b)(6) 2016 and (b)(6) 2017.Successful retrieval (b)(6) 2017.

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.Patient code: anxiety (2328) - not listed in ifu, device fragments in patient (3165), not listed in ifu.Device code: difficult to remove (1528) - not listed in ifu, fracture (1260) - listed in ifu, break (1069) - not listed in ifu.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.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Name and address for importer site: (b)(4).Additional information- investigation- it has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect-pt, fracture (in situ), difficult to retrieve (emb'd), migration, fear, anxiety'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), excessive force or manipulations near an implanted filter (e.G.A surgical procedure in the vicinity of a filter) and / or procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that a filter fragment embolized into the heart or lung may be safely retrieved.A filter that is embedded in the wall of the ivc may be difficult to retrieve.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported fear, anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this 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 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.

• Brand Name: COOK CELECT® PLATINUM 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
• MDR Report Key: 7994402
• MDR Text Key: 124659907
• Report Number: 3002808486-2018-01226
• 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,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3390660
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/04/2018
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 50