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

Catalog Number IGTCFS-65-2-UNI-CELECT

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Internal Organ Perforation (1987); Pain (1994); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Investigation is still in progress.

Event Description

According to the initial reporter: in about (b)(6) 2013 at hospital in (b)(6), the patient had an intravenous vena cava filter inserted in a vein running alongside her abdomen to stop blood clots from her legs entering her lungs and heart.' in (b)(6) 2014, our client attended at the hospital and had a thromboendarterectomy, whereby the blood clots in her lungs were removed and her pulmonary arteries were "bored out".She was placed on blood thinning medication.It is thought that she no longer required an ivc filter given no further pulmonary embolism has occurred since that surgery and once on the anticoagulation regime.However, neither the surgeon at the time nor her treating medical providers since have considered removing the ivc filter.The patient had complaints of pain in the heart for some time and despite tests everything appeared satisfactory.More recently in (b)(6) 2021 the patient had a fall.Radiological and other investigations undertaken post the fall inadvertently uncovered that the ivc filter had disintegrated and broken apart and that six struts from the ivc filter have migrated through her veins into different organs in her body.On the mri it was seen that a strut from the ivc in the right kidney, two struts in the right heart ventricle, and the ct report of (b)(6) 2021 suggests that there is at least one but probably two ivc limbs dispersed and lodged in her liver.There are also two struts lodged on the lower thoracic spine.They are in precarious positions.The ivc filter itself has moved and is now at the level of the left renal vein with limbs in situ behind the vessel wall.The enclosed report of cardiologist dated (b)(6) 2021 records that patient has been complaining of sharp, central sternal chest pain for the last five months but in effect, she has been experiencing such pains for quite a bit longer than that.Relevant additional information added from medical records: diagnosed when presented to hospital after a fall with some back pain on the right hand side, was reviewed by inpatient cardiothoracic's and vascular and was deemed too high risk for surgery.Uncertain timing of limb fractions and embolisation.On home oxygen.Until 18 months ago was on nocturnal oxygen only, but since then has been on 24-hour oxygen due to worsening shortness of breath.Of more recent, pressing concern is the story of the ivc filter embolization.[pt] presented here in march after a fall, complaining of right-sided back pain.A ct scan was done to look for any signs of haematoma on the kidney, because of the pain.Unfortunately what they discovered that she had a limb of the ivc filter in her kidney on the right, there was also a limb of the ivc filter in her liver.The ct abdomen showed also limbs in the heart, and she had a ct chest done showing that indeed she had two limbs in her right heart.We do not know when these limbs embolised, and they could have been there for years, for all we know, or it could have been relatively recent as well.Her last ct of her chest was in 2018, a ctpa, and it did not show any of the limbs in her heart.Interestingly, the limbs do not appear on her cxr done at the same time as the ct scan this year that showed the limbs.What is concerning, however, is that [pt] had been complaining of a sharp, central, sternal chest pain as well as beneath her left breast, over the last five months.She described it as a razor blade-like pain that comes on with no particular pattern.It can be on exertion or at rest, but when she gets ii she stops what she is doing, has a rest, and waits for it to go away.It can last anywhere from 5 minutes to over an hour.She is a bit unsure as to the frequency of this pain, at this point in time.On examination today her blood pressure was 100/55 mmhg, and she weighed (b)(6).Her chest examination revealed poor air entry generally but no additional breath sounds.Her jvp was not raised: she did not have any obvious right heart heave on examination.Heart sounds were dual with no obvious murmurs.Her abdomen was soft and non-tender, and she had no signs of peripheral oedema, although she does report occasional peripheral oedema.Radiology report: ivc filter noted: at the level of the left renal vein with limbs protruding beyond the vessel wall.Of note, there is a linear hyper density within the inferior pole of the liver and the right renal lower pole, suspicious for embolization of ivc limbs.Two embolised ivc filler limb, are present in the heart.The first lies anteriorly in the antero-inferior aspect of' the right ventricular myocardium, it is inferior portion extends beyond the myocardium/pericardium into the epicardial fat by approximal 5mm.The overall length of the limb is approximately 30 mm.Patient outcome: no unintended part of the device remained inside the patient's body.The original ivc filter remains insitu but had disintegrated and broken apart and that six struts from the ivc filter have migrated through her veins into different organs in her body.It is a difficult and life-threatening surgery to have the struts removed from her heart and it is difficult and dangerous surgery to remove them from her spine.It is thought the surgery would kill her.This is because of our clients' medical conditions.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter was placed in (b)(6) 2013 after multiple recurrent pulmonary embolisms despite anticoagulation.The patient had a complicated medical history and whilst being prepared for a lung transplant, a pulmonary thromboendarterectomy was done instead in (b)(6) 2014.The procedure was successful although complicated by a left hemidiaphragm palsy.Anticoagulation was restarted, but for unknown reasons the ivc filter was never removed.In 2021 after complaints of chest and abdominal pains, ct scans revealed a fractured ivc filter with several migrated limbs lodged in the kidney, liver and two in the heart.No further pes occurred during follow-up, and it was noted that the need for a ivc filter no longer existed.For unknown reasons no filter removal was attempted.Filter fracture and embolization is a well-recognized potential complication and described in the ifu.Nevertheless, the migrated filter limbs have been clearly documented in this case and their positions may lead to potentially serious and life-threatening clinical consequences.Filter fracture may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook was unable to conduct a review of the device history record, as the lot number of the complaint device was not provided for the investigation.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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 regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the filter was placed in (b)(6) 2013 after multiple recurrent pulmonary embolisms despite anticoagulation.The patient had a complicated medical history and whilst being prepared for a lung transplant, a pulmonary thromboendarterectomy was done instead in (b)(6) 2014.The procedure was successful although complicated by a left hemidiaphragm palsy.Anticoagulation was restarted, but for unknown reasons the ivc filter was never removed.In 2021 after complaints of chest and abdominal pains, ct scans revealed a fractured ivc filter with several migrated limbs lodged in the kidney, liver and two in the heart.No further pulmonary embolisms occurred during follow-up, and it was noted that the need for a ivc filter no longer existed.For unknown reasons no filter removal was attempted.Filter fracture and embolization is a well-recognized potential complication and described in the ifu.Nevertheless, the migrated filter limbs have been clearly documented in this case and their positions may lead to potentially serious and life-threatening clinical consequences.Filter fracture may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.It was assessed that because any discovered non-conformances were properly dispositioned before final release, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Except from the dhr the above and previously investigation dated 09aug2022 is still valid and remains unchanged.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS
• 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 Key: 14237969
• MDR Text Key: 290303737
• Report Number: 3002808486-2022-00283
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002529219
• UDI-Public: (01)10827002529219(17)160315(10)E3060097
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2023

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 Date: 03/15/2016
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT
• Device Lot Number: E3060097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 08/09/2022; 02/03/2018
• Supplement Dates FDA Received: 08/10/2022; 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Female
• Patient Weight: 80 KG