MAUDE Adverse Event Report: WILLIAM COOK EUROPE; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Angina (1710); Chest Pain (1776); Dyspnea (1816); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: lnu k.Et al "shot through the heart : angina like symptoms due to inferior vena cava filter fracture migrating to intercostal space, jacc journal, may 2021, vol.77 no.18.Catalog# is unknown but referred to as cook celect filter.Pma/510(k): k171712.Investigation is still in progress.

Event Description

According to article.Inferior vena cava (ivc) filters have been associated with multiple complications.We present a case of an elderly female who presented 8 years after the filter implantation and was found to have developed pericardial effusion secondary to filter fracture and migration of the strut to the intercostal space.A (b)(6) female presented with severe angina mimicking chest pain for two weeks.Her past medical history was significant for implantation of a cook celect retrievable ivc filter (> 8 years ago).She had been lost to follow up.Labs revealed troponin i of 0.06 ng/ml.An ekg showed atrial flutter with variable atrio-ventricular block.Chest x-ray revealed a metallic foreign body at the left of midline and along the anterior chest wall below the level of the sternum.A ct angiogram demonstrated a large pericardial effusion measuring 2.5 cm.At the anterior margin of the pericardium, extending into the anterior soft tissues of the chest wall was a linear density.However, the metallic object was not to be located in the right ventricle and the tip was suggested to be in the pericardium.The foreign body was considered a fragment of the ivc filter.The patient's symptoms of chest pain and dyspnea were considered to occur when the filter was migrating through the pericardium and the pain became sharper once it was embedded in the intercostal space.An urgent subxiphoid pericardial window for removal of the foreign body was performed along with xiphoidectomy.Fluoroscopy indicated that the metallic fragment was an ivc filter fragment and was embedded in the sixth intercostal space along the left side.It was then removed along with evacuation of 250 cc of bloody fluid.

Event Description

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

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: eight years after celect filter placement the patient developed pericardial effusion secondary to filter fracture and migration of the strut to the intercostal space.The fragment was removed, but no information as to the filter.No product was returned for investigation and based on the limited information provided the exact reason for the filter to fracture during an eight-year dwell time cannot be determined.However, it is noted that the patient was lost for follow up.Filter fracture has been reported and 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 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.

• 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 ; 56868686
• MDR Report Key: 12286016
• MDR Text Key: 265361369
• Report Number: 3002808486-2021-01681
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female