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

Catalog Number UNKNOWN

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog # is unknown but referred to as cook celect platinum filter.(b)(4).Similar to device under 510(k)/pma k121629.(b)(4).Based on article: prolonged balloon tamponade in the initial management of inferior vena cava injury following complicated filter retrieval, without the need for surgery.Lee et al.2018.Investigation is still in progress.

Event Description

Description of event according to article: a gunther-tulip retrieval kit was used (cook medical).Cavography demonstrated a tilted filter with penetrating legs.A loop snare technique was successful, however, upon retrieval, venography showed a pseudoaneurysm and hemorrhage.Bleeding ceased after inflation of a 16 x 40 mm balloon across the injured segment for 20 minutes.Post-procedure computed tomography (ct) showed minimal perivascular hematoma.Anticoagulation was not continued after the filter retrieval.Two weeks following the injury, the patient presented with abdominal pain and bilateral lower limb oedema.A ct venogram revealed ivc and iliofemoral vein thrombosis.Patient outcome: to manage the patient representation with pain, she was managed with anticoagulation therapy and compression stockings, with significant improvement in her lower limb swelling at 10 months post-injury and no venous claudication.

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: it was found during article review that following pe a patient received an ivc celect pt filter.After 6 months dwell time the filter was retrieved using a 'loop snare technique' but pseudoaneurysm and haemorrhage was reported post-procedure.At the 2 week follow-up, the patient presented with abdominal pain, bilateral lower limb oedema and iliofemoral vein thrombosis.Per image review findings, the initial venogram shows a 6° leftward tilt and most primary legs extend 3 mm outside of the column of contrast indicating penetration.The venacavogram taken immediately following retrieval, demonstrates focal outpouching of the contrast in the infrarenal location consistent with a pseudoaneurysm and what appears to be a small amount of active extravasation inferiorly.There appears to be contrast on both sides of the vein wall consistent with pseudoaneurysm and/or dissection.The last venogram obtained 2 weeks after the filter retrieval demonstrates occlusion of the ivc at approximately the same level of previous injury.The visualized central portion of the iliac veins also appear to be occluded.Per clinical assessment, one likely explanation for retrieval difficulties is that the filter may have been pulled into the retrieval sheath as opposed to the retrieval sheath being advanced over the collapse ivc filter.The cause of the mild filter tilt and minimal penetration as seen on the venogram is indeterminate.According to the ifu, filter retrieval is sometimes complicated by extended dwell time due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The ifu recommends, considering filter retrieval once protection from pe is no longer necessary.Furthermore, 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.It also states that excessive force should not be utilized for filter retrieval.No evidence to suggest the product was not manufactured according to specifications.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.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8415696
• MDR Text Key: 138660474
• Report Number: 3002808486-2019-00298
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR