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

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Catalog# is unknown but referred to as a cook celect filter.Investigation is still in progress.

Event Description

Description of event according to twitter case report: extensive filter-related iliocaval thrombosis.Cook celect with an 11 year dwell time.Thrombectomy, filter out, and venous reconstruction.Patient had rapid improvement in symptoms.Complex ivc filter retrieval and comprehensive venous care.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigation findings: a case of extensive filter iliocaval thrombosis was seen after 11-year dwell time of a celect filter.It was reported that the procedure included a complex filter retrieval, thrombectomy and venous reconstruction.After the procedure the patient had rapid improvements in symptoms.Three images were provided for the investigation and an imaging review were performed.Per imaging reviewer´s findings: ¿first image is a coronal reformat from a ct scan of the abdomen and pelvis with iv contrast.This demonstrates a celect ivc filter in the infrarenal ivc.Relative to the centerline of the ivc, there is approximately 18° of leftward tilt present.There is extensive thrombus seen below the level of the ivc filter, as well as cranial to the ivc filter extending to the level of the left renal vein.The thrombus above the level of the ivc filter measures approximately 5.5 cm in length and 18 mm in diameter.The next image demonstrates the capture of the celect ivc filter utilizing an endobronchial forceps from a jugular approach through a 16-french sheath.The last image demonstrates a venogram status post endovascular reconstruction using stents extending from the bilateral common iliac veins to the ivc.The venogram demonstrates in-line flow without evidence of residual significant thrombosis or flow limiting stenosis.¿ per imaging reviewer´s impression: ¿the complaint report does describe this scenario as "filter related iliocaval thrombosis".The image submitted for review does demonstrate extensive iliocaval thrombosis located both cranial and caudal to the ivc filter.No clinical information regarding the patient's indication for ivc filter was included in the complaint report, nor any potential contributing causes to the development of this thrombotic event.It is well described in the literature that the presence of an ivc filter does increase the risk of lower extremity and iliocaval deep vein thrombosis.¿ 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.According to the instruction for use potential adverse events includes vena cava occlusion or thrombosis there are adequate controls in place to ensure that this type of filter is manufactured to specifications.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Based on the provided information an exact cause for this event cannot be established.However, thrombosis is a known risk in relation to filter implant.Cook will reopen the investigation if further information or images is received.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.

• 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: 11184236
• MDR Text Key: 230488310
• Report Number: 3002808486-2021-00027
• 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: other
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• 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
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention