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

Catalog Number UNKNOWN

Device Problems Retraction Problem (1536); Structural Problem (2506)

Patient Problems Great Vessel Perforation (2152); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): unknown rpn.Investigation is still in progress.

Event Description

Description of event according to the initial reporter: a (b)(6)-old woman developed acute dvt during pregnancy and underwent r-ivcf (günther-tulip) implantation.A few months after delivery, she presented with bilateral leg edema.Although ct showed thrombotic occlusion of the filter with bilateral iliac vein thrombotic occlusions, filter retrieval failed and she had been followed up with anticoagulation.She was referred to our hospital for filter retrieval after 2.5 years.The filter was successfully removed by combining all devices and approaches.However, a tiny fractured strut was left in the caval wall, which we failed to pick up.Patient outcome: the patient had an uneventful course without symptoms related to residual fractured strut.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).D4) catalog# is unknown but referred to as cook gunther tulip filter.Summary of investigational findings: the filter was placed during pregnancy and after delivery the patient presented with bilateral leg edema and ct showed thrombotic occlusion of the filter with bilateral iliac vein thrombotic occlusions, why filter retrieval was not attempted, but patient followed up with anticoagulation ((b)(4)).After 2.5 years the filter was successfully retrieved ¿by combining all devices and approaches¿, but a fractured strut remained in the patient.The patient had an uneventful course without symptoms related to residual fractured leg.Based on the information provided in the literature only it would be inappropriate to speculate at what may or may not have caused a filter leg to fracture during retrieval of the filter.However, since the filter was retrieved after 2.5 years ¿by combining all devices and approaches¿ reference is made to the instructions for use specifying that the filter was designed to be retrieved with the günther vena cava filter retrieval set or with the cloversnare.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.

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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 12914978
• MDR Text Key: 281572235
• Report Number: 3002808486-2021-01983
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• 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): Other
• Patient Age: 30 YR
• Patient Sex: Female