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

Catalog Number UNKNOWN

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 08/30/2021

Event Type  Injury  

Event Description

Description of event according to initial reporter: primary strut came off and was retrieved.This filter was implanted in 2008 at another hospital.The patient was experiencing intermittent abdominal pain when eating.This is what preceded and initiated the filter retrieval.Additional information received 03sep2021: the filter/filter leg was retrieved with 20 fr sheath, 16th fr sheath, and lymol forceps.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

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: approx.13 years after filter placement the patient experienced pain when eating.The filter fractured during retrieval with forceps, but filter as well as fractured filter leg were removed without reported harm to the patient.The filter was not returned, but multiple fluoroscopic and venographic images from the filter retrieval were submitted for review.Per the complaint report, the ivc filter had a dwell time of approximately 13 years at time of retrieval.The patient describes intermittent abdominal pain, which is uncertain if this pain is related to the ivc filter and the complaint report does not state if the pain improved after the filter was retrieved.The initial images demonstrate significant penetration involving at least one of the laterally directed primary filter legs of a suprarenal celect ivc filter.Although difficult to appreciate the degree of anterior posterior tilt present, there is likely a significant tilt present given the discrepancy in the primary filter feet locations on this projection.The ivc filter was successfully retrieved using advanced techniques and an endobronchial forceps, although the amount of force required to retrieve the filter was not discussed in the complaint report.When using an endobronchial forceps, it is common to use significant force to free the filter from the ivc wall and to retrieve it.During the retrieval, a fracture involving one of the primary filter legs did occur and the primary filter leg was not initially retrieved with the filter.Fortunately, the primary filter leg did not embolize indicating it was likely still penetrating through the wall of the ivc preventing its migration.The filter leg was successfully retrieved at the conclusion of the procedure.The fracture appeared to develop at the junction of the primary filter leg and the neck of the ivc filter suggesting that it likely occurred due to metal fatigue from abnormal stresses on that primary filter leg.These abnormal stresses were presumably related to the penetration of the primary filter leg which altered the stresses placed on the junction of the primary filter leg at the filter neck, which then was prone to fracture with manipulation during retrieval.Without the placement images, it is difficult to determine if the filter configuration has changed with time, potentially as a byproduct of the developing penetrations, or if the filter configuration contributed to the development of penetrations.This question cannot be answered with any certainty.In conclusion, the fracture filter fragment did not embolize centrally and was successfully retrieved without any harm to the patient.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.

• 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: 12526036
• MDR Text Key: 273124337
• Report Number: 3005580113-2021-00109
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2021,01/18/2022

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2021
• Distributor Facility Aware Date: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/18/2022
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female