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

Catalog Number UNKNOWN

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Pma/510(k): k172557.Investigation is still in progress.

Event Description

Description of event according to initial reporter: an unknown filter, either a g52916 igtcfs-65-1-jug-tulip or g52917 igtcfs-65-1-fem-tulip.Also used in the procedure was a g13287 gtrs-200-rb (lot # 10012453) but per the initial reporter, neither they nor the user facility believe the retrieval set contributed to the failure.((b)(4) reference # 1820334-2021-01855) implant took place at another user facility and the outpatient location was doing the retrieval procedure.During retrieval (patient no longer needed filter), the user did an initial venogram.Looking for tilt and blood clots, etc.Difficult to see any issue with the filter under fluoro, so they proceeded with the case.They realized after retrieval that part of the secondary strut was bent "upwards." it wasn't attached to the primary strut.When they snared the filter, they snared that piece as well as the filter and that detached piece sheared the inside of the retrieval sheath.User could tell under fluoro that the sheath was sheared, so they had to remove that sheath and use another 10fr sheath.Upon changing out the sheath, procedure proceeded as normal.Access was not lost during the sheath change.All pieces of the product were successfully retrieved from the patient.Additional information received on 20jul2021: it appears on the initial image taken during the retrieval that the secondary strut was no longer attached to the primary strut.We are uncertain if it was technically fractured at this point, it appears to be flipped upwards.When trying to retrieve the filter, the snare was originally stuck on the secondary strut.This secondary strut was not well visualized on live fluoro, but we could tell the snare was around this piece and we couldnt release it.When the snare was advanced around the hook of the filter, we tried to advance the sheath over the filter.This action caused the sheath tear, the secondary strut had significant friction against the inner sheath and this made the sheath deformed.The physician did not feel comfortable removing the filter with the visibly damaged sheath.A new 10fr sheath was opened and exchanged, the filter hook was snared and the filter plus damaged secondary strut were removed in one attempt successfully.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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: discovered during retrieval that a part of a secondary filter leg bent ¿upwards¿ ((b)(4)).The piece and the filter were both snared, but sheared the inside of the retrieval sheath ((b)(4)).The sheath was removed and the piece as well as the filter were successfully retrieved after changing the sheath.No product was returned for investigation, but three fluoroscopic images and two photographs were submitted for review.The complaint report does not include the placement images.The reported initial images do demonstrate malposition of a secondary strut which appears to extend cranially above the level of the ivc filter hook.The fluoroscopic images, it is difficult to determine if this secondary strut is fractured and malpositioned in this region or if it is folded back on itself.Given the configuration the junction of the secondary arm with the neck of the ivc filter may have fractured resulting in the fragment wrapped around the primary filter leg to be displaced cranially.The complaint report describes capturing the ivc filter with a gunther tulip retrieval set.Reportedly, the snare also included the fractured secondary filter leg.No images of this configuration were submitted for review.However, while attempting to retract the filter into the retrieval sheath, the distal tip of the sheath was lacerated longitudinally requiring the sheath to be changed out.The description surrounding this event is not very precise, but it can be postulated that while attempting to retract the filter entirely within the black stiffer component of the retrieval set, given the malpositioned secondary leg, either the primary filter foot or a portion of the fractured secondary leg extended outside of the tip of the black component of the sheath.While attempting to retract device within the outer blue component of the sheath, this resulted in the rent/laceration.Ideally, the filter should be entirely collapsed within the inner portion of the sheath and retracted as a unit through the outer portion of the blue sheath with little to no portion of the filter coming in contact with the blue sheath.This latter complication involving the outer/blue sheath is a direct result of the first complication which is fracture and displacement of the secondary filter arm.It is uncertain if patient was instrumented in any capacity that may have contributed to the fracture of the secondary filter arm, but fortunately, the patient experienced no harm, and the device was removed in its entirety.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.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 ; 56868686
• MDR Report Key: 12279057
• MDR Text Key: 265214241
• Report Number: 3002808486-2021-01675
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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: 08/05/2021
• Is this an Adverse Event Report?: No
• 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
• 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 Age: 59 YR
• Patient Sex: Male