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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Great Vessel Perforation (2152); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k) k211875.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a cardiologist indicated one of his partners had got confused while placing a celect platinum filter and inadvertently deployed the filter just below the heart.The physician and the dm spoke about the risk of migration (as the physician was inquiring).The physician did not have a measurement of how close to the heart.However, the physician provided a video / venogram and the filter is extremely close to the heart.It appears the hook may be outside of the cava wall.The physician is weighing the risks of performing a retrieval or leaving it implanted." the physician is leaning towards leaving the filter in place.This filter was not placed per indication (info provided by dm).

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that the physician got confused and deployed the celect-pt filter inadvertently just below the heart.The physician did not have a measurement of how close the filter was to the heart.However, the physician provided a video / venogram and the filter is extremely close to the heart.It appears the hook may be outside of the cava wall.The physician is weighing the risks of performing a retrieval or leaving it implanted.It is noted that the physician is leaning towards leaving the filter in place.A video of a venogram was provided for imaging review.Per imaging reviewer´s findings: un-subtracted video of a venogram following deployment of a celect platinum ivc filter in the suprarenal location demonstrates a celect platinum ivc filter with 12° of rightward tilt.The hook of the ivc filter extends approximately 3 mm outside of the wall of the ivc suggesting there is penetration present.The maximal distance between the primary filter feet measures approximately 22 mm.The filter hook terminates at least two centimeters below the cavoatrial junction, and the filter feet insert on the wall of the ivc just cranial to the inflow of the renal veins.Per imaging reviewer´s impressions: per the complaint report, the physician "inadvertently deployed the filter just below the heart." the video submitted for review demonstrates a celect platinum ivc filter in the suprarenal location with 12° of rightward tilt.The hook of the ivc filter does appear to extend greater than 3 mm outside of the wall contrast and likely is penetrated through the wall of the ivc.There is significant movement of the filter and ivc in this region with respiration and cardiac cycles, which is considered normal and has likely contributed to the perforation of the hook through the wall of the ivc.It is uncertain if this video is from time of placement, or from a follow up study.If this video is not from the placement procedure, without the initial placement images, it is impossible to determine if the tilt was part of the initial mal-deployment, or if the filter has tilted over time.In addition, the physician "accidentally deployed" the filter in the suprarenal location.Despite the tilt, and given the development of penetration, the ivc filter should be removed and repositioned in a more appropriate location.If the operator is not comfortable given the complexity of the filter location, the filter should be referred to an institution that specializes in complex retrievals.Leaving the filter in this location will only result and worsening penetration, likely tilt, and potentially filter fracture over time.The dynamic forces of the ivc in this location with respiration and cardiac cycle will contribute to these potential complications.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 perform diagnostic imaging to verify position of the introducer sheath tip (or radiopaque marker) approximately 5 cm caudal to the lowest renal vein.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Based on the provided information and imaging review it is confirmed that the filter was released in an undesirable position.It is noted that the physician is leaning towards leaving the filter in place, but it is recommended that the filter should be removed.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: 14336293
• MDR Text Key: 291207499
• Report Number: 3002808486-2022-00297
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2022
• 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): Life Threatening; Required Intervention