MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

Device Problem Difficult to Remove (1528)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Description of event according to initial reporter: a (b)(6) male patient underwent an ivc filter retrieval for a cook celect platinum vena cava filter that was placed (b)(6) 2021.The physician and the district manager were unable to retrieve the filter in the ivc at the time of the case.The patient had his filter placed in (b)(6) 2021 due to pe¿s and large dvt in femoral vein.Patient was scheduled back in (b)(6) 2021 to have filter removed but was unable to due to clot still present in filter.Yesterday, the district manager and physician were clear of clots in the filter ¿ went to remove and had trouble.The physician was able to snare the hook and collapse almost all of the filter except the legs.The physician was pushing down on sheath very hard to try to collapse the legs, but felt that it was going to rip the ivc.He decided to abort the procedure due to concerns with tearing the ivc by removing filter with any more force.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).Catalog# is unknown but referred to as celect filter.Occupation: lead tech.Investigation is still in progress.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.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

Additional information received 11jan2022: product lot# and product identifier.We were unable to retrieve the filter in the ivc at the time of the case.The patient had his filter placed in february 2021 due to pe¿s and large dvt in femoral vein.Patient was scheduled back in october 2021 to have filter removed but was unable to due to clot still present in filter.Rescheduled for december 2021 we were clear of clots in the filter ¿ went to remove and had trouble.Procedural approach: filter removal via jug.No anatomical conditions and/or abnormalities that could have had an impact on the difficulties encountered.The filter hook was not embedded in the caval wall and there were not observed any ingrowth the filter orientation relatively straight before retrieval procedure.Retrieval product(s) used during the procedure: clover snare g53008 lot 14232565 there is suspicion that the barb on any filter leg was embedded in the caval wall.No filter penetrate / perforate of the caval wall during retrieval procedure.The physician was able to snare the hook and collapse almost all of the filter except the legs.He said ¿i was pushing down on sheath very hard to try to collapse the legs, i felt that i was going to rip the ivc.¿ he decided to abort the procedure due to concerns with tearing the ivc by removing filter with any more force.No plans for additional treatment or patient follow up.Patient is 70 years old.Md doesn't feel the need to remove because of his age and difficulty of retrieval.

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: a celect-pt filter that was placed in (b)(6) 2021 was attempted to be removed on (b)(6) 2021.The physician was able to snare the hook and collapse almost all of the filter except the legs.Because of concerns of tearing the ivc if more force should be used to remove the filter, the physician decided to abort the procedure.Due to patient age and difficulty of retrieval the filter the physician doesn¿t feel the need to remove the filter.Three fluoroscopic images from attempted ivc filter retrieval, along with a video of a venogram, and the complaint report, were submitted for review.Per imaging reviewer´s findings: the video submitted for review demonstrates a measuring pigtail catheter positioned caudal to a celect platinum ivc filter positioned in the infrarenal ivc.There is no evidence of significant thrombotic burden within the ivc filter.There is no evidence of penetration on this single projection.The filter feet appear to terminate at the wall of the ivc.There is no evidence of significant tilt measuring only a few degrees towards the right relative to the segment of the ivc filter in which it was inserted.Several fluoroscopic images demonstrate a gunther tulip retrieval set positioned just cranial to the ivc filter with the loop snare positioned around the hook of the celect platinum ivc filter.There is no evidence of filter fracture.The maximal distance between the primary filter legs measures approximately 18 mm.The subsequent image demonstrates the filter completely collapsed in the outer sheath of the gunther tulip retrieval set.The sheath is advanced down to the level of the filter feet, but the filter feet have not fully retracted within the sheath itself.Of note, there only appears to be the outer sheath present and not the inner sheath of the retrieval set.The next image demonstrates the celect platinum ivc filter in the original configuration without significant change in angulation or appearance of the filter.Per imaging reviewer´s impressions: per the complaint report, the celect platinum ivc filter had been in place for approximately 10 months.Initial retrieval attempt occurred two months prior to this attempt and was aborted due to thrombus within the ivc filter.On the venogram submitted for review today, there is no evidence of significant thrombus in the ivc filter and retrieval attempt was pursued.As is evident on the submitted images, the hook of the ivc filter was easily captured by the gunther tulip retrieval set loop snare, but per the complaint report the legs would not completely retract into the retrieval sheath."i was pushing down on the sheath very hard to try to collapse the legs, i felt that i was going to rip the ivc." is documented by the physician as to why the retrieval attempt was aborted.On the submitted image, it does appear the ivc filter was completely collapsed within the retrieval sheath, just the outer sheath of the gunther tulip retrieval set.It does not appear the inner portion of the sheath is present and may account for some of the difficulty in retrieving filter.As is stated in the ifu, the inner portion of the retrieval sheath should be advanced to the level of the ivc filter feet allowing it to free the feet from the ivc wall.This inner sheath is much thicker material than the outer sheath and much more rigid, enabling greater force to be applied to the filter feet, facilitating freeing them from the ivc wall.Once the filter is collapsed and freed from the ivc wall, the outer sheath is to be advanced over the entire collapsed system.On this single image submitted for review of the collapsed ivc filter, it is not apparent that the inner sheath was being used to its full capacity.Despite this, ivc filters can occasionally be very stubborn and difficult to detach from the ivc wall.Often with longer dwell times, it takes significant force in order to free the filter feet from the wall of the ivc.If this is not an experienced operator, this degree of force may make them feel uncomfortable, and may be attributed to the situation described.Furthermore, if true concern for ivc injury was present, a safety wire could have been inserted enabling any potential tear in the ivc to be addressed with balloon tamponade and/or endovascular repair if necessary.There are innumerable case reports describing ancillary devices such as bronchial forceps, laser sheath and cutting sheath techniques to free ivc filters feet from the wall of the ivc in identical circumstances, none of which were attempted or discussed in this case.In this case, the ivc filter still appears to be nicely centered within the ivc, and by using one of these ancillary devices, one should be successful in removing this filter without significant risk of injury.Despite the challenges described, this filter still appears readily accessible and should be removed if it is no longer clinically indicated, if not by the reporting physician, by one with more experience and potentially in a center that specializes more complex retrievals.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.According to instruction for use potential adverse events that may occur include, but are not limited to, the following: retrieval failure there are adequate controls in place to ensure the device was manufactured to specifications.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Based on the provided information and imaging review an exact cause for this event cannot be established.However, the filter still appears readily accessible and should be removed if it is no longer clinically indicated.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: COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• 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: 13116686
• MDR Text Key: 283670420
• Report Number: 3002808486-2021-02050
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)231019(10)E4031443
• 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,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E4031443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• 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: 70 YR
• Patient Sex: Male