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

Catalog Number UNKNOWN

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.(b)(4).Since catalog # is unknown the 510(k) could be either k090140, k112119 or k121057.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "patient requested through his referring physician to have a gunther tulip ivc filter retrieved.The filter was placed at another facility three years prior according to the radiologist.Using a cook gtrs-200-rb attempt was made to retrieve.Hook was engaged and system drawn over the filter.Resistance occurred as the sheath approached the feet of the filter.Further manipulation resulted in the filter being twisted.The system was removed and a second attempt was made with a 16f cook sheath.This was also unsuccessful.Post attempt, a venogram was performed and the ivc was seen to be restricted.The physician made a request to transfer the patient to another facility for follow-up." per the rep: ivc was collapsed and blood flow was obstructed above the ivc.The filter was collapsed down to a level 1 or 2 cm above the feet.The four anchoring feet of the filter would not separate from the caval wall.In trying to free the feet from the caval wall, the physician attempted a twisting motion of the sheath resulting in the filter twisting in the vena cava but failing to release the anchoring feet.Please note: the patient was transferred to another facility where the filter was removed using extraordinary endovascular techniques.The physician reports the patient is doing well and has been discharged and sent home.Patient outcome: the patient is doing well and has been discharged and sent home.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: this complaint relates to (b)(4) and the investigation is based on event description and image review.On the single fluoroscopic image provided, a partially collapsed tulip filter is still engaged with the retrieval snare device.The proximal two thirds of the ivc filter are completely collapsed and the legs appear to flare at the junction of the secondary legs and primary filter legs.Although not confirmed on this image, this is likely the point at which the primary filter legs perforated through the wall of the ivc and there is significant in-growth of the endothelium at the junction of the primary and secondary legs.This is the typical location in which a retrieving physician trying to remove a tulip filter, with a long dwell time, will run into difficulty due to endothelial proliferation and ingrowth at this portion of the filter.Per the complaint report, when the retrieving physician encountered resistance at this level, attempts to remove the ivc filter including ¿a twisting motion of the sheath¿ resulted in the filter to twist/entangle in itself, inhibiting the self-expanding nature of the filter.Discussed, although no images were submitted, a venogram demonstrated the ivc itself was restricted at this level.The patient was transferred to another facility where the filter was eventually retrieved endovascularly with "extraordinary endovascular techniques".There have been many studies demonstrating the safety of retrieving the tulip filter, but it is well documented that the longer the dwell time, the more difficult the retrieval can become due to a number of factors including endothelial ingrowth.Typically, if a filter is unable to be retrieved due to this ingrowth, it does not retain the compressed/collapsed appearance seen during the actual retrieval.On the rare occasion when this has occurred, follow-up balloon angioplasty usually resolves this scenario.This collapsed/restricted appearance of the ivc was likely accentuated due to the twisting motion the physician applied during the attempted retrieval.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.The cause of the presumed perforation, at this point, is indeterminate, but vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook medical will continue to monitor for similar events.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 7023939
• MDR Text Key: 91894594
• Report Number: 3002808486-2017-02217
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/25/2017
• Date Manufacturer Received: 12/08/2017
• 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