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

Catalog Number UNKNOWN

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as the lot # is unknown.Since catalog# is unknown the 510(k) could be either k061815, or k073374, or k090140, or k112119, or k121629, or k121057.Mfr date unknown as lot # is unknown.Investigation is still i progress.

Event Description

Description of event according to complainant: the filter had fractured secondary strut.The fractured secondary strut was retrieved first via the loop snare technique.Next, the physician attempted to retrieve the filter with the clover snare; however, it was unsuccessful.At this point, the physician reverted back to the loop snare technique and successfully retrieved the filter.Upon final retrieval a venogram was shot with zero extravasation.On 01jun2016/sdr: additional information received: this celect ivc filter was placed about a year ago in (b)(6).A specific hospital could not be provided at this time.The fractured portion got bent during the extraction process.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturer ref#p) since catalog# is unknown the 510(k) could be either k061815, or k073374, or k090140, or k112119, or k121057.(b)(4).Summary of investigational findings: investigation is based on event description and returned product.Investigation of the returned product confirms that the filter had a fractured secondary leg.Sem images shows that it is a stress fracture.Due to the limited information provided, it is not possible to determine the root cause of the fractured secondary filter-leg.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.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.There is found 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.

Event Description

Description of event according to initial reporter: the filter had fractured secondary strut.The fractured secondary strut was retrieved first via the loop snare technigure.Next, the physician attempted to retrieve the filter with the clover snare; however it was unsuccessful.At this point, the physician reverted back to the loop snare technigue and successfully retrieved the filter.Upon final retrieval a venogram was shot with zero extravasation.On 01jun2016 add info: this celect ivc filter was placed about a year ago.The fractured portion got bent during the extraction process.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5722117
• MDR Text Key: 48421199
• Report Number: 3002808486-2016-00531
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 39 DA