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

Catalog Number UNKNOWN

Device Problems Failure to Capture (1081); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two unsuccessful retrieval attempt on (b)(6) 2014.Catalog #: unknown cook celect filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date unknown as lot # is unknown.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the patient had a cook celect ivc filter implanted on (b)(6) 2014 for a laminectomy procedure to treat his sciatica.His physician had initially intended to remove the filter within 10 days after the laminectomy procedure.His first unsuccessful retrieval attempt occurred in (b)(6) 2014.His second unsuccessful retrieval attempt occurred in (b)(6) 2014.The patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems.His legs are swollen, tight and full of pressure.He has had to use a walker since his filter placement procedure.He believes that the cook celect ivc filter may be the cause of his problems.He is having another laminectomy procedure soon that could improve some of his symptoms but he has been told by his surgeon that the laminectomy will not help his leg problems.The patient has recently had an ultrasound that showed that the filter is in his abdomen.A different physician will soon be attempting to confirm this with x-ray.The patient is very worried that his filter has moved or could move in a dangerous way.Patient outcome: the patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems.His legs are swollen, tight and full of pressure.He has had to use a walker since his filter placement procedure.

Manufacturer Narrative

(b)(4).Date of event: two unsuccessful retrieval attempt on (b)(6) 2014.Catalog#: unknown cook celect filter.Since catalog# is unknown the 510(k) could be similar to either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Summary of investigational findings: investigation is solely based on event description since no imaging is provided and no product is returned.Additional information states, that the filter has not migrated to pt's abdomen, but it is tilted and has not been retrievable in two attempts.However, without a medical report/imaging it would be inappropriate to speculate on what may have led to the failure mode.Nor would it be appropriate to comment on the patient's medical condition following operation and filter placement.The complaint will be reopened, if imaging or additional information is provided.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature.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.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 patient had a cook celect ivc filter implanted on (b)(6) 2014 for a laminectomy procedure to treat his sciatica.His physician had initially intended to remove the filter within 10 days after the laminectomy procedure.His first unsuccessful retrieval attempt occurred in (b)(6) of 2014.His second unsuccessful retrieval attempt occurred in (b)(6) of 2014.The patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems.His legs are swollen, tight and full of pressure.He has had to use a walker since his filter placement procedure.He believes that the cook celect ivc filter may be the cause of his problems.He is having another laminectomy procedure soon that could improve some of his symptoms but he has been told by his surgeon that the laminectomy will not help his leg problems.The patient has recently had an ultrasound that showed that the filter is in his abdomen.A different physician will soon be attempting to confirm this with x-ray.The patient is very worried that his filter has moved or could move in a dangerous way.According to the physician "the filter has not migrated to the patient's abdomen.It is tilted and has not be retrievable in two attempts" patient outcome: the patient is now experiencing circulation problems, lower body immobility and bladder and bowel problems.His legs are swollen, tight and full of pressure.He has had to use a walker since his filter placement procedure.

• 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: 5982373
• MDR Text Key: 55790097
• Report Number: 3002808486-2016-01167
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• 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
• Date Manufacturer Received: 09/14/2016
• 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