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

Catalog Number UNKNOWN

Device Problem Separation Failure (2547)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since catalog# is unknown the 510(k) could be either (b)(6).Investigation is still in progress.

Event Description

Description according to article: the patient presented to our institution 20 weeks' post placement for filter retrieval.Pre-retrieval ct demonstrated filter strut penetration.Venous access was acquired through the right internal jugular vein, and an 11-fr sheath was advanced into the ivc.Caval venography confirmed filter strut penetration into the ivc wall and an 8 degrees filter tilt.A 15-mm snare-catheter combination was used to snare the hook of the filter.However, multiple attempts to envelop the snared filter struts into the sheath were unsuccessful with failure of disengagement of the distal portion of the filter struts from the wall of the ivc.The snare sheath of the in situ 15-mm snare was then removed.A 25-mm snare was coaxially introduced over the 15-mm snare, followed by the snare catheter.Patient outcome: this snare-sheath combination was advanced distally over the filter struts, which were then successfully dislodged from the ivc wall and enclosed in the sheath.

Manufacturer Narrative

(b)(4).Catalog #: unknown but preliminary investigation of imaging showed a cook günther tulip filter and not a g2 filter referred to in description of event.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k090140, k112119 or 121057.Unknown as lot # is unknown.Summary of investigational findings: this complaint is based on the case with a (b)(6) male.The image review demonstrated primary filter leg perforation of at least two legs.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.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.Rpn and lot# are unknown, but there is 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 according to article: the patient presented to our institution 20 weeks¿ post-placement for filter retrieval.Pre-retrieval ct demonstrated filter strut penetration.Venous access was acquired through the right internal jugular vein, and an 11-fr sheath was advanced into the ivc.Caval venography confirmed filter strut penetration into the ivc wall and an 8° filter tilt.A 15-mm snare-catheter combination was used to snare the hook of the filter.However, multiple attempts to envelop the snared filter struts into the sheath were unsuccessful with failure of disengagement of the distal portion of the filter struts from the wall of the ivc.The snare sheath of the in situ 15-mm snare was then removed.A 25-mm snare was coaxially introduced over the 15-mm snare, followed by the snare catheter.Patient outcome: this snare-sheath combination was advanced distally over the filter struts, which were then successfully dislodged from the ivc wall and enclosed in the sheath.

• 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: 5569042
• MDR Text Key: 43180053
• Report Number: 3002808486-2016-00178
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• 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?: Yes
• Date Manufacturer Received: 03/18/2016
• 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
• Patient Outcome(s): Other