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

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Internal Organ Perforation (1987); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Article: case report on the non-operative management of a retrievable inferior vena cava filter perforating the duodenum.Fernandez-moure et al, 2017.Catalog# is unknown but referred to as cook celect filter.Name and address for importer site:(b)(4).Since catalog# is unknown 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).Investigation is still in progress.

Event Description

Description of event according to article: "one year prior, the patient was diagnosed with glioblastoma multiform, from which he underwent a craniotomy with near-total resection of the mass.He subsequently developed a dvt during the course of his hospitalization thus underwent placement of a cook celect pt filter because of his significant bleeding risk.The patient was in his usual state of health when he presented to the er with melena and syncope.Two days prior to the presentation at the er the patient reported having a large-volume maroon-colored bloody bowel movement followed by a moderate volume of bright red blood, which eventually stopped after 2 hours.The following morning the patient has another bowel movement of bright red blood that soaked his bed sheets.The patient was taken to the hospital by his family where he was found to be in hemorrhagic shock with hemoglobin of 4.6 g/dl and a systolic blood pressure of 60 mmhg.After resuscitation with crystalloid intravenous fluids and 4 units of packed red blood cells, the patient was transferred to receive higher level of care.Once the patient was stabilized a ct scan was ordered.The ct scan revealed an infrarenal ivc filter with tines extending beyond the wall of the ivc and into the lumen of the distal second and proximal third portion of the duodenum.The team elected endovascular removal of the filter rather than surgery.The filter was successfully retrieved through an endovascular approach and the patient was monitored for bleeding.The patient resumed an oral diet and was subsequently discharged home." patient outcome: the complainant reported that the product caused or contributed to large volume of melena and complaining of syncope.

Manufacturer Narrative

Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: investigation is based on article and imaging review.The celect filter was placed in ivc without significant tilt.One year after filter placement, the patient presented to the er with hemorrhagic shock due to persistent gi bleed.Ctscan performed at this time demonstrated multiple grade 3 interactions with the ivc wall.At least one primary filter leg perforated the duodenum wall and extents into the lumen.There was no active bleeding or mucosal signs to suggest recent bleeding, but the perforation was the presumed cause of the gi bleed.Follow-up ct and venogram imaging from time of retrieval confirmed the multi-leg perforation.The location where the filter legs perforated through the ivc wall was at the apex of curvature of ivc.This bend in the ivc was likely caused by the ectasia of the aorta seen on ct scan pushing on the ivc in a similar configuration.This bend in the ivc likely altered the forces placed on the filter feet, the same as a significant tilt would alter the forces on individual legs and facilitate the development of perforation.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: 6892979
• MDR Text Key: 87296963
• Report Number: 3002808486-2017-01872
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• 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?: Yes
• Distributor Facility Aware Date: 09/05/2017
• Date Manufacturer Received: 11/13/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 67 YR