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 Abdominal Pain (1685); Blood Loss (2597); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pt information: unknown as information was not provided.Brand name: unknown as lot# is unknown lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Implant date: unknown as information was not provided.Pma 510(k): similar to device under 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfg date: unknown as lot# is unknown.(b)(4).Summary of investigational findings: the images from the article do show filter leg perforating into the duodenum.However, migration cannot be confirmed based on the images.But filter tilt and ivc perforation appear to have been equated with migration.The root cause of the perforation is unknown.A reference is made to the instructions for use: in potential adverse events are mentioned: damage to the vena cava.Pulmonary embolism.Filter embolization.Vena cava perforation.Vena cava occlusion or thrombosis.Hemorrhage.Hematoma at vascular access site.Infection at vascular access site.Death.Nothing indicate that product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to journal article: a (b)(6) year old female presented to the emergency department (ed) with severe epigastric pain and bleeding into her colostomy bag.One year prior to presentation, she developed a pulmonary embolism and left leg dvt concurrently with life-threatening aneurysmal bleeding from her intercostal and common hepatic arteries.At the time, a retrievable ivc filter (cook celect) was inserted.Anticoagulation was not initiated due to her history of severe aneurysmal bleeding.She was lost to follow-up.On arrival to ed, she was hypotensive with a systolic blood pressure of 65 mmhg.Her blood tests revealed severe thrombocytopenia at 40 x 10 /l (reference range: 150-450 x 10 /l) and a haemoglobin of 93 g/l (reference range: 120- 150 g/l).She was fluid resuscitated and was transfused packed red blood cells and platelets.An abdominal computed tomography (ct) scan revealed ivc filter limb extension into the duodenum.Urgent esophagogastroduodenoscopy (egd) revealed that the filter limb had perforated the duodenum at d2.After stabilisation, she was taken for a laparotomy with removal of ivc filter and repair of ivc and duodenal defect.Intraoperatively, it was noted that she had extremely friable tissues due to her polyarteritis nodosa and long term steroid use with hemostasis being difficult to achieve.Multiple attempts to retrieve the ivc filter via the right internal jugular route were made without success.An endovascular balloon catheter was inserted into the infrarenal ivc via a percutaneous femoral puncture to control bleeding.It was noted at this stage that this balloon had caused a split in her infrarenal ivc with periods of severe hypotension and an episode of ventricular fibrillation that responded to defibrillation.Hemostasis was achieved with a combination of external and endovascular balloon pressure, ivc ligation, direct suture repair as well as multiple blood products.The planned removal of ivc filter was abandoned.Her abdomen was packed due to the difficult haemostasis and she was taken to the intensive care unit.A re-look laparotomy the following day revealed no further bleeding; the packs were removed and her abdomen was closed.Her post-operative recovery was characterised by multiple platelet transfusions (>20 units).A surveillance egd revealed that the ivc filter limb had not moved any further into the duodenum.She recovered and was weaned off her steroids under the guidance of the immunology team to optimise any further surgery.She was discharged 3 months after her initial presentation.Considering previous attempts to remove the ivc in its entirety had been unsuccessful, it was decided that the most appropriate solution was to remove the ivc limbs that had perforated her duodenum whilst leaving the filter portion within the ivc in situ.She was readmitted for the excision of ivc filter limbs 4 months after her initial presentation with pre-operative platelet transfusion to reduce her risk of operative bleeding.The ivc filter limbs were excised as flush to the ivc as possible and the duodenal defect was repaired.Her post-operative course was unremarkable and she was discharged on post-operative day 10.Repeat imaging 2 months post operation revealed no evidence of further ivc filter migration.Her thrombocytopenia stabilised to the point where she has been platelet transfusion free since the operation.She is to remain on long term immunology and surgical follow-up surveillance.Patient outcome: the patient required the following additional procedures due to this event: blood transfusions, multiple attempts to retrieve the ivc filter.Excision of filter limbs.Adverse effects to the patient were reported as: epigastric pain and bleeding into her colostomy bag.Filter limb had perforated the duodenum.

• 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: 5899280
• MDR Text Key: 52833275
• Report Number: 3002808486-2016-00980
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention