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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event must be from prior 2008 since the article is published in 2007.Catalog#: unknown but referred to as a cook celect filter.Investigation is still in progress.

Event Description

Description of event according to article: before filter placement, a radiograph of the ivc was obtained that showed a patent vena cava measuring 19 mm in diameter.The filter deployment was uneventful, and the postprocedural radiograph confirmed satisfactory filter positioning and opening at the level of the l2 vertebral body.Nine days after filter placement and discharge, the patient presented to the hematology clinic with severe back pain, which had gradually worsened.A provisional diagnosis of retroperitoneal hemorrhage was made, and computed tomography (ct) of the abdomen and pelvis was performed, which showed all four primary struts of the filter well beyond the confines of ivc, consistent with transmural ivc penetration.The most displaced of these struts was the left anterolateral strut, which extended into the uncinate process of the pancreas.The remaining three struts were located in the retroperitoneal fat posterior to the aorta, right psoas muscle, and pancreaticoduodenal groove, respectively.Despite the extracaval location of the struts, no retroperitoneal hemorrhage, inflammation, or stranding was present.There was also no imaging evidence of pancreatitis.No other cause for the patient's back pain was demonstrated.In view of the ct findings it was decided to retrieve the filter.Before retrieval, a radiograph of the ivc was obtained, which showed an approximate 3-cm caudal migration of the filter from its original position at the level of the l2 vertebral body to the l3 level, resulting in a more horizontal orientation of the primary struts.A small amount of thrombus was present within the filter cone.The filter was snared, and other than significant pain during removal of the filter, there were no local or pulmonary complications.Through this same sheath, an optease retrievable filter was placed in the infrarenal ivc at approximately the same from the department of diagnostic imaging, the location, as verified on an ivc radiograph.Patient outcome: the patient's back pain improved, and she was discharged the following day and has since remained symptom-free.

Manufacturer Narrative

(b)(4).The event must be from prior 2008 since the article is published in 2007.Catalog#: unknown but referred to as a cook celect filter.Summary of investigational findings: image review demonstrated grade 2 and 3 interactions with the wall of the ivc, but no associated inflammatory changes involving the pancreas or retroperitoneal fat as reported.The fluoroscopic image status post deployment demonstrated the ivc filter with mild leftward tilt of 9°, but during removal a worsening leftward tilt measuring proximally 19° had developed.The filter had migrated caudally approx.3.5cm and the distance between primary filter had widened.The back pain improved after filter removal.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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.Lot# and rpn 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 of event according to article: before filter placement, a radiograph of the ivc was obtained that showed a patent vena cava measuring 19 mm in diameter.The filter deployment was uneventful, and the postprocedural radiograph confirmed satisfactory filter positioning and opening at the level of the l2 vertebral body.Nine days after filter placement and discharge, the patient presented to the hematology clinic with severe back pain, which had gradually worsened.A provisional diagnosis of retroperitoneal hemorrhage was made, and computed tomography (ct) of the abdomen and pelvis was performed, which showed all four primary struts of the filter well beyond the confines of ivc, consistent with transmural ivc penetration.The most displaced of these struts was the left anterolateral strut, which extended into the uncinate process of the pancreas.The remaining three struts were located in the retroperitoneal fat posterior to the aorta, right psoas muscle, and pancreaticoduodenal groove, respectively.Despite the extracaval location of the struts, no retroperitoneal hemorrhage, inflammation, or stranding was present.There was also no imaging evidence of pancreatitis.No other cause for the patient¿s back pain was demonstrated.In view of the ct findings it was decided to retrieve the filter.Before retrieval, a radiograph of the ivc was obtained, which showed an approximate 3-cm caudal migration of the filter from its original position at the level of the l2 vertebral body to the l3 level, resulting in a more horizontal orientation of the primary struts.A small amount of thrombus was present within the filter cone.The filter was snared, and other than significant pain during removal of the filter, there were no local or pulmonary complications.Through this same sheath, an optease retrievable filter was placed in the infrarenal ivc at approximately the same from the department of diagnostic imaging, the location, as verified on an ivc radiograph.Patient outcome: the patient¿s back pain improved, and she was discharged the following day and has since remained symptom-free.

• 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: 5534092
• MDR Text Key: 41417643
• Report Number: 3002808486-2016-00152
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061815
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• 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: 03/11/2016
• 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): Life Threatening
• Patient Age: 23 YR