MAUDE Adverse Event Report: COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-FEM

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Thrombus (2101); Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.(b)(4).Investigation: the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture (fragment left in patient), vena cava (vc)/organ perforation, occlusive caval thrombus, tilt.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.A total of (b)(4) devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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 will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.

Event Description

Patient allegedly received an implant on (b)(6) 2008 via right common femoral vein due to immobility and status post pelvic trauma.Patient is alleging fracture.Per a computerized tomography (ct) scan of the abdomen and pelvis dated (b)(6) 2017, ¿note is made of an ivc filter in place.The filter demonstrates approximately 11 degrees of right lateral tilt from axis of the ivc itself.The apex of the ivc filter touches the right anterior lateral aspect of the ivc wall.The tip of the ivc filter is located at the level of the left renal vein.The left anterior lateral strut (1:00 on the axial images) extends approximately 6 mm beyond the ivc wall and immediately abuts the second portion of the duodenum.The left posterior lateral strut (4:00 on axial images) extends approximately 17 mm beyond the ivc wall and is immediately juxtaposed to the anterior aspect of the vertebral body with evidence of osseous remodeling.The right posterior strut (7:00 on axial images) extends approximately 9 mm beyond the ivc wall and indents upon the anterior aspect of the right psoas muscle.The right anterior strut (10:00 on axial images) appears to remain within the ivc lumen.The ivc itself appears normal in caliber.¿ per a venogram bilateral lower extremities, thrombectomy dated (b)(6) 2019, ¿impression: occlusive caval thrombus from the iliocaval confluence through the level of the ivc filter.¿ per an interventional radiology (ir) ivc filter removal operative report dated (b)(6) 2019, ¿successful retrieval of an inferior vena cava filter, small retained fragment of ivc filter remaining, likely anomaly extraluminal in position.No embolized fragments were identified overlying the right or left chest.¿ /gjs 26feb2020.

• Brand Name: GUNTHER TULIP FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9772129
• MDR Text Key: 192761003
• Report Number: 1820334-2020-00510
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2011
• Device Catalogue Number: IGTCFS-65-FEM
• Device Lot Number: 2104461
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2008
• 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