MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G48373

Device Problems Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Section e3: non-healthcare professional.Investigation: the following allegations have been investigated: fracture, organ/aorta/vena cava (vc) perforation, migration.The reported allegations have been further investigated based on the information provided to date.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.20 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

The patient allegedly received a celect inferior vena cava (ivc) filter on (b)(6) 2012 via the right femoral vein.(b)(6) 2013, per a report from computed tomography; ¿impression: overall unchanged position of the inferior vena cava filter at level of l1-l2.Several of the filter anchor tips appear to course beyond the margins of the caval wall.¿.(b)(6) 2013, per a report from computed tomography; ¿there is an ivc filter in place.Segments of the filter legs appear to pass through the wall of the inferior vena cava.¿.(b)(6) 2018, per a report from computed tomography; "there is redemonstration of an inferior vena cava filter located in the infrarenal ivc, unchanged in longitudinal position, with marked interval increase in strut extension through the ivc wall, including a right anterior strut extending approximately 2 cm toward the right lower quadrant, in vicinity of multiple loops of small bowel, a left anterior strut appearing to extend through the right infrarenal aortic wall, and a posteriorly directed strut extending through the superior endplate· of the 13 vertebral body.No evidence of active hemorrhage or hematoma formation".¿impression: 1.Interval increase in extension of multiple ivc filter struts beyond the wall of the infrarenal ivc with left anterolateral strut appearing to extend through the right lateral wall of the infrarenal abdominal aorta.No evidence of active extravasation or hematoma.¿.(b)(6) 2022, per a report from computed tomography; ¿ivc filter migration.Impression: ivc filter with limbs penetrating the ivc wall.One anterolateral limb compressing or conceivably within the wall of the infrarenal aorta.Another limb penetrates the right anterior psoas muscle.2 separate, likely fractured limbs, one within the l3 vertebral body and another along side or within the lateral wall of the cecum inferior to the liver.¿.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16796169
• MDR Text Key: 313832898
• Report Number: 3002808486-2023-00113
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00827002483736
• UDI-Public: (01)00827002483736(17)131027(10)E2822930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2023

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: 10/27/2013
• Device Model Number: G48373
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2822930
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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 Sex: Female