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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Catalog# is unknown but referred to as cook celect platinum filter.Occupation: non-healthcare professional.510(k): k171712.It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect platinum filter on (b)(6) 2017.It is alleged that the [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.".

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged perforation.Investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava perforation, migration, leg weakness, spasms, poor balance and physical limitations the reported allegations have been further investigated based on the information provided to date.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.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.Unknown if the reported leg weakness, spasms, poor balance and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged celect platinum 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.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

Patient allegedly received an implant on (b)(6) 2017 via the common femoral vein due to deep vein thrombosis (dvt), severe bleeding and pulmonary embolism (pe).Patient is alleging migration and vena cava perforation.The patient further alleges leg weakness, spasms, poor balance and physical limitations.Per a ct (computed tomography) scan of the abdomen and pelvis dated (b)(6) 2019, ¿axial ct abdomen and pelvis with coronal and sagittal reformatted images were submitted for review on 11/23/2019 of the ivc, filter position, and related findings.There are two (2) ivc filters present within the ivc.As per the operative report from the medical records, the cook celect migrated superiorly and a bard denali was placed infrarenal.The hook of the suprarenal cook celect retrievable ivc filter is within the right atrium at the level of the mid t10 vertebral body.The ivc filter is not tilted.All the struts of the ivc filter perforate the ivc up to 19mm.Two (2) anterior struts perforate the ivc wall 10mm and 11mm and contact the right hepatic lobe.One (1) medial strut perforates the ivc wall 18mm and contacts the crus of the diaphragm.Two (2) medial struts perforate the ivc wall 13mm and 15mm and contacts the caudate lobe.Three (3) posterior struts perforate the ivc wall 12mm, 12mm and 15mm and contact the right hepatic lobe.Two (2) lateral struts perforate the ivc wall both 19mm and contact the right hepatic veins.The hook of the bard denali retrievable ivc filter is at the l2-3 interspace.The ivc filter is tilted medially and the hook contacts the ivc wall.All the struts of the ivc filter perforate the ivc up to 20mm.Two (2) anterior struts perforate the ivc wall 13mm and 14mm and contact the bowel.One (1) posterior strut perforates the ivc wall 20mm and contacts the right psoas muscle.One (1) lateral strut perforates the ivc wall 12mm and contacts the bowel.Thrombus within the ivc or filter cannot be evaluated on this non-contrast study.No fracture fragments are identified.¿.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9635925
• MDR Text Key: 176554423
• Report Number: 3002808486-2020-00084
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 45