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

Catalog Number IGTCFS-65-JUG-CELECT-PERM

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Internal Organ Perforation (1987); Stenosis (2263); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: non-healthcare professional.Name and address for importer site:(b)(4).Investigation is still in progress.

Event Description

Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009".Additional information received 19oct2018: patient allegedly received an implant on (b)(6) 2009 due to deep vein thrombosis (dvt).Patient alleges tilt, organ perforation.Patient further alleges to have experienced: (b)(6) 2016 emergency room visit due to live bleeding; diagnosed ivc filter in dangerous place and needed to be removed; (b)(6) 2016, remitted with pneumonia; (b)(6) 2016, remitted with deep vein thrombosis (dvt); (b)(6) 2016, lung/liver complications (long term coumadin use required with ivc filter), hospital acquired c-diff infection twice; (b)(6) 2017, surgical hernia repair (damage, prior surgery); (b)(6) 2018, full abdominal reconstruction including multiple hernias and requiring mesh across entire abdomen (major damage prior surgery and extensive scarring).Attempted retrieval on (b)(6) 2016, due to significant leg perforation right gonadal vein and duodenum, one strut/leg left in vertebral body with bony remolding around filler leg, one leg abutting the aorta and moderate tilt, was unsuccessful.Patient outcome: filter successfully retrieved on (b)(6) 2017."successful inferior vena caval filter retrieval.The filter is intact.".

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: embedment, thrombotic occlusion, migration.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.The reported allegations have been further investigated based on the information provided to date.A filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.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 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.No relevant notes found on work order or device lot.No other complaints on lot.Product is manufactured and inspected according to specifications.Unknown if the reported bleeding is directly related to the filter and unable to identify a corresponding failure mode at this point in time.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 alleges stenosis, embedment, thrombotic occlusion, migration.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Investigation is reopened due to additional information provided.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect-tilt, vena cava and organ perforation, bleeding, diff retrieval, pneumonia, dvt, infection, hernia, depress, insomnia'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.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.Unknown if the reported unable to enjoy exrcise, insomnia, inability to lift heavy items, lung/liver complications is directly related to the filter and unable to identify corresponding failure mode(s) at this time.Unknown if the reported peripheral vein thrombosis is directly related to the filter and unable to identify a corresponding failure mode at this time.No relevant notes found on work order or device lot.No other complaints on lot.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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information provided at this time.

• Brand Name: COOK CELECT JUGULAR VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8040853
• MDR Text Key: 126219474
• Report Number: 3002808486-2018-01304
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2010
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2284974
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2018
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 68