MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G34505

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

Patient Problems Pulmonary Embolism (1498); Thrombosis (2100); Perforation of Vessels (2135); 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 initial reporter: it is alleged that "[pt] received a celect filter on (b)(6) 2015".Patient allegedly received an implant on (b)(6) 2011 via the right femoral vein due to "deep vein thrombosis, pulmonary embolism and preoperatively for spinal surgery." patient is alleging "tilt, vena cava perforation, organ perforation, caval thrombosis, thrombosis in ivc".The first filter had prongs protruding outside wall of the ivc; suffered a caval thrombosis, and thrombosis in the ivcf((b)(4)); the current filter has moved backwards and is poking into my intestines ((b)(4)); and i experience chest cramping, and heaviness in chest area.I also experience anxiety, mental anguish and stress about the status of my filter and any related injuries." patient outcome: patient alleges "i am not certain which specific symptoms or bodily injuries i may have suffered as a result of the cook inferior vena cava filters.I am relying on the experts that will be retained by my lawyer to determine this information.

Event Description

No additional information at this time.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) 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 platinum - vc & organ perforation, migration, discomfort, anxiety, stress".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.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.Unknown if the reported discomfort is directly related to the filter.Unknown if the reported stress, anxiety is directly related to the filter and unable to identify a corresponding failure mode at this point in time.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.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.

Manufacturer Narrative

Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.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 report will be submitted should additional relevant information become 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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).G1) name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.

Event Description

Per implantation report, insert endovas vena cava filter, dated (b)(6) 2015, "a retrievable inferior vena cava filter was placed at the level of l1-2.".

Manufacturer Narrative

Device code(s): appropriate term/code not available (3191) was selected for the alleged venous perforation.Investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism, deep vein thrombus, chest cramping, chest heaviness.The reported allegations have been further investigated based on the information provided to date.New pe 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: pulmonary embolism.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.Unknown if the reported chest cramping, chest heaviness is directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.No other complaints on lot.Product is manufactured and inspected according to current controls.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 further alleges chest cramping and heaviness.

• Brand Name: COOK CELECT® PLATINUM NAVALIGN UNISET 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: 8159084
• MDR Text Key: 130168863
• Report Number: 3002808486-2018-01473
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345055
• UDI-Public: (01)10827002345055(17)180120(10)E3295578
• Combination Product (y/n): N
• PMA/PMN Number: K121629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2020

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: 01/20/2018
• Device Model Number: G34505
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT-PT
• Device Lot Number: E3295578
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/12/2018
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/21/2018; 05/01/2019; 12/16/2019
• Supplement Dates FDA Received: 01/16/2019; 05/16/2019; 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 81