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

Catalog Number IGTCFS-65-1-FEM-CELECT-PT

Device Problems Collapse (1099); Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100); Perforation of Vessels (2135); Weakness (2145); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date.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 abscessed filter is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported retroperitoneal bleed is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Unknown if the reported acute arterial hemorrhage is directly related to the filter and unable to identify a corresponding failure mode at this point in time.No evidence to suggest that this product was not manufactured according to specification.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to categorization form: pt alleges:"ivc is collapsed around filter (chronic ivc stenosis", "ivc is collapsed around the apex of filter (chronic ivc stenosis)", "massive deep venous thromboses", "abscessed ivc filter", "retroperitoneal bleed, acute arterial hemorrhage" additional information received (b)(6) 2019: it is alleged that "pt received a cook celect filter on (b)(6) 2017".Patient outcome: it is alleged that pt was injured without further explanation.Hospital and medical records have been requested but not yet provided.

Event Description

Patient allegedly received an implant on (b)(6) 2017 due to deep vein thrombosis (dvt) via the common femoral vein.Patient alleges vena cava perforation, bleeding, acute arterial hemorrhage, massive deep venous thrombosis, stenosis, retroperitoneal bleed, abscessed filter.Patient further alleges to have experienced, "bleeding disorders, anti-coagulant caused bleeding, numerous blood transfusion, weakness caused falls and caused left hip replacement and vertebrae damages".Per abdominal ct, dated (b)(6) 2017, "there is low density in the ivc in the filter chamber and distal to the filter that is thought to represent acute thrombud.The ivc is collapsed around the apex of the filter.The is suggested chronic ivc stenosis.".

Manufacturer Narrative

Investigation still in progress.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.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.

Manufacturer Narrative

Reference also manufacturer report number: 3002808486-2019-00776.Investigation: the investigation is reopened due to additional information provided.The following allegations have been investigated: bleeding, massive deep venous thrombosis, abscessed filter; bleeding disorders, anti-coagulant caused bleeding, numerous blood transfusion, weakness caused falls & left hip replacement and vertebrae damages, limitations on walking/strength/any activity, and vena cava perforation.The reported allegations have been further investigated based on the information provided to date.Vena cava wall penetration/perforation has been reported and 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.Unknown if the reported bleeding, massive deep venous thrombosis, abscessed filter; bleeding disorders, anti-coagulant caused bleeding, numerous blood transfusion, weakness caused falls & left hip replacement and vertebrae damages, and limitations on walking/strength/any activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No other complaints on lots.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 further alleges limitations on "walking, strength, any activity.".

• Brand Name: COOK CELECT® PLATINUM NAVALIGN FEMORAL 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: 8726392
• MDR Text Key: 148973937
• Report Number: 3002808486-2019-00775
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 08/21/2019

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: 02/18/2020
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: E3549939
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/31/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 05/29/2019; 07/22/2019
• Supplement Dates FDA Received: 06/27/2019; 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 64