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 Unintended Movement (3026); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Aneurysm (1708); Hematoma (1884); Perforation of Vessels (2135); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Name and address for importer site: (b)(4).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 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 via the right femoral vein due to deep vein thrombosis and prevention of pulmonary embolism.Patient is alleging "tilt, vena cava perforation, bleeding, aneurysm, retroperitoneal hematoma, and required removal of filter".The patient further alleges "that they were taken to the emergency room on or around (b)(6) 2017 due to excruciating back, chest, abdominal, leg and groin pain.A ct scan revealed that the filter had tilted and perforated the ivc wall.It was also discovered that he had a retroperitoneal hematoma caused the one of the limbs of the filter nicking his artery.Patient then had to have emergency surgery to repair the damage.The filter was successfully removed on or about (b)(6) 2017".

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.Patient code: vessels, perforation of (2135)- listed in ifu, hematoma (1884) - not listed in ifu, aneurysm (1708) - not listed in ifu.Device code: unintended movement (3026)- not listed in ifu, appropriate term/code not available (3191) - [device perforation]- listed in ifu.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 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.

Manufacturer Narrative

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.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-pt - tilt, vena cava perforation, bleeding/retroperitoneal hematoma, aneurysm, difficult retrieval, pain".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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.Unknown if the reported pain, bleeding, retroperitoneal hematoma is directly related to the filter.Unknown if the reported aneurysm is directly related to the filter and unable to identify a corresponding failure mode at this point in time.No relevant notes found on work order or device lot.One other complaint on lot and related to similar clinical issues (pain, hematoma, and pseudo aneurysm) and 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.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® 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: 7994399
• MDR Text Key: 124659825
• Report Number: 3002808486-2018-01225
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: IGTCFS-65-1-FEM-CELECT-PT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/04/2018
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Weight: 97