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

Catalog Number IGTCFS-65-FEM-CELECT-PERM

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Pain (1994); Perforation of Vessels (2135); Distress (2329); Depression (2361); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

The following information is alleged: the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2010.The patient underwent a computed tomography (ct) scan approximately nine years then three months later, which, upon independent review approximately 10 months later, indicated that the three posterior filter struts were seen piercing the posterior wall by 8.35mm, 10.67mm, and 8.30mm.One of the posterolateral filter struts was seen piercing the posterior wall by 10.58 mm and was lying adjacent to the prevertebral structures.Another filter strut just anterior to the posterolateral strut was seen piercing the corresponding wall by 10.51 mm.The lateral filter strut was seen piercing the lateral wall by 10.11 mm and the medial filter strut was seen piercing the medial wall by 8.75 mm.There was a posterior and lateral tilt of 25 degrees of the filter that was noted; and that there was an anterior tilt of the filter of 25.22 degrees.The patient further alleged pain, distress, and limited mobility.The patient reportedly expired on (b)(6) 2021.Specific details surrounding the patient's expiration are currently unknown, and there is no reported allegation of wrongful death at this time.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation: the following allegations have been investigated: vena cava (vc) perforation, tilt, pain, distress, limited mobility.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 tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported pain, distress, and limited mobility are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to 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.

Event Description

Patient allegedly received an implant on (b)(6) 2010 due to motor vehicle accident followed by coma and blood clots in legs.Patient's representative is alleging tilt and vc perforation.They further allege post-implant blood clots and bipolar disorder.Patient reportedly expired 13may2021; however, no allegation of wrongful death has been received.Death certificate received.Medical opinion: "ivc filter is infrarenal in position.The three posterior filter strut is seen piercing the posterior wall (8.35mm), 10.67mm, 8.30mm ).(image 1, image 2, image 3).Another posterolateral filter strut is seen piercing the posterior wall (10.58 mm) and lying adjacent to the prevertebral structures.(image 4).Just anterior to the posterolateral strut is seen another strut piercing the corresponding wall (10.51mm).(image 5).The lateral filter strut is seen piercing the lateral wall (10.11mm).(image 6).The medial (16mm) filter strut is seen piercing the medial wall (8.75mm).(image7).Posterior and lateral tilt (25 degrees) of the ivc filter is noted.(image 9).There is anterior tilt of filter is noted (25.22deg).(image 8).No ivc filter fracture noted." certificate of death: immediate cause: cerebrovascular accident.Due to (or as a consequence of): hypertensive heart disease, chronic kidney disease stage 4, diabetes mellitus.History of dvt (deep vein thrombosis).

Manufacturer Narrative

Additional information: investigation.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: deep vein thrombosis (dvt), bipolar.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 bipolar disorder is directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # is known but the lot # is unknown.The alleged celect filter 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.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14315803
• MDR Text Key: 291240858
• Report Number: 3002808486-2022-00294
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Male
• Patient Weight: 73 KG