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); Appropriate Term/Code Not Available (3191)

Patient Problems Perforation of Vessels (2135); Anxiety (2328); Depression (2361); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect 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.

Event Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2010, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, a4, b1, b2, b5, b6, b7, d1, d4, g4, h4, annex e, annex f, annex a, annex b, annex c, annex d, and h6.Investigation the following allegations have been investigated: vena cava (vc) perforation, occlusion/deep vein thrombosis (dvt), tilt, thrombectomy, fear, anxiety, lifetime blood thinners, and depression.Investigation is reopened due to additional information provided.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.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 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 thrombectomy, fear, anxiety, lifetime blood thinners, and depression are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, there were two other complaints which had been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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 received an implant on (b)(6) 2010 prior to bariatric surgery followed by a successful, complex retrieval (b)(6) 2018.The patient alleges tilt, vena cava perforation, occluded filter, and deep vein thrombosis (dvt) bilateral common ivc requiring thrombectomy.The patient further alleges fear, anxiety, lifetime blood thinners, and depression.(b)(6) 2018 magnetic resonance imaging (mri) abdomen: "impression: mri confirms what appears to be extensive acute thrombus in the ivc below the ivc filter, extending through the length of the left common iliac and into a large left lumbar vein.3.No thrombus extends above the ivc filter.The ivc above the filter appears normal".(b)(6) 2018, per a report from venogram; ¿findings: persistent 50% thrombus in distal ivc, 20% in proximal left common iliac vein.No thrombus in ivc filter.¿ "final impression: suspect aneurysmal dilatation of the inferior vena cava and the left common iliac vein.Acutely thrombosed bilateral common iliac veins and inferior vena cava were successfully opened with pharmacal-mechanical thrombectomy using the angiojet device.Ivus identification of residual thrombus within the dilated left common iliac and ivc".(b)(6) 2018, per a report from (partial) retrieval report (successful); ¿final impression: safe retrieval of a celect ivc filter.No evidence of thrombus or inferior vena cava injury after filter retrieval.¿.

• Brand Name: COOK CELECT FEMORAL VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• MDR Report Key: 11844393
• MDR Text Key: 251394459
• Report Number: 3002808486-2021-01219
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K073374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2012
• Device Catalogue Number: IGTCFS-65-FEM-CELECT-PERM
• Device Lot Number: E2560254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 81