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

Catalog Number IGTCFS-65-1-UNI-CELECT

Device Problems Structural Problem (2506); Device Tipped Over (2589)

Patient Problems Itching Sensation (1943); Internal Organ Perforation (1987); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Catalog # is unknown but referred to as celect.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

The following information is alleged: the patient received a celect inferior vena cava (ivc) filter in (b)(6) 2012.Approximately 5 years and 6 months after receiving the filter implant, the patient underwent a computerized tomography (ct) scan which revealed that the cook ivc filter had moved since its implantation as several struts of the cook filter were now perforating through the ivc wall with one of the struts abutting the abdominal aorta.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Investigation: 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 the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Catalog number and lot number are unknown; however, there is 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.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 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.

Event Description

The patient received a celect inferior vena cava (ivc) filter on (b)(6) 2012.

Manufacturer Narrative

Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: organ/ vena cava (vc) perforation, embedment, tilt, itching.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ/ vena cava (vc) perforation, embedment, tilt, itching.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 itching is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.No relevant notes on wo for neither device (igtcfs-65-1-uni-celect) lot: e2798778, nor filter (igtf-30-celect) lot: e2793060 and e2797866.One other complaint on lots ((b)(4) - similar issue).Product is manufactured and inspected according to specification.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 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.

Event Description

Patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to post deep vein thrombosis (dvt).Patient is alleging organ and vena cava perforation, tilt, and embedment.Patient notes and further alleges experiencing "itching".Per computed tomography report, "an infrarenal ivc filter is in place with posterior tilt.The filter apex abuts the posterior wall of the ivc.No extension beyond the wall.Several of the distal struts protrude beyond the ivc wall into the right surrounding the retroperitoneal fat.A right lateral strut extrudes 5.4 mm from the wall, a right posterior strut protrudes 4.7 mm from the wall a posterior medial strut projects in the aorto caval interspace abutting the outer wall of the aorta without perforation.An anterior strut protrudes 3.8 mm from the wall.".

• Brand Name: COOK CELECT NAVALIGN JUGULAR & 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 ; 56868686
• MDR Report Key: 12469061
• MDR Text Key: 271456110
• Report Number: 3002808486-2021-01790
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2014
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT
• Device Lot Number: E2798778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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: 61 KG