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

Model Number	G52915
Medical Device Problem Codes	Structural Problem (2506); Device Tipped Over (2589); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation of Vessels (2135); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial 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 or Problem Description
It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2013, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
Additional Manufacturer Narrative
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: vena cava perforation, tilt, abdominal pain limits activity, and fear.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 abdominal pain limits activity and fear is directly related to the filter and unable to identify a corresponding failure mode at this point in time.(b)(4) devices in lot.To date, no other complaints have 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 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 or Problem Description
Patient allegedly received a filter via the right common femoral vein due to obesity.Patient is alleging device tilt and vena cava perforation.Patient notes and further alleges experiencing "fear", stomach pain during exercise limits activity.Per a computed tomography (ct) abdomen: "the ivc filter is slightly tilted, apex towards the left side abutting the vessel wall.The ivc filter is below the renal veins.The ivc filter struts are intact without fractures or bending.They expand slightly beyond the vessel wall without perforation.1 of the struts gently abuts the distal aorta.There is no inferior vena cava stenosis".
Additional Manufacturer Narrative
Investigation: investigation is reopened due to additional information provided.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.20 devices in lot.No other complaints have 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 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 or Problem Description
Per a ct abdomen: "filter type: cook.Ivc stenosis: no.Filter cone position: below the renal veins.Filter migration: none.Filter fracture/bending: no.Filter tilt: yes.Filter penetration: yes.Other findings: no.Impressions: the filter is tilted to the left and its cone is against the ivc wall, coronal image 27.The right side filter leg perforates 11 mm through the ivc wall, coronal image 27.The left side filter leg perforates 13 mm through the ivc wall, coronal image 26.The anterior filter leg perforates 9 mm through the ivc wall, sagittal image 40.The posterior filter leg perforates 7 mm through the ivc wall, sagittal image 108.

• Brand Name: COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
• Common Device Name: 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: 13606157
• Report Number: 3002808486-2022-00158
• Device Sequence Number: 1856973
• Product Code: DTK
• UDI-Device Identifier: 10827002529158
• UDI-Public: (01)10827002529158(17)160228(10)E3053181
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: G52915
• Device Catalogue Number: IGTCFS-65-1-UNI-CELECT
• Device Lot Number: E3053181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022; 01/06/2023
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/31/2022; 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female
• Patient Weight: 147 KG