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

Model Number	G48372
Medical Device Problem Codes	Structural Problem (2506); Device Tipped Over (2589)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Depression (2361)
Type of Reportable Event	Serious Injury
Event or Problem Description
It is alleged that "patient received a cook celect filter.Patient is alleging perforation of organ.Hospital and medical records have not been provided.".
Additional Manufacturer Narrative
(b)(6).Initial reporter occupation: non-healthcare professional.Investigation: 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.Rpn/lot is unknown, however, the device is manufactured and inspected according to current 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.This report includes information known at this time.A follow up report will be submitted should additional information become available.
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.Cook will reopen the investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 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 or Problem Description
Additional information provided the patient allegedly received the celect filter on (b)(6) 2011.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b5, annex e, annex a, annex g, annex b, annex c, annex d, and h6.Investigation.The following allegations have been investigated: organ/vena cava perforation, tilt.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.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.20 devices in lot.No relevant notes on work order.The 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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.The reported allegation has been investigated.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.Product is manufactured, inspected and packaged by william cook europe a/s.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 or Problem Description
The patient allegedly received an implant on an unknown date.The patient alleges that multiple prongs perforate the inferior vena cava (ivc), one prong perforates the l3 vertebral body, a second prong abuts the abdominal aorta, and tilt.
Event or Problem Description
Patient allegedly received an implant on (b)(6) 2011 via the right internal jugular vein due to extensive pulmonary embolus (pe), large right lower leg extremity deep venous thrombosis (dvt).The patient alleges perforation abutting another organ.The patient further alleges multiple prongs perforate the inferior vena cava (ivc), one prong abuts the aorta, another prong perforates the l3 vertebral body, anxiety, worry, fear, limited activity, and depression.Per a report from computed tomography; ¿caval perforation: yes.3 o'clock 9.00mm grade 3 extending to the anterior periphery of the abdominal aorta.12 o'clock 10.30mm grade 2.9 o'clock 3.70mm grade 2.6 o'clock 7.30mm grade 4 extending into the l3 vertebral body.Tilt: yes.Posterior tilt measuring 15.62 degrees.Right-sided tilt measuring 7.05 degrees.Migration: no.¿.
Additional Manufacturer Narrative
The following fields were updated per additional information received: a4, b5, b6, b7, annex e, annex a, annex g, annex b, annex c, annex d, and h6.Investigation the following allegations have been investigated: anxiety, worry, fear, limited activity, depression.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported anxiety, worry, fear, limited activity, 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.No relevant notes on work order.The 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.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 JUGULAR VENA CAVA FILTER SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 14444759
• Report Number: 3002808486-2022-00594
• Device Sequence Number: 4311219
• Product Code: DTK
• UDI-Device Identifier: 00827002483729
• UDI-Public: (01)00827002483729(17)130308(10)E2714446
• Combination Product (Y/N): N
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2022

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 Model Number: G48372
• Device Catalogue Number: IGTCFS-65-JUG-CELECT-PERM
• Device Lot Number: E2714446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/13/2022; 08/24/2022; 09/16/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 08/10/2022; 08/30/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2011
• 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: 91 KG