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

Catalog Number IGTCFS-65-UNI-CELECT-PERM

Device Problems Structural Problem (2506); Appropriate Term/Code Not Available (3191)

Patient Problems Nerve Damage (1979); Internal Organ Perforation (1987); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2008, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Event Description

Patient allegedly received a filter via the right femoral vein prior to bariatric surgery.Patient is alleging organ perforation.Patient notes and further alleges experiencing "permanent nerve damage.Have blood thinners the rest of my life", physical limitations.Per a ct abdomen: "lnfrarenal ivc is in place.Ivc is placed along the course of the ivc with no significant tilt.The cranial tip of the filter is approximately 2.5 cm caudal to the origin of the renal veins.4 struts of the ivc filter had perforated.One into the right iliopsoas muscle, into a loop of small bowel, one into the anterior mesenteric fat, and the last into the retroaortic space at the level of the bifurcation.There is no evidence of filter struts fracture or bending.The ivc is normal in caliber".

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: organ perforation, nerve damage, lifelong anticoagulation, physical limitations.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.Unknown if the reported nerve damage, lifelong anticoagulation, and physical limitations 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, 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.

• Brand Name: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632
• Manufacturer Contact: lissi walmann ; sandet 6; bjaeverskov 4632 ; 56868686
• MDR Report Key: 12169755
• MDR Text Key: 261755364
• Report Number: 3002808486-2021-01603
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073374
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Device Lot Number: E2146501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2021
• 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: Female
• Patient Weight: 112 KG