MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number BNF-40-PB

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Non-healthcare professional.Investigation device master record (dmr) review in response to this incident, cook completed a review of the product dmr.The following controls are in place to address the reported failure mode: bird¿s nest filter with push button release lists the standard materials, dimensions and appearance criteria required to create the bird¿s nest filter.Bird¿s nest filter template gives a template of the appropriate size of assembly, length of wires and bend of angle for the filter struts.The complaint device was built to specification frameworks the process prepping, soldering, cleaning, forming and curling the bird¿s nest.In-process inspection for uncurled filter of the bnf-pb states - inspect all sections 100%, unless otherwise specified.Insure correct length center wire extending between the two middle cannulas.Inspection method: measure with meter stick, holding at proximal and distal soldered cannulas.Insure correct size wire has been used to assemble the filter as follows: a.Verify outside diameter of wire used for center wires.Inspection method: level i, measure with micrometer or caliper.B.Verify outside diameter of wire used on outside of filter.Inspection method: level i, measure with micrometer or caliper.C.Verify outside diameter of wires used on distal and proximal end of filter.Inspection method: level i, measure with micrometer or caliper.Final inspection for gianturco-roehm bird¿s nest vena cava filter states that the individual should: 100% inspect all sections of the device unless otherwise specified.Inspect all steps 100% unless otherwise specified.Inspect at level 1 to verify the filter releases properly.Verify proximal end of filter exits smoothly and completely.Verify curls of filter are appropriately formed.Verify smooth separation of filter.Verify filter has been previously inspected by visually examining the work order for subassembly work order number.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Review of product labeling cook also reviewed product labeling.The product ifu, ¿gianturco-roehm bird¿s nest vena cava filter for femoral placement,¿ and ¿gianturco-roehm bird¿s nest vena cava filter for jugular placement¿ provides the following information to the user related to the reported failure mode: potential adverse events include, but are not limited to: filter migration (may occur if proper anchoring techniques are not utilized) inferior vena cava thrombosis perforation of vena cava wall hematoma at puncture site device history record (dhr) review due to missing lot and rpn information, a review of the device history record (dhr) could not be completed.At this time, cook concludes that there is no evidence of nonconforming product in house or in the field.Design history file (dhf) review testing and validation allstate solder bird's nest filter in implants process validation summary allstate solder bird's nest filter in implants validated process review report device failure analysis the complainant did not return the complaint device to cook for investigation.At this time, no visual, dimensional, or functional verifications could be completed.Cook could not conclude that the device was manufactured out of specification.Conclusion a definitive conclusion could not be determined.The risk analysis for this failure mode was reviewed and no additional escalation was required.The complaint was confirmed based on customer testimony.Cook will continue to monitor for similar complaints.A device master record (dmr) review was performed, and device drawings, specifications, and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) could not be completed due to the missing lot number and rpn.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.The complaint device was not returned to cook for investigation.At this time, a device failure analysis could not be completed.The information provided upon review of the dmr, dhf, and ifu, suggest that there is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.The complaint was confirmed based on customer testimony.Cook could not conclude a cause of failure at this time.The risk analysis for the failure mode was reviewed and it was determined that no escalation actions were required.The appropriate personnel will be notified, and cook will continue to monitor for similar complaints.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 following information is alleged: the patient received a bird's nest inferior vena cava (ivc) filter on (b)(6) 2001 due to having a conjunction with or before bariatric procedure.Approximately 19 years and 5 months after receiving the filter implant, the patient had an x-ray of the abdomen to evaluate the indwelling ivc filter which revealed that the filter had broken into at least 3 pieces present at the level of the l3, l4, and l5 vertebral bodies presumably within the ivc.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Investigation: it was reported to cook that a patient received an bird's nest filter (bnf-40-pb) from lot 1094816.The following information is alleged: patient allegedly received an implant on (b)(6) 2001 via the right common femoral vein due to bariatric procedure.Patient is alleging fracture.Patient further alleges "chest pains." patient can no longer engage in "lifting heavy stuff." per computed tomography (ct) report, "the ivc filter in this patient has broken into at least three pieces present at the level of the l3, l4 and l5 vertebral bodies presumably within the inferior vena cava.".A device master record (dmr) review was performed, and device drawings, specifications, and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for lot 1094816 revealed no reported nonconformances.A database search revealed no other complaints have been reported for the device lot.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.The complaint device was not returned to cook for investigation.At this time, a device failure analysis could not be completed.The information provided upon review of the dmr, dhr, dhf, and ifu, suggest that there is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.The complaint was confirmed based on customer testimony.Cook could not conclude a cause of failure at this time.The risk analysis for the failure mode was reviewed and it was determined that no escalation actions were required.The appropriate personnel will be notified, and cook will continue to monitor for similar complaints.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

Patient allegedly received an implant on (b)(6) 2001 via the right common femoral vein due to bariatric procedure.Patient is alleging fracture.Patient further alleges "chest pains." patient can no longer engage in "lifting heavy stuff." per computed tomography (ct) report, "the ivc filter in this patient has broken into at least three pieces present at the level of the l3, l4 and l5 vertebral bodies presumably within the inferior vena cava.".

• Brand Name: GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16826550
• MDR Text Key: 314124930
• Report Number: 1820334-2023-00521
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/29/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2004
• Device Catalogue Number: BNF-40-PB
• Device Lot Number: 1094816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2001
• 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: 90 KG