MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Great Vessel Perforation (2152)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported in the literature by lee & roche-nagle (2021), a cook bird¿s nest inferior vena cava filter was noted to have penetrated an existing abdominal aortic aneurysm (aaa).The (b)(6) patient presented to a vascular surgery clinic for a swollen, erythematous, and tender left leg.The patient¿s medical history included a known infrarenal abdominal aortic aneurysm, high cholesterol, high blood pressure, multiple falls, a car accident two years prior to the visit, osteoarthritis of the hips, hypothyroidism, prostate cancer treated with brachytherapy, coronary artery disease involving right ventricular ischemia in the circumflex arteries, stage three chronic kidney disease, and smoking.A venous duplex scan was unable to rule out deep vein thrombosis (dvt) due to leg edema; however, an arterial duplex scan was unremarkable.An urgent ct angiogram (cta) was performed, revealing a left-sided proximal dvt with marked dilation of the left external iliac artery as well as the femoral and deep veins.Compression of the left external iliac vein was noted, resulting from a tortuous left internal iliac artery.The cta also noted that a strut of the bird¿s nest ivc filter was penetrating into the 5.5-centimeter infrarenal aortic aneurysm.No periaortic hematoma was noted.It is unknown why the ivc filter was originally placed.Per the authors, clinical notes were not available.The patient was treated with medication for the dvt.No intervention was required for the strut penetration, as the patient was asymptomatic.Reference: lee, j.& roche-nagle, g.2021.Permanent ivc filter strut penetration into an abdominal aortic aneurysm.Bmj case report.14:e241962.Doi:10.1136/bcr-2021-241962.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported in the literature by lee & roche-nagle (2021), a cook bird¿s nest inferior vena cava filter was noted to have penetrated an existing 5.5-centimeter infrarenal aortic aneurysm.It is unknown why the ivc filter was originally placed.No intervention was required for the strut penetration, as the patient was asymptomatic.Investigation - evaluation reviews of the instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.As no lot information was provided, reviews of the device history record and complaint history could not be performed.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.There is no indication that a design or process related failure mode contributed to the reported event.The device is provided with instructions for use which caution, ¿overly forceful or multiple jabs with the filter catheter/introducer sheath assembly could result in perforation of the wall of the inferior vena cava by the exposed hooks and struts of the filter.¿ the ifu also states, ¿vena cava wall penetration/perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall penetration/perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter), and (or) procedures that involve other devices being passed through an in situ filter.¿ based on the available information and a clinical assessment of the event, cook has concluded that the strut penetration is a known inherent risk of the device, as stated in the instructions for use.It is also likely that the patient¿s condition contributed to this event.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• 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: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13890703
• MDR Text Key: 287828919
• Report Number: 1820334-2022-00449
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K161218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• 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): Other
• Patient Age: 85 YR
• Patient Sex: Male