MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number UNKFILTER

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

As reported, the patient was implanted an unspecified cordis inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to patient, including, but not limited to tilt.The filter remains implanted; thus, unavailable for analysis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The cordis vena cava filters are indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, the patient was implanted the cordis filter.The filter subsequently malfunctioned and caused injury and damage to patient, including, but not limited to: tilt.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.As reported by the legal brief, the patient was implanted the cordis filter.The filter subsequently malfunctioned and caused injury and damage to patient, including, but not limited to: tilt.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.

Manufacturer Narrative

According to the information received in the patient profile from (ppf), the patient discovered that her ivc filter had tilted on or around (b)(6) 2017.However, the patient was unaware that her injuries may have been a result of the defective product and an unreasonably dangerous condition of her filter until within two years of the filing of her complaint.A ct scan performed of the patient's ivc filter reported tilt.These injuries have caused emotional distress, mental anguish, anxiety and stress.In addition to the injuries listed, the patient is relying on the experts that will be retained by counsel to determine all injuries attributed to the device.The following additional information received per the medical records indicate that, bilateral pulmonary embolism, left lower extremity popliteal venous thrombus.The procedure involves the inferior venacavogram via the right basilic venous access.Transcatheter placement of the infrarenal ivc filter.Placement of the right upper extremity peripheral catheter.Moderate sedation utilizing iv versed and fentanyl with nurse monitoring 1645 to 1730 hours.A ct angiogram of the chest in bilateral lower extremity venous ultrasound image performed earlier on the same date were reviewed.The case was discussed with the consulting pulmonologist.Written informed consent was obtained.The right arm was sterilely prepped and draped tourniquet was applied and contrast material was ejected via peripheral iv access with adequate opacification of the basilic vein above the level of the right and antecubital fossa.Lidocaine was infiltrated in the subcutaneous soft tissue and the right basilic vein at the level of mid humerus was punctured utilizing 21-gauge micropuncture needle.Utilizing the wire exchange technique a6 french sheep was placed over a 0.035 exchange length rosen and wire to the level of the distal inferior vena cava.Contrast material was injected and demonstrates the inferior vena cava to be normal in diameter, normal anatomy.The diameter of the inferior vena cava was confirmed as was the level of the renal veins.The delivery sheath was placed just below the level of the renal veins, a retrievable ivc filter was deployed under direct fluoroscopic control.Follow up contrast injection demonstrates the inferior vena cava filter to be below the level of the renal veins with satisfactory flow and washout.After the above, the sheath was removed over a 0.35 wire.A 5french peel-away sheath was placed in a 41 centimeter, single lumen, 5 french catheter was positioned with its distal tip at the level of distal superior vena cava, confirmed with digital radiography.Hemostasis was obtained.The external portion of the catheter was secured, and a sterile dressing was applied.The patient was returned to the unit and stable condition.The above report was discussed with the consulting pulmonologist on the on call at the time it's performed.Complaint conclusion being updated with new information received: new codes of anxiety and previous codes of tilt.As reported, the patient was implanted the cordis optease inferior vena cava (ivc) filter.Per the medical records, the indication was bilateral pulmonary embolism (pe) with left lower extremity popliteal venous thrombus.A venocavogram demonstrated the ivc diameter and location of the renal veins.The retrievable filter was deployed below the level of the renal veins with satisfactory flow and washout.The filter subsequently malfunctioned including, but not limited to tilt.Per the patient profile from (ppf), the patient reports filter tilt and anxiety.A ct scan confirms the reported tilt.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the vena cava for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Without procedural films for review, the filter tilt reported could not be confirmed.Additionally, the timing and mechanism of the filter tilt is unknown.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: UNKNOWN VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 10268138
• MDR Text Key: 198920326
• Report Number: 9616099-2020-03785
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKFILTER
• Device Catalogue Number: UNKFILTER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR