MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466FXXXX

Device Problem Failure to Align (2522)

Patient Problems Coagulation Disorder (1779); Occlusion (1984); Perforation (2001); Patient Problem/Medical Problem (2688)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

As reported, a patient underwent placement of an optease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to tilting of the filter.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 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.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 department, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to tilting of the filter.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused tilting of the filter.The patient reported becoming aware of tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc) in addition to perforation abutting an adjacent organ, approximately fourteen years and eight months post implant.The patient also reported experiencing anxiety related to the filter and is also worried because the filter has become occluded, tilted, perforated and is abutting an adjacent organ.According to the implant records the patient was morbidly obese and was scheduled to undergo laparoscopic gastric bypass surgery.The filter was indicated as prophylaxis against perioperative thromboembolic complications.Of note, the patient had a history of deep venous thrombosis (dvt), with ultrasound documenting absence of flow in the left posterior tibial vein with no other evidence of dvt in the left leg.This was performed to evaluate left calf discomfort of several days duration after having intermittent left foot swelling for many months.The filter was placed via the right femoral vein and deployed at the level of l2-l3 interspace.Completion venogram documented excellent position of the filter to the wall.The filter retrieval hook was above the level of the iliac vein confluence.The patient was taken to the recovery room area in stable condition.There is currently no additional information available for review.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.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and vessel characteristics.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.It was reported that there was perforation of the ivc; however, a clinical conclusion could not be determined as to the cause of the event.A review of the instructions for use notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.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 or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.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 department, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to tilting of the filter.Per the implant records, the patient was morbidly obese and was scheduled to undergo laparoscopic gastric bypass surgery.The filter was indicated as prophylaxis against perioperative thromboembolic complications.Of note, the patient had a history of deep venous thrombosis (dvt), with ultrasound documenting absence flow in the left posterior tibial vein with no other evidence of dvt in the left leg.This was performed to evaluate left calf discomfort of several days duration after having intermittent left foot swelling for many months.During the procedure, there were multiple unsuccessful attempts made at percutaneous access of the femoral vein.Localization of the puncture using bony landmarks identified by fluoroscopy revealed that the palpable femoral pulsation was medial to the femoral head, leaving bony landmarks for localization somewhat unreliable given the unusual position of the femoral arterial pulsation.The femoral vein was eventually localized using ultrasound guidance.An inferior venacavagram was completed via right femoral percutaneous puncture using ultrasound guidance.The confluence of the iliac veins was at the mid body of the fourth lumbar vertebrae.The renal veins were not seen.The filter was advanced and deployed at the level of l2-l3 interspace.Completion venogram documented excellent position of the filter to the wall.The filter retrieval hook was above the level of the iliac vein confluence.The patient was taken to the recovery room area in stable condition.According to the information received in the patient profile form (ppf), the patient became aware of the reported events approximately fourteen years and eight months post implantation.The patient reports tilting of the filter, blood clots, clotting and or occlusion of the inferior vena cava (ivc) in addition to perforation abutting an adjacent organ.The patient also experienced anxiety related to the filter and is also worried because the filter has become occluded, tilted, perforated and is abutting an adjacent organ.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9706905
• MDR Text Key: 188350537
• Report Number: 1016427-2020-03804
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 0.018 GUIDEWIRE; UNK 0.035 ANGLED TIP GUIDEWIRE; UNK 5F MICROPUNCTURE SHEATH; UNK SHEATH
• Patient Outcome(s): Life Threatening