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

Catalog Number 466FXXXX

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009); Unintended Movement (3026); Migration (4003)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Unspecified Tissue Injury (4559)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported by the legal brief, 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 perforation, migration and tilting.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 suffer significant medical expenses, pain and suffering and other damages.

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 perforation, migration and tilting.The patient reported becoming aware of the events approximately ten years and eight months post implant.The patient also reported leg swelling, depression and anxiety related to the filter.According to the medical records, the patient was reported to have a history of asthma, chronic obstructive pulmonary disease, tobacco abuse, obstructive sleep apnea, diabetes and morbid obesity.Prior to the index procedure, the patient developed increased leg, calf tenderness and pain and was evaluated at the hospital and was found to have acute deep vein thrombosis (dvt) and acute pulmonary embolism (pe), and was noted to be coumadin noncompliant.The filter was indicated for recurrent pe and the inability to adequately control anticoagulation therapy.The filter was placed via the right common femoral vein and deployed with the tip at the mid-level of l2, where an inferior venacavogram demonstrated the level of the renal veins at the l1-2 level.The patient tolerated the procedure well without immediate complications.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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such.Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Anxiety and leg swelling do not represent a device malfunction and may be related to underlying patient specific issues.Without images available for review the reported events could not be confirmed or further clarified.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, 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 perforation, migration and tilting.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 suffer significant medical expenses, pain and suffering and other damages.According to the medical records, the patient was reported to have a history of asthma, chronic obstructive pulmonary disease, tobacco abuse, obstructive sleep apnea, diabetes and morbid obesity.Prior to the index procedure, the patient developed increased leg, calf tenderness and pain and was evaluated at the hospital and was found to have acute deep vein thrombosis (dvt) and acute pulmonary embolism (pe), and was noted to be coumadin noncompliance.The filter was indicated for recurrent pe and the inability to adequately control anticoagulation therapy.Under sterile conditions, utilizing fluoroscopic and ultrasound guidance, the right common femoral vein was accessed with a needle using seldinger technique.A guidewire was advanced into the vein followed by the optease delivery catheter.An inferior venacavogram demonstrated the level of the renal veins at the l1-2 level.The filter was placed with its tip at the mid l2 level.The patient tolerated the procedure well without immediate complications.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the inferior vena cava (ivc), tilting of the filter and migration becoming aware of these events approximately ten years and eight months after the filter implantation.The patient further experienced swelling of the legs, depression and anxiety related to the filter.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12175892
• MDR Text Key: 261893419
• Report Number: 1016427-2021-05088
• 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: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 18-GAUGE NEEDLE, UNK GUIDEWIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR