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

Model Number 466FXXXX

Device Problems Fracture (1260); Failure to Align (2522)

Patient Problem Perforation of Vessels (2135)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown; stated to be in 2009.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of an optease retrievable vena cava filter.The patient is reported to have presented to hospital with a possible pulmonary embolism (pe) and underwent filter implantation.Approximately nine years after the filter implantation, the patient had undergone a computerized tomography (ct) scan that revealed that the filter had tilted postero-medially with the posterior medial strut fractured and/or broken distally with a grade i perforation of less than 3mm in the lower segment.These findings are reported to have required treatment including anticoagulation therapy.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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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.Without images or procedural films for review, the reported filter tilt, fractured and perforation events could not be confirmed and the exact cause could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuousness.Additionally, the timing and mechanism of the filter tilt is unknown.The timing and mechanism of the fracture has not been reported at this time.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.It is unknown if the tilt contributed to the reported perforation.A review of the ifu notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Clinical factors that may have influenced the event include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in 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 underwent placement of a optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages including, but not limited to: tilt, fracture, grade i perforation.A ct scan of his chest (pe protocol) performed approximately 9 years post implantation showed his ivc filter was present in expected location.The ivc filter was tilted posteromedially.The postero-medial strut was fractured/broken distally with grade i perforation (<3mm) of the lower segment.This condition progressed causing injuries, including injuries requiring medical treatment and hospitalization and anticoagulation therapy.Despite causing or contributing to clot formation, the ivc filter cannot safely be removed.

Manufacturer Narrative

As reported, the patient underwent placement of a optease inferior vena cava (ivc) filter.Per the medical records, history includes hypertension, acid reflux, automated implantable cardioverter defibrillator (aicd), anemia, chest pain, chronic anticoagulation, atrial fibrillation, back pain, obesity, congestive heart failure (chf), compression fracture of the vertebrae, gout, coronary artery bypass grafting (cabg), chronic kidney disease, inferior vena cava (ivc) filter, depression and anxiety.The indication for filter insertion has not been provided.The filter malfunctioned including tilt, fracture, and grade i perforation.A ct scan approximately 9 years post implant showed the ivc filter was present in expected location, tilted, and the postero-medial strut was fractured/broken distally with grade i perforation (<3mm) of the lower segment.Approximately seven years and six months after implant, imaging revealed degenerative changes to the left shoulder acromioclavicular joint.Approximately nine years and seven months post implant, a chest computed tomography (ct) revealed no thoracic aneurysm or dissection, status post coronary artery bypass grafting (cabg), no acute congestive heart failure (chf) or infiltrates, cardiomegaly and a moderate hiatal hernia.These images were reviewed later and revealed mild tilting of the ivc filter, posteromedial strut fracture with grade i perforation.Approximately ten years after implant, the patient was seen for a productive cough with upper respiratory infection.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.The instructions for use (ifu) states filter fracture, associated to perforation of the ivc and/or surrounding organs and structures, is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.The fractured portion may erode or perforate through the ivc and into adjacent tissues.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.

Manufacturer Narrative

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

Event Description

Additional information received per the medical records indicate that the patient has a history of hypertension, acid reflux, automated implantable cardioverter defibrillator (aicd), anemia, chest pain, chronic anticoagulation, atrial fibrillation, back pain, obesity, congestive heart failure (chf), compression fracture of the vertebrae, gout, coronary artery bypass grafting (cabg), chronic kidney disease, inferior vena cava (ivc) filter, depression and anxiety.Approximately seven years and six months after the index procedure, left shoulder imaging revealed degenerative changes to the acromioclavicular joint.Approximately nine years and seven months after the index procedure, a chest computed tomography (ct) revealed no thoracic aneurysm or dissection, status post coronary artery bypass grafting (cabg), no acute congestive heart failure (chf) or infiltrates, cardiomegaly and a moderate hiatal hernia.These images were reviewed later and revealed mild tilting of the inferior vena cava (ivc) filter, posteromedial strut was fractured with grade i perforation.Approximately ten years after the index procedure, the patient was seen for a productive cough with upper respiratory infection.

Manufacturer Narrative

The additional information received is listed below: date of birth: (b)(6) 1952, weight: 328 pounds, height: 6 feet 2 inches.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9474447
• MDR Text Key: 171976986
• Report Number: 1016427-2019-03672
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2021

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 Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 04/19/2021; 05/19/2021; 11/23/2021
• Supplement Dates FDA Received: 05/18/2021; 06/02/2021; 12/14/2021
• 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): Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 149 KG