MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problem Fracture (1260)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 06/16/2020

Event Type  Injury  

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 a fractured strut.The indication for the filter implant, procedural details and medical history of the patient have not been provided.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 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.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.Without images available for review the reported event could not be confirmed or further clarified.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 in 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 a fractured strut.As a direct and proximate result of this malfunction, 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

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 a fractured strut.The patient reported becoming aware of fractured filter struts retained in the body, approximately four years and eleven months post implant.The patient also reported anxiety and depression related to the filter.According to the medical records, the patient had a history of obesity, pulmonary embolism (pe), deep vein thrombosis (dvt) in the legs, human immunodeficiency virus, chronic obstructive pulmonary disease, cerebrovascular accident, pleurisy, recurrent urinary tract infections, recurrent cystitis, and heavy vaginal bleeding, c-section, neck surgery, appendectomy, back surgery, and knee surgery.The patient was also wheelchair bound.The patient presented to the emergency room (er) with chest pain in the left lower ribcage for two days.A computerized tomography (ct) angiogram of the chest was positive for multiple right-sided pulmonary emboli, basilar interstitial lung changes with atelectasis and small bilateral pleural reactions.The patient was experiencing shortness of breath and was found to have severe anemia, requiring blood transfusion.According to the implant record the indication for the filter implant was recurrent pe and dvt.The filter was placed via access from the right groin and deployed below the renal veins with good position.The patient tolerated the procedure very well with no significant complication.About four years and eleven months post implant, an abdominal ct scan was performed to evaluate the filter.The report that was provided focused solely on the filter and noted a fractured 8 o¿clock strut.Seven images were also provided; in five of those images there is a green arrow pointing to what the physician described as a fractured strut.Scan findings included no caval perforation.Relation of the caval filter the ivc wall is grade 1 consistent with "tenting", no tilting no migration and a fractured filter strut.The product remains implanted and unavailable for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.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.Without images available for review the reported event could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues and comorbidities.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

According to the medical records, the patient was reported to have a history of obesity and pulmonary embolism (pe).The patient presented to the emergency room (er) because of chest pain in the left lower ribcage for two days.A computerized tomography (ct) angiogram of the chest in the er ruled in multiple right-sided pulmonary emboli, basilar interstitial lung changes with atelectasis and small bilateral pleural reactions.The patient was experiencing shortness of breath and was found to have severe anemia.The patient¿s medical history included previous history of pe and deep vein thrombosis (dvt) in the legs, human immunodeficiency virus (hiv) positive, chronic obstructive pulmonary disease (copd), cerebrovascular accident (cva), pleurisy, recurrent urinary tract infection (uti), recurrent cystitis, heavy vaginal bleeding.The surgical history is notable for c-section, neck surgery, appendectomy, back surgery, and knee surgery.Per the implant records the patient presented to the er with chest pain and shortness of breath and was found to have right pulmonary embolism (pe); was severely anemic requiring blood transfusion.The patient had recurrent pe and deep vein thrombosis (dvt) and was wheelchair-bound; therefore, the filter was indicated for further protection.The patient was brought to the cardiac cath; the right groin was infiltrated with xylocaine and then a sheath was inserted to perform a venogram of the inferior vena cava (ivc) to evaluate the position of the renal veins.The ivc filter was applied below the renal veins with good position.The patient tolerated the procedure very well with no significant complication.About four years and eleven months after the filter was implanted, the patient underwent an abdominal ct scan indicated for filter evaluation.The report that was provided focused solely on the filter and noted a fractured 8 o¿clock strut.Seven images were also provided; in five of those images there is a green arrow pointing to what the physician described as a fractured strut.Scan findings included no caval perforation.Relation of the caval filter the ivc wall is grade 1 consistent with "tenting", no tilting no migration and a fractured filter strut.According to the information received in the patient profile form (ppf), the patient reports fractured filter struts retained in the body, becoming aware of these events approximately four years and eleven months after the filter implantation.The patient further asserts to have suffered from anxiety and depression related to the filter.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14842708
• MDR Text Key: 295124061
• Report Number: 9616099-2022-05763
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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 Expiration Date: 02/28/2018
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 17205366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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
• Treatment: UNK LONG 6F SHEATH
• Patient Age: 53 YR
• Patient Sex: Female