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

Model Number	466F220A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135)
Date of Event	07/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to filter fracture and perforation.As a direct and proximate result of these malfunctions, 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.
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Date of event: please note that the exact event date is unknown and the event date is the complaint awareness date.It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter fracture and perforation.The indication for the filter placement, procedural details and medical history of the patient have not been provided.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 trapease 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.The instructions for use (ifu) states 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.A review of the ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant images 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.Please note that this is the initial report for this product.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: a2, b3, b4, b5, b7, d1, d4, d10, g2, g3, g6, h1, h2, h4 and h6.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.Additional information is pending and will be submitted within 30 days of receipt.
Event or Problem Description
Additional information received per the medical records state that the patient was admitted to the hospital with massive bilateral pulmonary embolism with large saddle embolus and distal right lower extremity deep vein thrombosis.The filter was implanted via the patient's right internal jugular vein.The filter was deployed into the infrarenal area of the inferior vena cava.A right pulmonary arteriogram revealed saddle embolus with extensive occlusive emboli throughout the middle and lower lobes.An infusion catheter was placed within the inferior division of right pulmonary artery.The patient tolerated the procedure well.The patient was then transferred back to icu for thrombolytic infusion.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture within the inferior vena cava and perforation of filter struts outside the inferior vena cava.The patient became aware of the reported events approximately nine years and two months after the index procedure.The patient reported that they also experienced pain (abdomen, lower back and breast), stress and heart palpitation.
Additional Manufacturer Narrative
It was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter fracture and perforation.The patient reported becoming aware of the events approximately nine y ears and two months post implant.The patient also reported lower back, breast and abdominal pain, anxiety and palpitations related to the filter.According to the medical record the patient had a history of deep vein thrombosis (dvt), approximately four years prior to implant.The indication for the filter implant was massive bilateral pulmonary embolism with large saddle embolus and distal right lower extremity dvt.The filter was implanted via the right internal jugular vein and deployed into the infrarenal area of the inferior vena cava.A right pulmonary arteriogram revealed saddle embolus with extensive occlusive emboli throughout the middle and lower lobes.An infusion catheter was placed within the inferior division of right pulmonary artery.The patient tolerated the procedure well.The patient was then transferred back to icu for thrombolytic infusion.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 trapease 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.The instructions for use (ifu) states 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.A review of the ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without procedural films or post implant images for review the reported events could not be confirmed or further clarified.Palpitations, pain and stress do not represent a device malfunction and may be related to underlying patient specific issues or other undisclosed comorbidities.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: OPTEASE RETRIEVAL FILTER
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15279312
• Report Number: 9616099-2022-05917
• Device Sequence Number: 20588262
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15830469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 12/05/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 12/01/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 6-FRENCH PIGTAIL CATHETER.; UNKNOWN 7-FRENCH FILTER DELIVERY SHEATH.; UNKNOWN CATHETER SHEATH.; UNKNOWN GUIDEWIRE.; UNKNOWN SHORT 7-FRENCH SHEATH.; UNKNOWN.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR
• Patient Sex: Female