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

Model Number	466F220A
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2015
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 specific evidence that the filter broke, became fragmented and migrated to the right groin.This required fluoroscopically assisted surgery with 3-4 inch incisions to remove the foreign body from the patient's right upper thigh.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 information received per the medical records indicate that the patient has a history of morbid obesity with increased propensity for deep vein thrombosis and pulmonary emboli.The filter was placed prophylactically for gastric bypass procedure.The filter was implanted via the patient's right common femoral vein.The filter was deployed using direct fluoroscopic guidance.There was no evidence of migration of the filter upon removal of the introducing catheter.The patient was in satisfactory condition after the procedure.Approximately six years post implant a computed tomography (ct) scan was performed to evaluate the filter.Results of the scan noted that the inferior vena cava (ivc) filter was not within the abdomen or pelvis.However, there were linear metallic densities compatible with a broken filter in the right groin.The tip of the filter appeared to be just beneath the skin, which accounted for the palpable abnormality.The filter did not appear to be within any major vessel.It was just anterior to branches of the superficial femoral vein.Approximately six years and three months post implant the patient underwent a fluoroscopically assisted removal of filter from their right medial upper thigh.An incision was made at the palpable head of the ivc filter.The filter was densely adherent to the tissue.The filter was dissected free and removed.Palpation confirmed some struts were still present and these were also dissected out and removed.Additional pieces were present.Fluoroscopic guidance was used to remove the remaining pieces.It required an incision approximately 3-4 inches in length overall.A final fluoroscopy confirmed the absence of any remaining filter pieces.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture, perforation of filter strut(s) outside the inferior vena cava (ivc) and filter embedded in wall of the ivc.The patient became aware of the reported events approximately six years after the index procedure.Although the filter was removed, the patient reported that they continue to experience chest pain and swelling.
Additional Manufacturer Narrative
Initial reporter occupation: other, senior counsel, litigation.It was reported that a patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned, the filter broke, became fragmented and migrated to the right groin.This required fluoroscopically assisted surgery with 3¿4-inch incisions to remove the foreign body from the patient's right upper thigh.The patient reported becoming aware of filter fracture, perforation and embedded, approximately six years post implant.The patient also reported experiencing chest pain and swelling.According to the medical record the indication for the implant was prophylactically prior to gastric bypass in morbidly obese patient with increased propensity for deep vein thrombosis and pulmonary emboli.The filter was placed via the right common femoral vein and deployed using direct fluoroscopic guidance.There was no evidence of migration of the filter upon removal of the introducing catheter.The patient was in satisfactory condition after the procedure.Approximately six years post implant a computed tomography (ct) scan was performed to evaluate the filter.The patient was status post gastric bypass surgery and reported feeling that the filter is protruding through the skin of the right thigh or groin.Results of the scan noted that the filter was not within the abdomen or pelvis.However, there were linear metallic densities compatible with a broken filter in the right groin.The tip of the filter appeared to be just beneath the skin, which accounted for the palpable abnormality.The filter did not appear to be within any major vessel.It was just anterior to branches of the superficial femoral vein.Approximately three months later the patient underwent a fluoroscopically assisted removal of filter from the right medial upper thigh.An incision was made at the palpable head of the ivc filter.The filter was densely adherent to the tissue.The filter was dissected free and removed.Palpation confirmed some struts were still present and these were also dissected out and removed.Additional pieces were present.Fluoroscopic guidance was used to remove the remaining pieces.It required an incision approximately 3-4 inches in length overall.A final fluoroscopy confirmed the absence of any remaining filter pieces.The product was not returned 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 ivc 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.Endothelialization refers to the process in which endothelial tissue is formed.This is the normal process whereby the body heals and recovers from invasive procedures or forms a protective shell around a foreign object.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 notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The ifu also 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.Ivc filter and or strut 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.The timing and mechanism of the events is unknown, and a clinical conclusion could not be determined as to the cause of the event.Without procedural films available for review a definitive cause for the filter being found in the groin could not be determined.Chest pain and swelling do not represent a device malfunction and may be related to underlying patient specific issues and comorbidities.There is nothing to suggest that the reported event is related to the design and/or 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.

• 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: 15435425
• Report Number: 9616099-2022-05978
• Device Sequence Number: 5673218
• 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: K034050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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 Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1108128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 09/16/2022
• Date Device Manufactured: 11/11/2008
• 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 16 GAUGE NEEDLE; UNKNOWN GUIDE WIRE; UNKNOWN INTRODUCING CATHETER
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male