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CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number 466FXXXX |
| Device Problems
Difficult to Remove (1528); Unintended Movement (3026); Migration (4003)
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| Patient Problems
Internal Organ Perforation (1987); Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
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| Event Date 09/26/2017 |
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Event Type
Injury
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Manufacturer Narrative
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Occupation: other, senior counsel, litigation.Please note that the exact event date is unknown and the event date is the complaint awareness date.As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter tilted, potentially migrated and become embedded.In addition, the patient reported that they had undergone multiple failed attempts to retrieve the filter.Details related to these retrieval attempts were not documented.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, migration, device embedment 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.Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (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 ivc 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.The predominant concern for embedding within the wall of the ivc is the development of endothelialization.Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures.The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation.Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.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.Please note that this is the initial report for this product.
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Event Description
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As reported by the legal brief, the patient underwent placement of an optease vena cava filter.The report states that the filter subsequently malfunctioned and caused injury and damage to the patient including, but not limited to multiple failed removal attempts due to perforated, tilted, embedded and potentially migrated inferior vena cava (ivc) filter.
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Manufacturer Narrative
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As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused multiple failed removal attempts due to perforated, tilted, embedded and potentially migrated inferior vena cava (ivc) filter.The patient reported becoming aware of perforation of filter struts, tilt, embedded and the device unable to be retrieved during a percutaneous removal procedure approximately six months after the index procedure.The patient also reported fear related to the filter.According to the medical record the patient¿s history is notable for peripheral artery disease, chronic kidney disease, hypertension, hyperlipidemia, osteoarthritis, psoriasis, obesity, endometrial cancer, deep vein thrombosis (dvt), intestinal obstruction, peptic ulcer, pseudopolyposis of colon, tobacco use and chronic obstructive pulmonary disease.Surgical history of back, knee, carpal tunnel, hysterectomy, appendectomy and tonsillectomy.The indication for the filter placement was left lower extremity (lle) dvt involving the left common femoral, superficial femoral, peroneal and post tibial veins.The patient underwent a lumbar fusion approximately six weeks prior to the filter placement and was undergoing rehabilitation when they developed lower extremity pain and swelling.An ultrasound (u/s) showed dvt of the entire lle.The filter was placed via the right common femoral vein and deployed in the suprarenal portion of inferior vena cava due to the presence of the thrombosis within the infrarenal section of the inferior vena cava.Following placement, the patient underwent transcatheter tissue plasminogen activator (tpa) thrombolytic infusion into the lle deep veins.Electrocardiogram (ekg) changes occurred during the thrombectomy procedure.The patient was evaluated for the abnormal ekg.(a nuclear stress test was performed approximately one month and two weeks post implant, the results were normal.) the day after the index procedure, despite transcatheter tpa thrombolysis infusion and transcatheter thrombectomy with the penumbra catheter, it was not possible to clear the clot of the left iliofemoral veins.There were significant collateral veins throughout the left thigh and pelvis that suggests that there was a significant amount of chronicity to the thrombus.After multiple attempts, the procedure was terminated without achieving complete success of declotting the left iliofemoral veins.Three weeks post implant the patient underwent a u/s of the lle.The results noted persistent thrombus in the left common femoral, superficial femoral and popliteal veins, corresponding to previous findings of three days after the index procedure.Three months after the index procedure the patient underwent a u/s of lle for persistent edema.The finding revealed persistent thrombosis of the left common femoral, superficial femoral and popliteal veins with minimal improvement noted.The left posterior tibial, peroneal and great saphenous veins remain patent and free of thrombosis.Approximately six months post implant there was an unsuccessful percutaneous retrieval attempt.It was noted that the patient no longer needed the filter.Access was made via the right common femoral vein.A venogram demonstrated no evidence of significant thrombus; however, the filter appeared to extend beyond the walls and was likely embedded.Multiple attempts at removing the filter were performed using a snare device and launch sheath; however, despite filter capture, the superior margin of the filter appeared embedded within the ivc wall and was unable to be removed.The procedure was aborted.Upon completion of the exam, the filter was intact without evidence of migration.Approximately two years and eleven months post implant an abdominal computed tomography (ct) scan was performed, the images were submitted for independent review approximately three years and six months post implant, with sole focus on the filter.The report indicated that the filter was tilted with the apex against the wall, 3 mm mesenteric perforation.The distal portion of the filter was at the level of the right renal vein and the left renal vein enters at approximately the midbody of the filter.This may represent migration.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling.The predominant concern is the development of endothelialization, which would make subsequent removal difficult.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.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 does 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.
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Event Description
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Additional information received per the patient profile form (ppf) states that the patient experienced perforation of filter struts outside the ivc, filter tilt, filter embedded in wall of the ivc and the device was unable to be retrieved during a percutaneous removal procedure approximately six months after the index procedure.The patient continues to experience fear related to the filter.Additional information received per the medical records indicate that the patient has a history of peripheral artery disease, chronic kidney disease, hypertension, hyperlipidemia, osteoarthritis, psoriasis, obesity, endometrial cancer, deep vein thrombosis (dvt), intestinal obstruction, peptic ulcer, pseudopolyposis of colon, tobacco use and chronic obstructive pulmonary disease (copd).The patient has a surgical history of back, knee, carpal tunnel, hysterectomy, appendectomy and tonsillectomy.The indication for the filter placement was left lower extremity (lle) deep vein thrombosis (dvt) involving the left common femoral, superficial femoral, peroneal and post tibial veins.The patient underwent a lumbar fusion approximately six weeks prior to the filter placement and was undergoing rehabilitation when they developed lower extremity pain and swelling.An ultrasound (u/s) showed dvt of the entire lle.The filter was deployed via the patient's right common femoral vein.The filter was placed in the suprarenal portion of inferior vena cava due to the presence of the thrombosis within the infrarenal section of the inferior vena cava.This represented a significant risk to the patient for pulmonary embolism.Following filter placement, the patient underwent transcatheter tissue plasminogen activator (tpa) thrombolytic infusion into the left lower extremity deep veins.Electrocardiogram (ekg) changes occurred during the thrombectomy, during this hospitalization.The patient was evaluated for the abnormal ekg.(the patient underwent a nuclear stress test approximately one month and two weeks after the index procedure to further investigate, the results were normal.) the day after the index procedure, despite transcatheter tpa thrombolysis infusion and transcatheter thrombectomy with the penumbra catheter, it was not possible to clear the clot of the left iliofemoral veins.There were significant collateral veins throughout the left thigh and pelvis that suggests that there was a significant amount of chronicity to the thrombus.After multiple attempts, the procedure was terminated without achieving complete success to the declotting of the left iliofemoral veins.Three weeks after the index procedure the patient underwent an u/s of the lle.The results noted persistent thrombus in the left common femoral vein, superficial femoral vein and popliteal vein, corresponding to previous findings of three days after the index procedure.Three months after the index procedure the patient underwent an u/s of lle for persistent edema.The finding revealed persistent thrombosis of the left common femoral, superficial femoral and popliteal veins with minimal improvement noted.The left posterior tibial, peroneal and great saphenous veins remain patent and free of thrombosis.Approximately six months after the index procedure there was an unsuccessful percutaneous retrieval attempt.It was noted that the patient no longer needed the filter.Access was made via the right common femoral vein.A venogram was performed which demonstrated no evidence of significant thrombus; however, the filter appeared to extend beyond the walls and was likely embedded.Multiple attempts at removing the filter were performed using a snare device and launch sheath; however, despite filter capture, the superior margin of the filter appeared embedded within the ivc wall and was unable to be removed.The procedure was aborted.Upon completion of the exam, the filter was intact without evidence of migration.Approximately two years and eleven months after the index procedure an abdominal computed tomography (ct) scan was performed.Approximately three years and six months after the index procedure this abdominal scan was reviewed with focus on the filter.The radiology report indicated that the filter was tilted with the apex against the wall, 3 mm mesenteric perforation.The distal portion of the filter was at the level of the right renal vein and the left renal vein enters at approximately the midbody of the filter.This may represent migration.Posterior spinal fusion was noted with degenerative disc disease, atherosclerosis of the aorta and cholelithiasis (gallstones).
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