MAUDE Adverse Event Report: CORDIS CASHEL UNKNOWN TRAPEASE VENA CAVA FILTER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 466P306X

Device Problems Difficult to Remove (1528); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984)

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the exact event date is unknown and that the event date is the complaint awareness date.Occupation: other, senior counsel, litigation.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 injury and damage to the patient including, but not limited to filter embedded in wall of inferior vena cava, blood clots, clotting and occlusion of the inferior vena cava.The information also indicated that the device was unable to be retrieved; however, documentation of any retrieval attempts has 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 trapease 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.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The predominant concern for embedding with in 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.Endothelialization has been shown to lead to explantation problems after as short a period as 12 days.Without images or procedural films for review the reported embedded could not be confirmed or further clarified.As the patient¿s medical history has not been provided, it is not possible to determine a relationship between the events and the device.Given the limited information currently 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/final report for this product.

Event 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 embedded in wall of inferior vena cava, blood clots, clotting and occlusion of the inferior vena cava.The legal brief also states that the device was unable to be retrieved; however, no documentation of retrieval attempts were provided.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: date of report, pma/510k, type of reportable event and if follow.Event: it was reported that a patient underwent placement of a trapease vena cava filter.The information provided indicated that the filter tilted and was embedded and the patient experienced blood clots, clotting and occlusion of the inferior vena cava, pain, swelling of legs/feet from multiple clots and occlusion at the filter.The patient also experienced stress and anxiety and numerous unspecified medical procedures to treat occlusion of the filter.Information contained in the medical records indicated that the filter was placed due to bilateral pulmonary embolism with residual lower extremity deep vein thrombosis (dvt).The filter was placed via the right femoral vein and deployed below the level of the renal veins.A pre-deployment venacavogram demonstrated no intra caval thrombus or variant in caval anatomy.The patient tolerated the procedure well.The patient¿s medical history, prior to implant, was significant for coronary artery by-pass surgery, chronic hip pan, gout, benign prostatic hyperplasia, insomnia, morbid obesity, bilateral hearing loss and hypertension and bilateral total hip replacements.Approximately ten months and two weeks after the index procedure, there was an evaluation of the filter and unsuccessful attempt to remove the device.A bilateral femoral approach was made, a contrast injection was made, and the proximal filter hook was noted to be embedded in the wall of the ivc and residual thrombus was noted in the distal ivc filter.Access to the removal hook could not be achieved, the filter was not removed.Approximately two years and three months after the index procedure, the patient presented to the hospital with bilateral lower extremity weakness with associated numbness.The patient also became lightheaded and dizzy, nauseated and diaphoretic with the bilateral lower extremity weakness with any type of exertion, standing or walking.The patient had undergone radiofrequency ablation of the lumbar facets on two separate occasions the month prior.A computed tomography (ct) scan of the abdomen and pelvis was performed and showed a stable partially calcified mass in the right iliacus muscle and a new abnormal hypodense expansion of the left iliacus muscle.A magnetic resonant imaging (mri) scan was performed of the lumbar spine and showed degenerative changes in the lumbar spine.A ct of the head showed no acute intracranial pathology.The patient was diagnosed with acute kidney injury and acute cystitis.A scan performed during this hospitalization showed acute, extensive dvt of the left popliteal, common femoral and superficial veins.An ultrasound of the right lower extremity was performed and showed no evidence of right sided dvt.Subsequently, the patient underwent a venocavogram and ilio-pelvic angiography with thrombolysis for acute onset of left lower extremity dvt.Subtraction angiogram showed patent superficial venous system all the way up to the common femoral region, it was occluded at that point.A guidewire was passed through the clotted iliac system and imaging was performed through the filter, which was noted to be occluded.Tissue plasminogen activator (tpa) was infused through the entire vena cava and right and left iliac systems.A penumbra device was used to remove large volume of clot from the right common femoral vessel; however, the left clot was unable to be removed as evidence of its probable chronic nature.The procedure was aborted due to the acute kidney injury.The patient reportedly tolerated the procedure without complication.The discharge notes indicated that the patient has extensive dvt and had a failed thrombolysis.The clot was noted to be so large that there was a huge burden on the ivc down to both iliac veins.The notes indicated that the ivc filter showed no evidence of being plugged; however, other medical transcription notes indicated that the filter is occluded.It was also noted that the patient has a renal mass.Physician notes indicate that the patient has a swollen right extremity and lymphatic drainage out of the left leg and is in the category of post-phlebitic lymphedema.Two years and nine months after the index procedure the patient was seen by the physician for some urinary clot and bleeding, it was recommended that the patient see a urologist and be taken off eliquis.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 trapease 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.Blood clots, clotting, and device occlusion related to clotting do not indicate a device malfunction.Rather, patient and pharmacological factors may have contributed to these events.The predominant concern for embedding with in 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.Endothelialization has been shown to lead to explant problems after as short a period as 12 days.Without images or procedural films for review, the reported filter tilt could not be confirmed, and the exact causes could not be determined.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.The medical records do not mention tilt of the filter and the timing and the mechanism of the filter tilt is unknown.Pain, anxiety, leg numbness, weakness, light-headedness, dizziness, nausea and diaphoresis do not represent a device malfunction and may be related to underlying patient specific issues that are occurring at any given time.At the time of these events the patient was diagnosed with acute kidney injury and acute cystitis.Given the limited information currently 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.

Manufacturer Narrative

Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary blood clots, pulmonary embolus with residual lower extremity deep vein thrombosis (dvt).The patient¿s medical history, prior to the implant, was significant for coronary artery by-pass surgery, chronic hip pan, gout, benign prostatic hyperplasia, insomnia, morbid obesity, bilateral hearing loss and hypertension.The patient had bilateral total hips replacements seventeen years before the index procedure.The filter was deployed via the right femoral vein.It was placed below the level of the renal veins.There were no complications.The patient tolerated the procedure well.Approximately two years and three months after the index procedure, the patient presented to the hospital with bilateral lower extremity weakness with associated numbness.The patient also became lightheaded and dizzy, nauseated and diaphoretic with the bilateral lower extremity weakness with any type of exertion, standing or walking.The patient had undergone radiofrequency ablation of the lumbar facets on two separate occasions the month prior.A computed tomography (ct) scan of the abdomen and pelvis was performed and showed a stable partially calcified mass in the right iliacus muscle and a new abnormal hypodense expansion of the left iliacus muscle.A magnetic resonant imaging (mri) scan was performed of the lumbar spine and showed degenerative changes in the lumbar spine.A ct of the head showed no acute intracranial pathology.The patient was diagnosed with acute kidney injury and acute cystitis.A scan performed during this hospitalization showed acute, extensive dvt of the left popliteal, common femoral and superficial veins.An ultrasound of the right lower extremity was performed and showed no evidence of right sided dvt.Subsequently, the patient underwent a venocavogram and ilio-pelvic angiography with thrombolysis for acute onset of left lower extremity dvt.Subtraction angiogram showed patent superficial venous system all the way up to the common femoral region, it was occluded at that point.A guidewire was passed through the clotted iliac system and imaging was performed through the filter, which was noted to be occluded.Tissue plasminogen activator (tpa) was infused through the entire vena cava and right and left iliac systems.A penumbra device was used to remove large volume of clot from the right common femoral vessel; however, the left clot was unable to be removed as evidence of its probable chronic nature.The procedure was aborted due to the acute kidney injury.The patient reportedly tolerated the procedure without complication.The discharge notes indicated that the patient has extensive dvt and had a failed thrombolysis.The clot was noted to be so large that there was a huge burden on the ivc down to both iliac veins.The notes indicated that the ivc filter showed no evidence of being plugged; however, other medical transcription notes indicated that the filter is occluded.It was also noted that the patient has a renal mass.Physician notes indicate that the patient has a swollen right extremity and lymphatic drainage out of the left leg and is in the category of post-phlebitic lymphedema  two years and nine months after the index procedure the patient was seen by the physician for some urinary clot and bleeding, it was recommended that the patient see a urologist and be taken off eliquis. additional information received per the patient profile form (ppf) states that the patient experienced filter tilting, filter embedded in the wall of inferior vena cava (ivc), blood clots, clotting and/or occlusion of the ivc.The form states that the device was unable to be retrieved.Ten months and two weeks after the index procedure, there was an unsuccessful attempt to remove the device.The patient also experienced pain, swelling of legs/feet from multiple clots and occlusion at the filter.The patient also experienced stress and anxiety and numerous unspecified medical procedures to treat occlusion of the filter.The patient became aware of the clotting and embedment approximately ten months post implantation.The initial legal brief and multiple medical records state that the implanted device is a trapease filter.The ppf states that an optease filter was implanted.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.Additional information is pending and will be submitted within 30 days of receipt.

• Brand Name: UNKNOWN TRAPEASE VENA CAVA FILTER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co. tipperary; EI
• MDR Report Key: 8090465
• MDR Text Key: 127925677
• Report Number: 1016427-2018-02286
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2019
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 04/01/2019; 05/04/2019
• Supplement Dates FDA Received: 04/30/2019; 05/24/2019
• Patient Sequence Number: 1
• Treatment: UNK.; UNKNOWN 6 FRENCH SHEATH.; UNKNOWN GUIDE WIRE.
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 73 YR