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

Model Number 466P306X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Unspecified Infection (1930); Inflammation (1932); Occlusion (1984); Pain (1994); Thrombosis (2100)

Event Date 12/21/2010

Event Type  Injury  

Manufacturer Narrative

The exact implant date is unknown.The catalog number is unknown, if received it will be provided.Complaint conclusion: as reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The indication for filter placement is not available.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis (dvt) and caval thrombosis.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, and pain and suffering, and other damages.The filter remains implanted; thus, unavailable for analysis.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 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, dvt and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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.

Event Description

As reported by the legal department, the patient underwent placement of the trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis and caval thrombosis.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, and pain and suffering, and other damages.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.Additional information received per the medical records indicate that the patient has a history of bipolar disorder, back pain, fever, scattered multiply bilateral pulmonary nodules thought to be septic emboli, deep vein thrombosis, anterior chest pain, a large hiatal hernia and an abdominal cavitary lesion (noted on a computed tomography (ct) scan).The medical records indicated that the filter was implanted due to deep vein thrombosis (dvt) of the right common iliac vein.The filter was placed via the right internal jugular vein and deployed in the infra-renal inferior vena cava.The patient tolerated the procedure well.Approximately one month later, the patient presented with increasing pain to the right lower back and buttock which radiated around to her groin.The patient underwent a ct scan of the abdomen and pelvis and the patient also had a magnetic resonance imaging (mri) scan.The mri revealed extensive inflammation of the right iliopsoas and piriformis muscles and their surrounding soft tissues with associated osteomyelitis of the right sacrum and ilium.The following day, the patient underwent a ct guided right iliacus fluid loculation aspiration and a peripherally inserted central catheter (picc) line was placed.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc), clot in the filter, deep vein thrombosis (dvt), caval thrombosis, mental anguish and the patient was on blood thinners.The patient became aware of the alleged failures approximately six years and six months post implant.Additional information is pending and will be submitted within 30 days of receipt.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly.As reported, the patient underwent placement of the trapease inferior vena cava (ivc) filter.The medical records indicated that the filter was implanted due to deep vein thrombosis (dvt) of the right common iliac vein.The filter was placed via the right internal jugular vein and deployed in the infra-renal inferior vena cava.The patient tolerated the procedure well.Per the medical records, the patient has a history of bipolar disorder, back pain, fever, scattered multiply bilateral pulmonary nodules thought to be septic emboli, deep vein thrombosis, anterior chest pain, a large hiatal hernia and an abdominal cavitary lesion (noted on a computed tomography (ct) scan).The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, deep vein thrombosis and caval thrombosis.Approximately one month after the index procedure, the patient presented with increasing pain in the right lower back and buttock which radiated around to her groin.The patient underwent a ct scan of the abdomen and pelvis and the patient also had a magnetic resonance imaging (mri) scan.The mri revealed extensive inflammation of the right iliopsoas and piriformis muscles and the surrounding soft tissues with associated osteomyelitis of the right sacrum and ilium.The following day, the patient underwent a ct guided right iliacus fluid loculation aspiration and a peripherally inserted central catheter (picc) line was placed.Additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and/or occlusion of the inferior vena cava (ivc), clot in the filter, deep vein thrombosis (dvt), caval thrombosis, mental anguish and the patient was on blood thinners.The filter remains implanted; thus, unavailable for analysis.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 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 occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Anxiety does not represent a device malfunction and may be related to underlying patient related issues.Inflammation, osteomyelitis and pain do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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: UNKNOWN TRAPEASE VENA CAVA FILTER.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer (Section G): CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7432527
• MDR Text Key: 105536031
• Report Number: 1016427-2018-01378
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 466P306X
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 51 YR