MAUDE Adverse Event Report: CORDIS CASHEL 466P306X; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 466P306X

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Thrombosis (2100); No Code Available (3191)

Event Date 03/15/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 damages to the patient, including, but not limited to, extensive thrombus of his filter.The patient is reported to experience blood clots, clotting, occlusion of the ivc, pain, and anxiety.The patient¿s medical history is significant for left ankle and left wrist arthroscopic surgery, left inguinal hernia repair, obesity, depression, arthritis, history of prior scopings on knee and chronic knee problems, left hip replacement, hypercholesterolemia, and hypertension.The indication for the filter placement was status post arthroscopic right knee surgery and right deep vein thrombosis (dvt), scheduled for additional surgery on the left knee and in a hypercoagulable state.The filter was placed via the left femoral vein and was seated in the l3-l4 area below the renovascular pedicles.The patient tolerated the procedure well.Approximately one day post implantation of ivc filter, the patient suffered from atypical fleeting chest pain with dizziness and nausea probably secondary to percocet medication administration and anxiety.Approximately four days later, the patient presented with right knee hemarthrosis, swelling, and pain.The patient had a knee aspiration and 110 milliliters of thick bloody fluid removed.Approximately three years and three months post implantation of the ivc filter, the patient presented with lower abdominal pain, nausea, and swelling bilateral lower extremities with extensive dvts in both lower extremities which was diagnosed as the beginning of phlegmasia cerulea dolens.Prior to the admission, the patient had ow back pain and had a massage and stopped taking aspirin at that time as well.The patient was also treated for acute renal failure, probably related to volume depletion as the patient has not been eating well due to having abdominal pain.Approximately two days later, a pelvic venogram and inferior venacavagram were performed and demonstrated a thrombus within and around the ivc trapeze filter, below the filter, and extending to the common femoral veins.Angio-jet mechanical lysis was also performed and there was some improvement but still significant thrombus.Therefore, infusion with pharmacologic lysis was initiated.Following this, the patient underwent several other procedures during this hospital stay including balloon angioplasty of the ivc and common iliac veins, follow up thrombolysis, placement of ivc and bilateral iliac vein stents, an additional iliac vein stent was placed on the right to overlap and treat the area of persistent segmental narrowing, tissue plasminogen activator administration into the clots, mechanical thrombectomy of residual thrombus in the ivc and bilateral iliac veins, and fluoroscopic-guided placement of the an additional unknown ivc filter at the level of renal vein flow due to having the previous ivc filter occluded.Additionally, during this hospital visit the patient was treated with antibiotics for a fever.According to the information received in the patient profile from (ppf), the patient became aware the alleged events approximately on or about three years and three months post implantation of the ivc filter.There is currently no additional information available.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.A device malfunction has not been reported at this time.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.Phlegmasia cerulea dolens is an uncommon severe form of deep vein thrombosis (dvt) resulting from extensive thrombotic occlusion.Post-thrombotic syndrome (pts) is a problem that can develop in nearly half of all patients who experience a deep vein thrombosis (blood clot) in the leg.Pts symptoms include chronic leg pain, swelling, redness, and ulcers (sores).Anxiety, pain, nausea, fever and acute renal do not represent a device malfunction and may be related to underlying patient specific issues.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.

Event Description

As reported by the legal brief, 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, extensive thrombus of his filter.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 following additional information received per the medical records indicate that the patient underwent placement of the inferior vena cava (ivc) due to their history of right knee surgery with deep venous thrombosis (dvt) of the right leg and pending further surgery of the lower extremity and hypercoagulable state.The patient also has a history of left ankle and left wrist arthroscopic surgery, left inguinal hernia repair, obesity, depression, arthritis, history of prior scopings on knee and chronic knee problems, left hip replacement, hypercholesterolemia, and hypertension.During the placement of ivc via the left femoral vein, the filter was seated in the l3-l4 area below the renovascular pedicles.The patient tolerated the procedure well.Approximately on or about one day post implantation of ivc filter, the patient suffered from atypical fleeting chest pain with dizziness and nausea probably secondary to percocet medication administration and anxiety.Approximately four days later, patient present with right knee hemarthrosis, swelling, and pain.The patient had a knee aspiration and 110 milliliters of thick bloody fluid removed.Approximately on or about three years and three months post implantation of the ivc filter, the patient presented with lower abdominal pain, nausea, and swelling bilateral lower extremities with extensive dvts in both lower extremities which was diagnosed as the beginning of phlegmasia cerulea dolens.The patient was also treated for acute renal failure, probably related to volume depletion as the patient has not been eating well due to having abdominal pain.Approximately two days later, a pelvic venogram and inferior venacavagram were performed and demonstrated a thrombus within and around the ivc trapeze filter, below the filter, and extending to the common femoral veins.Angio-jet mechanical lysis was also performed and there was some improvement but still significant thrombus.Therefore, infusion with pharmacologic lysis was initiated.Following this, the patient underwent several other procedures during this hospital stay including balloon angioplasty of the ivc and common iliac veins, follow up thrombolysis, placement of ivc and bilateral iliac vein stents, an additional iliac vein stent was placed on the right to overlap and treat the area of persistent segmental narrowing, tissue plasminogen activator administration into the clots, mechanical thrombectomy of residual thrombus in the ivc and bilateral iliac veins, and fluoroscopic-guided placement of the an additional unknown ivc filter at the level of renal vein flow due to having the previous ivc filter occluded.There was no known attempt to remove first ivc filter placed.The patient tolerated all the described procedures well and with no complications.Additionally, during this hospital visit the patient was treated with antibiotics for a fever.According to the information received in the patient profile from (ppf), the patient became aware the alleged events three years and three months post implantation of the ivc filter.The patient reports to suffer from blood clots, clotting, occlusion of the ivc, continued pain, and anxiety.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir rad; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7536670
• MDR Text Key: 108999711
• Report Number: 1016427-2018-01480
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention; Disability
• Patient Age: 49 YR