MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE PVCF FEM/JUG 55CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306AU

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

Patient Problems Embolus (1830); Occlusion (1984); Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 06/09/2019

Event Type  Injury  

Manufacturer Narrative

The catalog number is unknown, if received it will be provided.As reported, the patient underwent placement of the trapease inferior vena cava 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, complete thrombosis of the inferior vena cava (ivc).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 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, complete thrombosis of the inferior vena cava (ivc).As a direct and proximate result, 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.

Event Description

Additional information received per the medical records indicate that the patient has a history of allergy to motrin (hives), myocardial infarction, deep venous thrombosis, embolism, previous back surgery, quad bypass/cardiac catherization, orthopedic surgery.The medical records state that the patient has a history of smoking, myocardial infarction and tonsillectomy.Twenty-three years before the index procedure, the patient sustained a traumatic injury of the cervical and lumbar spine with subsequent c5-c6 fusion and l5-s1 discectomy.This trauma was further complicated by deep vein thrombosis (dvt) of the right leg that extended into the right iliac vein.Since that time, the patient has had multiple recurrent episodes of dvt and thrombophlebitis despite intermittent anticoagulation treatment.The medical records also noted that the patient has stopped taking his anticoagulation treatment on occasion for financial reasons.Two days before the index procedure, the patient was admitted to hospital with acute onset of pain and spasm involving the entire right leg.Diagnostic testing revealed extensive thrombus in the right common and superficial femoral veins.The patient was further noted to have been on anticoagulation treatment with a therapeutic inr at the time of presentation.The patient underwent placement of a trapease vena cava filter for possibility of dvt despite anticoagulation treatment and for concerns about possible future interruptions in anticoagulation treatment therapy.The filter was implanted via the left femoral vein and placed at the upper end of l2 level without difficulty.Approximately ten years, nine months and two weeks after the index procedure, the patient underwent a computed tomography (ct) scan that revealed an area suspicious for chronic inferior vena cava (ivc) thrombosis with extensive subcutaneous collaterals below the level of the filter.The study further noted questionable bowel wall thickening involving the stomach/duodenum.The patient opted to leave hospital against medical advice at that time.The next day, the patient again presented to hospital with non-specific chronic abdominal pain and bloating that had worsened over the previous two weeks.The patient was also noted to have high blood pressure when initially evaluated.Since the patient declined admission, a recommendation for outpatient colonoscopy and endoscopy.The patient was discharged later that day. additional information received per the patient profile form (ppf) states that the patient experienced blood clots, clotting and/or occlusion of the ivc and that the device was irretrievable.Attempts to retrieve the filter were not documented.The patient became aware of the reported events approximately eight years and four months after the index procedure.The patient has also experienced complete thrombosis of the ivc, occlusion of the ivc and mental anguish.

Manufacturer Narrative

After further review of additional information received, the following sections have been updated accordingly: a2, a5, b3, b4, b5, b6, b7, d1, d4, g3, g4, g7, h1, h2, h4 and h6.Section h6: patient code '2572' was used for 'extensive subcutaneous collaterals'.Continuation of section b5: as reported, the patient had placement of the trapease inferior vena cava (ivc) filter.Per the medical records, history includes smoking, myocardial infarction and tonsillectomy.Twenty-three years before the index procedure, the patient sustained a traumatic injury of the cervical and lumbar spine with subsequent c5-c6 fusion and l5-s1 discectomy, complicated by deep vein thrombosis (dvt) of the right leg that extended into the right iliac vein.Since that time, the patient has had multiple recurrent episodes of dvt and thrombophlebitis despite intermittent anticoagulation treatment.Two days before the index procedure, the patient was admitted to hospital with acute onset of pain and spasm involving the entire right leg.Imaging revealed extensive thrombus in the right common and superficial femoral veins while on anticoagulation treatment with a therapeutic inr at the time of presentation.The filter was implanted via the left femoral vein and placed at the upper end of l2 level without difficulty.The filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, complete thrombosis of the inferior vena cava (ivc).Approximately 11 years after the index procedure, a ct scan revealed chronic inferior vena cava (ivc) thrombosis with extensive subcutaneous collaterals below the level of the filter.The study further noted questionable bowel wall thickening involving the stomach/duodenum.The patient opted to leave hospital against medical advice at that time.The next day, the patient again presented to hospital with non-specific chronic abdominal pain and bloating that had worsened over the previous two weeks.The patient was also noted to have high blood pressure when initially evaluated.Since the patient declined admission, a recommendation for outpatient colonoscopy and endoscopy.The patient was discharged later that day.Per the patient profile form (ppf), the patient reports blood clots, clotting and/or occlusion of the ivc and that the device was irretrievable.Attempts to retrieve the filter were not documented.The patient also reports anxiety.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 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 and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Collateral circulation, anxiety 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: TRAPEASE PVCF FEM/JUG 55CM CSI
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8736394
• MDR Text Key: 149250321
• Report Number: 1016427-2019-03003
• Device Sequence Number: 1
• Product Code: DTK
• 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
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466P306AU
• Device Lot Number: R0508393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR