MAUDE Adverse Event Report: CORDIS CASHEL TRAPEASE VENA CAVA FILTER

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problems Embolus (1830); Occlusion (1984); No Code Available (3191)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an trapease vena cava filter and for which the catalog and lot numbers are not currently available.  if obtained, a follow up report will be submitted within 30 days upon receipt.As reported in the legal brief (b)(6) vs.Cordis, an unspecified period of time after a trapease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.The product was not returned for analysis.A review of the manufacturing records could not be conducted without a lot number.The trapease 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.Clots, blood clots and occlusion do not represent a device malfunction.The reported events could not be confirmed without films for review.Factors that may have influenced the event include patient, pharmacological and lesion characteristics.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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 in the legal brief (b)(6) vs.Cordis, an unspecified period of time after a trapease vena cava filter was implanted, the filter reportedly malfunctioned causing injury and damages including but not limited to blood clots, clotting and occlusion, of the ivc.As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, which required medical care and treatment.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, blood clots, clotting and occlusion of the inferior vena cava (ivc).The patient also reports to have collateral circulation as a result of the occluded filter and to be suffering from pain, stress and anxiety.The indication for the device implant was left lower extremity deep venous thrombosis (dvt), with recent intra-abdominal hemorrhage status post a hiatal hernia repair, which is a contra-indication to anticoagulation.The patient presented to the hospital eleven days after the hernia surgery with left lower leg edema, dvt was diagnosed.The patient was anticoagulated and developed a retroperitoneal bleed.The device was implanted via the right common femoral vein and deployed below the level of the lowest renal vein.Normal caval anatomy was demonstrated by the inferior venocavography.The device was successfully placed without complications.The patient became aware of the reported issues while still in the hospital, although they are not mentioned in the medical records or the discharge notes.The product was not returned for analysis as it remains implanted and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) 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.The reported blood clots, clotting and occlusion could not be confirmed and could not be further clarified at this time.Blood clots, clotting, and device occlusion related to clotting.Rather, patient and pharmacological factors may have contributed to these events.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).Venous insufficiency and post-thrombotic syndrome do not represent a device malfunction and may be related to underlying patient specific issues.Without the procedural films and post-implant imaging available for review, the reported events and or a device malfunction could be confirmed.Anxiety and bulging veins do not represent a device malfunction and may be related to underlying patient specific issues.With the limited information provided it is not possible to establish a relationship between the reported 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.

Manufacturer Narrative

The following additional information received per the medical records, indicate that the patient has a history of left lower extremity deep vein thrombosis (dvt), intra-abdominal hemorrhage and contraindication to anticoagulation and hernia.The patient had presented to the hospital with swelling of the left leg, retroperitoneal hematoma, anemia and bilateral dvt.During the implantation procedure, the filter was deployed in the lowest renal vein without any complications.According to the patient profile form (ppf), the patient reports to have collateral circulation as a result of an occluded filter and to be suffering from pain, stress and anxiety.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: TRAPEASE VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; miami FL ; EI
• MDR Report Key: 6607808
• MDR Text Key: 76519064
• Report Number: 1016427-2017-00323
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/12/2017
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR