MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PVCF BRACH 90CM CSI; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	466P306BU
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Coagulation Disorder (1779); Stenosis (2263); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Event or Problem 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 specific evidence that the filter had a broken strut and a previously placed right common iliac stent demonstrated approximately 50% stenosis which required treatment with balloon angioplasty.The filter was removed.An 8 french sheath and pigtail catheter were used in an attempt to retrieve the filter, but then required a laser device to be inserted through the right groin and right neck to free up the filter from the inferior vena cava (ivc) wall.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, pain and suffering, and other damages.The medical records indicate that the patient has a history of right leg deep vein thrombosis (dvt), there was some improvement with tpa therapy.The patient had experienced chest pain with acute shortness of breath.The possibility of pulmonary embolism (pe) could not be ruled out.The filter was implanted via the patient's left groin.The filter was deployed at the l2 level without complications.Next, a venogram was performed on the right leg to include the area of the previously treated dvt.There was good flow and resolution of the dvt.The patient tolerated the procedure without complications.Approximately six years and ten months after the index procedure the patient underwent a filter removal procedure, all pieces of the device were removed.Gross description of the explanted device: one arm is broken.However; all pieces of the device were removed.A small amount of red-tan soft tissue was attached to the device.Additional information received per the patient profile form (ppf) states that the patient experienced filter fracture.Approximately six years and ten months after the index procedure the device was removed.The patient reported that they continue to experience pain and blood clots related to the filter.
Additional Manufacturer Narrative
Occupation: other, senior counsel, litigation.Please note that this is the initial report for this product.Additional information is pending and will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received, the following sections have been updated accordingly: b3, b4, d4, g3, g6, h1, h2, h4 and h6.As reported a patient underwent placement of a trapease vena cava filter.The report states that the filter subsequently malfunctioned and caused fracture.There was specific evidence that the filter had a broken strut and a previously placed right common iliac stent demonstrated approximately 50% stenosis which required treatment with balloon angioplasty.The filter was removed.An 8 french sheath and pigtail catheter were used in an attempt to retrieve the filter, but then required a laser device to be inserted through the right groin and right neck to free up the filter from the inferior vena cava (ivc) wall.The patient reported becoming aware of the event approximately six years and ten months post implant, when the filter was removed percutaneously.The patient also reported continuing to experience pain and blood clots related to the filter.According to the medical record the indication for the filter placement was right lower extremity deep vein thrombosis with possible pulmonary embolism.The patient had shortness of breath; the results of a cta angiogram were pending.The patient had undergone tpa therapy with some improvement prior to the filter implant.The filter was placed via the left groin and was deployed at the l2 level without complications.Next, a venogram was performed on the right leg to include the area of the previously treated dvt.There was good flow and resolution of the dvt.The patient tolerated the procedure without complications.Approximately six years and ten months post implant the patient underwent a successful percutaneous removal the filter, from a femoral and right internal jugular (ij) approach, in addition to balloon angioplasty of a right common iliac vein stent.A laser device was used to free the filter from the ivc wall, followed by pushing the groin sheath towards the jugular sheath to collapse the filter, which was then removed through the right ij access site.The filter was sent for pathology, which noted that one arm is broken; however, all pieces of the device appear present.A small amount of red-tan soft tissue was attached to the device.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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe 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, within the device, ivc and/or the vasculature do not represent a device malfunction.Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and vessel characteristics.Stenosis of a previously placed right common iliac stent was reported.The stent manufacturer is unknown at this time.Stenosis is an abnormal narrowing of a vessel, with the limited information provided it is not possible to determine what factors may have contributed to the issue.The instructions for use (ifu) states that filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.Without post implant image reports the reported events could not be confirmed or further clarified.Pain does not represent a device malfunction and may be related to underlying patient specific issues.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 BRACH 90CM CSI
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15446616
• Report Number: 9616099-2022-05989
• Device Sequence Number: 7709184
• Product Code: DTK
• UDI-Device Identifier: 20705032009475
• UDI-Public: 20705032009475
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K020316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: 466P306BU
• Device Catalogue Number: 466P306BU
• Device Lot Number: 15053821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 09/24/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK NEEDLE; UNKNOWN 6 FRENCH DELIVERY SYSTEM; UNKNOWN GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White