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

Catalog Number 466P306X

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Aneurysm (1708); Perforation of Vessels (2135); No Code Available (3191)

Event Date 06/18/2013

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.(b)(4).Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

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, perforation of the inferior vena cava (ivc), fracture of the filter, and complex removal of the filter, but three fractured struts remain embedded in wall of the ivc.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 patient profile form (ppf) indicates that the filter was embedded in the ivc wall and there was also an ivc pseudo aneurysm post the filter removal procedure.The patient underwent the removal attempt ten years and nine months post implantation.The patient also reports to be suffering pain.Per the medical records, the pseudo aneurysm was treated with temporary balloon tamponade.According to the medical records, the patient had brain injury, hemorrhage and pulmonary emboli prior to the filter implantation due to a motor vehicle accident.The filter was successfully deployed below the renal veins and the patient tolerated the index procedure well.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly.It was reported that a patient underwent placement of a trapease vena cava filter.The indication for the placement was brain injury with hemorrhage, subsequent development of a pulmonary embolism (pe) and not a candidate for anti-coagulation therapy.It was reported that the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, perforation of the inferior vena cava (ivc), fracture of the filter, and complex removal of the filter, but three fractured struts remain embedded in wall of the ivc.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.Information contained in the patient profile form revealed that the patient had a computerized tomography (ct) scan approximately ten years after the initial placement, the reason for the evaluation is unknown.The ct images showed a chronically embedded ivc filter.It was determined that the filter was no longer required by the patient and the patient desired to have it removed.Approximately nine months later the patient presented to have the filter removed.Of note, the patient was on xarelto for homozygous factor v leiden, a hereditary hypercoagulable state.The procedural report detailed a difficult removal, incorporating but not limited to the use of a wire loop technique to capture the inferior struts of the filter and the use of a laser sheath to ablate the scar tissue around the filter.The filter was removed, a post removal angiogram revealed a tamponade, a 24mm sizing balloon was inserted and inflated for 5 minutes.An attempt was made to remove a retained strut, but it was reported to be firmly embedded.A repeat venogram was performed and identified some slow filling of the pseudoaneurysm, the balloon was re-introduced and was used to treat the repeat tamponade.According to the patient profile form the patient presented to the hospital approximately four days after the procedure with severe abdominal pain and a ct of the abdomen and pelvis was taken to rule out ivc injury.Post-surgical changes were noted to be seen consistent with interval removal of a previously seen ivc filter; two focal out-pouching's were noted to be seen along the anterior aspect of the ivc approximately 2 cm below the renal veins with surrounding retroperitoneal hemorrhage.These findings were noted to be consistent with ivc pseudoaneurysm with possible ongoing active venous bleeding, the medical records pertaining to this incident were not provided.The patient profile form indicates that the patient also reports to be suffering pain.The filter was successfully deployed during the index procedure below the renal veins and the patient tolerated the index procedure well.The product was not returned for analysis and the sterile lot number has not been provided; therefore, neither a device analysis nor a device history record (dhr) review could be performed.Filter fracture and vessel perforation are known adverse events associated with implanting vena cava filters and are listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.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.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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.Anatomical 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.Review of the information available suggests that the report of embedded may be related to the body¿s natural tendency to endothelialize a foreign object.Strut fracture may be related to certain patient anatomical factors, the reported pseudoaneurysm is most likely related to the procedural factors that were performed during the retrieval procedure, however with the limited information provided it is not possible to determine a root cause for reported events.Anxiety does 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 the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.

• Brand Name: 466P306X
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel, co. tipperary; OH 43017 ; EI 43017
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7071810
• MDR Text Key: 93364408
• Report Number: 1016427-2017-00846
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 466P306X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/03/2017
• Supplement Dates FDA Received: 12/28/2017
• 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): Life Threatening; Required Intervention; Disability
• Patient Age: 28 YR