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

Catalog Number 466P306AU

Device Problem Migration or Expulsion of Device (1395)

Patient Problems No Consequences Or Impact To Patient (2199); Anxiety (2328); Foreign Body In Patient (2687)

Event Date 11/06/2014

Event Type  Injury  

Manufacturer Narrative

This report is a follow up report to mfr number 9616099-2016-00277 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported in the legal brief, the patient underwent placement of a trapease intra vena cava (ivc) filter on or about (b)(6) 2014.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, migration of the 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 patient profile form indicates that the patient continues to experience depression, stress and anxiety which is being treated by prescription; lower chest and upper abdominal pain; burning sensation under the sternum when picking up something; insomnia/lack of sleep because of discomfort.The medical records indicate that the index procedure was performed as a treatment for bilateral pulmonary emboli, and bilateral lower extremity deep vein thrombosis.The medical records indicate that the index procedure was tolerated well.

Manufacturer Narrative

It was reported that a patient underwent placement of a trapease intra vena cava (ivc) filter for bilateral lower extremity deep vein thrombosis (dvt) and bilateral pulmonary emboli.Approximately eleven months post implant the patient became aware that the filter had migrated.It is unknown how the patient became aware of the reported filter migration.According to the information received ¿the filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to, migration of the 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.¿ according to the information received on the patient profile form the patient continues to experience depression, stress and anxiety which is being treated by prescription medication; lower chest and upper abdominal pain; burning sensation under the sternum when picking up something; insomnia/lack of sleep because of discomfort.The medical records indicate that the index procedure was tolerated well.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 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.Without images or procedural films for review, the reported filter migration could not be confirmed and the exact cause could not be determined.Inferior vena cava (ivc) filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the instruction for use (ifu) as such.Possible causes for filter migration includes mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error.Physiologic causes of migration may result from temporary dysmorphism of the inferior vena cava including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter.Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters.Pain, anxiety and insomnia 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 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: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CASHEL; cahir road; 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: 7052034
• MDR Text Key: 92722597
• Report Number: 1016427-2017-00762
• 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: 12/04/2017

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 Expiration Date: 05/31/2017
• Device Catalogue Number: 466P306AU
• Device Lot Number: 17043371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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; Disability
• Patient Age: 51 YR