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

Catalog Number 466P306AU

Device Problem Unintended Movement (3026)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Ventricular Fibrillation (2130)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.This report is a follow up report to mfr number 9616099-2016-00298 that was submitted under the previous complaint handling software system.The information has been duplicated from the first report with additional information added.

Event Description

As reported by the legal brief, after an unspecified period of time when a trapease vena cava filter was implanted, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, migration of the filter to heart requiring emergency open-heart surgery.The following additional information received per the medical records indicates, after an unspecified time post implantation, the patient had severe pain, pulmonary embolism (pe), deep vein thrombosis (dvt) and premature ventricular contractions.On or about twenty days post implantation, the filter was removed via an open chest procedure.Originally prior to the filter implantation, the patient had a history of dvt, pe and subdural hematoma.The coumadin had been recently discontinued therefore the filter was placed on an emergency basis to protect against pe.The filter was placed on the l2-3 interspace.The patient tolerated the index procedure well and had no complications.Upon discharge the patient had a diagnosis of chronic pain and was being treated with medication.

Manufacturer Narrative

As reported, at an unknown time after implantation of a trapease vena cava filter, the filter subsequently malfunctioned and caused injury and damages to the patient including, but not limited to, migration of the filter to heart requiring emergency open-heart surgery.The indication for filter implantation was a history of dvt, pe and subdural hematoma.The coumadin had been recently discontinued therefore the filter was placed on an emergency basis to protect against pe.The filter was placed on the l2-3 interspace.The patient tolerated the index procedure well and had no complications.Upon discharge the patient had a diagnosis of chronic pain and was being treated with medication.Per the medical records, after an unspecified time post implantation, the patient had severe pain, pulmonary embolism (pe), deep vein thrombosis (dvt) and premature ventricular contractions.On or about twenty days post implantation, the filter was removed via an open chest procedure.The filter remains implanted; thus, unavailable for analysis.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.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.The events of premature ventricular contractions and pulmonary embolism may be related to the migration of the ivc filer.The physical presence of the device passing thru the cardiac chambers can contribute to arrhythmias.The pulmonary embolism can be a combination of the migrated filter and any previously trapped clots with in the filter.Pulmonary embolism can also contribute to cardiac arrhythmias.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: 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: 7052067
• MDR Text Key: 92720706
• Report Number: 1016427-2017-00767
• 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

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 466P306AU
• Device Lot Number: 15161784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2010
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 53 YR