MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolus (1830); Occlusion (1984); No Code Available (3191)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, the patient underwent placement of a trapease vena cava filter.The patient had severe and constant chest pains and pulmonary embolisms.Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism, contraindication to anticoagulation, morbid obesity, pinched nerve in back and continual pain management for back.The patient also has a history of asthma and impaired respiratory status described as a productive cough with green mucus, but with no shortness of breath.The filter was placed below the renal veins.The patient tolerated the index procedure well.According to the patient profile form (ppf), the patient experienced blood clots, occlusion of the inferior vena cava, respiratory problems, pain, discomfort, mental anguish and the filter is unable to be removed.

Manufacturer Narrative

As reported, the patient underwent placement of a trapease inferior vena cava (ivc) filter.The indication for filter placement was chest pains and pulmonary embolisms.Additional information received per the medical records indicate that the patient has a history of bilateral pulmonary embolism, contraindication to anticoagulation, morbid obesity, pinched nerve in back and continual pain management for back.The patient also has a history of asthma and impaired respiratory status described as a productive cough with green mucus, but with no shortness of breath.The filter was placed below the renal veins.The patient tolerated the index procedure well.Per the patient profile form (ppf), the patient experienced blood clots, occlusion of the inferior vena cava, respiratory problems, pain, discomfort, mental anguish and the filter is unable to be removed.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.Blood clots, pulmonary embolism and occlusive thrombosis within the filter and vasculature do not represent a device malfunction.Chest pain, respiratory difficulty, pain and anxiety do not represent a device malfunction and may be related to underlying patient related issues.Clinical factors that may have influenced the event include patient, pharmacological and lesion characteristics.Without procedural films or images for review the reported event(s) could not be confirmed.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: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7442150
• MDR Text Key: 105874823
• Report Number: 9616099-2018-02062
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Catalogue Number: 466F220A
• Device Lot Number: 15216775
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER; UNKNOWN GUIDE WIRE
• Patient Outcome(s): Other
• Patient Age: 47 YR