MAUDE Adverse Event Report: CORDIS CASHEL 466FXXXX; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2011

Event Type  malfunction  

Manufacturer Narrative

Kalva, s.P., marentis, t.C., yeddula, k., somarouthu, b., wicky, s., & stecker, m.S.(2010).Long-term safety and effectiveness of the ¿optease¿ vena cava filter. cardiovascular and interventional radiology, 34(2), 331-337.Doi:10.1007/s00270-010-9969-9 this article was found during a recent clinical evaluation review/literature search of this device.Please note that patient specific details (demographics, medical history and reason for intervention) are not available.  the devices are optease vena cava filters but the catalog and lot numbers are not available.  as noted in the publication by kalva et al long-term safety and effectiveness of the "optease" vena cava filter, cardiovasc intervent radiol (2011) 34(2): 331-337; in one patient, the filter was malpositioned (filter placed upside down), and subsequent attempts to retrieve the filter were unsuccessful.A non-cordis filter was then placed above the malpositioned optease filter in a suprarenal location.There were no other complications during placement.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.  the optease 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.Incorrect orientation of the filter is a known potential complication for all ivc filter implants and is listed in the instructions for use (ifu) as such.Per ifu, the optease must be implanted with the fixation barbs to the cranial end and retrieval hook to the caudal end of the filter.Patient, technique or procedural factors during the implantation and attempted retrieval may have contributed to the reported event.Given the limited information available for review at this time, there is nothing to suggest that the reported event is 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.

Event Description

As noted in the publication by kalva et al long-term safety and effectiveness of the "optease" vena cava filter, cardiovasc intervent radiol (2011) 34(2): 331-337; in one patient, the filter was malpositioned (filter placed upside down), and subsequent attempts to retrieve the filter were unsuccessful.A non-cordis filter was then placed above the malpositioned optease filter in a suprarenal location.There were no other complications during placement.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 6676737
• MDR Text Key: 78713432
• Report Number: 1016427-2017-00414
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/06/2017
• Date Manufacturer Received: 06/06/2017
• 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
• Treatment: COOK TULIP FILTER