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

Model Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/09/2020

Event Type  Death  

Manufacturer Narrative

This complaint was found during a recent clinical evaluation review/literature search of this device.The citation is as follows: gregorio, m.A., guirola, j.A., urbano, j., díaz-lorenzo, i., muñoz, j.J., villacastin, e., jimenez, d.(2020).Spanish multicenter real ¿ life registry of retrievable vena cava filters (refivec).Cvir endovascular, 3(1).Doi:10.1186/s42155-020-00114-5.Specific product details are not available.The exact event date is unknown.Complaint conclusion: as reported in the literature article by gregorio, m.A.D., guirola, j.A., urbano, j., díaz-lorenzo, i., muñoz, j.J., villacastin, e., jimenez, d.(2020).Spanish multicenter real ¿ life registry of retrievable vena cava filters (refivec).Cvir endovascular, 3(1).Doi: 10.1186/s42155-020-00114-5, 6 optease inferior vena cava filters could not be removed because the patient died during their hospital stay.The devices will not be returned for evaluation.The products were not returned for analysis.No lot numbers were provided therefore product history record (phr) reviews could not be generated.The reported ¿death¿ could not be confirmed as the devices were not returned for analysis.As the causes of death were not provided the complaint devices cannot be conclusively dissociated from the events.The exact causes could not be determined.Vessel characteristics are unknown.As no lot number, catalogue code or other product information was supplied phrs could not be completed.According to the safety information in the instructions for use ¿the optease® retrievable filter can be retrieved up to and including 12 days after placement.The optease® retrievable filter is considered a permanent implant if it is not retrieved within the specified time period.¿ the limited information available does not suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the literature article by gregorio, m.A.D., guirola, j.A., urbano, j., díaz-lorenzo, i., muñoz, j.J., villacastin, e., ¿ jimenez, d.(2020).Spanish multicenter real ¿ life registry of retrievable vena cava filters (refivec).Cvir endovascular, 3(1).Doi: 10.1186/s42155-020-00114-5, 6 optease inferior vena cava filters could not be removed because the patient died during their hospital stay.The devices will not be returned for evaluation.

• Brand Name: 466FXXXX
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 10248189
• MDR Text Key: 198076069
• Report Number: 1016427-2020-04163
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Death