MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN OPTEASE VENA CAVA FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466FXXXX

Device Problem Fracture (1260)

Patient Problem Anxiety (2328)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, fracture.Per the medical records provided, the patient was reported to be three weeks postpartum primary c-section; presented with right leg pain and was found to have extensive deep venous thrombosis (dvt), bilateral pulmonary embolism (pe) and a urinary tract infection (uti).The patient was started on lovenox but experienced shortness of breath, and it was felt that the patient could be likely experiencing recurrent pe; for that reason, the patient underwent placement of the inferior vena cava (ivc) filter and a mechanical thrombectomy with angiojet.About fourteen years and two months after the filter was implanted, the patient underwent a kidney, ureter and bladder (kub) x-ray.A clinical history of renal stones was noted at the time.The kub reported a fractured ivc filter and a displaced tubal ligation clip.According to the information received in the patient profile form (ppf), the patient reports fractured filter struts retained within the ivc, becoming aware of these events approximately fourteen years and two months after the filter implantation, and further experienced anxiety related to the filter.The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿filter-fractured - in patient and anxiety¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported events could not be conclusively determined.Procedural/handling factors, or vessel characteristics, although unknown, may have contributed to the reported events.According to the ifu, which is not intended as a mitigation of risk, filter fracture is a potential complication of vena cava filters.Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut.However, reports of adverse clinical sequelae from filter fractures are rare.Without images available for review, the reported events could not be confirmed or further clarified.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues.Since no lot number was provided a phr could not be generated.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.Should additional information become available, the file will be updated accordingly.

Event Description

As reported by the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to fracture.Per the medical records provided, the patient was reported to be three weeks postpartum primary c-section; presented with right leg pain and was found to have extensive deep venous thrombosis (dvt), bilateral pulmonary embolism (pe) and a urinary tract infection (uti).The patient was started on lovenox but experienced shortness of breath, and it was felt that the patient could be likely experiencing recurrent pe; for that reason, the patient underwent placement of the ivc filter and a mechanical thrombectomy with angiojet.About fourteen years and two months after the filter was implanted, the patient underwent a kidney, ureter and bladder (kub) x-ray.A clinical history of renal stones was noted at the time.The kub reported a fractured ivc filter and a displaced tubal ligation clip.According to the information received in the patient profile form (ppf), the patient reports fractured filter struts retained within the inferior vena cava (ivc), becoming aware of these events approximately fourteen years and two months after the filter implantation, and further experienced anxiety related to the filter.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 12259631
• MDR Text Key: 264711828
• Report Number: 1016427-2021-05205
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• 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
• Date Manufacturer Received: 07/12/2021
• 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
• Patient Age: 41 YR