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

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Pseudoaneurysm (2605)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: rigid forceps (lymol medical, (b)(4)) or excimer laser (glidelighttm laser sheath; philips medical, (b)(4)).16 or 18 fr sheath (flexorvr ; cook medical, (b)(4)).26 fr sheath (dryseal, gore, (b)(4)).As reported in the literature article hadied, m.O., hieromnimon, m., kapke, j., nijahawan, k., ha, t.V., navuluri, r., & ahmed, o.(2020).Caval pseudoaneurysms following complex inferior vena cava filter removal: clinical significance and patient outcomes.Vascular, 170853812096121.Doi:10.1177/1708538120961217 , a patient developed a pseudoaneurysm after retrieval of an optease venacaval filter.The filter was also found to have a partial fracture on removal, and it was noted to have caused perforation.The pseudoaneurysm was treated with balloon angioplasty with a non-cordis balloon.The filter was removed using an unknown wire loop and excimer laser.Retrieval was performed with coaxial placement of a 16 fr non cordis laser sheath and outer dissector device included with the laser.Access was obtained via the common femoral vein (cfv) with an unknown 26f sheath.The physician had at least 5 years¿ experience in ivc filter removal.The patient received weight-based anticoagulation with intravenous unfractionated heparin periprocedure.The product was not returned for analysis.No lot number was provided therefore product history record (phr) review could not be generated.The reported ¿filter fractured - in patient¿, ¿perforation¿ and ¿pseudoaneurysm¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.It is also not known how long the filters were implanted.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.Retrieval of the optease retrievable filter is possible only from femoral vein approach.Retrieval is performed using the cordis optease retrieval catheter and the recommended accessories.These devices used for filter retrieval are not included in the optease retrievable filter introduction set.The ifu for optease retrievable filter retrieval is contained in the cordis optease retrieval catheter packaging.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.Retrieval of the optease retrievable filter with a filter fracture present may result in complications.¿ the optease retrievable filter should be removed using a snare and suitable guiding catheter.Removal by wire loop and excimer laser and after a potentially extended period is a violation of the ifu and therefore considered off label usage.The repair of a pseudoaneurysm and perforation, which may have been caused by the removal method, by balloon angioplasty fulfills the standard of care required.The limited information available does not suggest a design or manufacturing related cause for the reported events; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported in the literature article hadied, m.O., hieromnimon, m., kapke, j., nijahawan, k., ha, t.V., navuluri, r., & ahmed, o.(2020).Caval pseudoaneurysms following complex inferior vena cava filter removal: clinical significance and patient outcomes.Vascular, 170853812096121.Doi:10.1177/1708538120961217, a patient developed a pseudoaneurysm after retrieval of an optease venacaval filter.The filter was also found to have a partial fracture on removal, and it was noted to have caused perforation.The pseudoaneurysm was treated with balloon angioplasty with a non-cordis balloon.The filter was removed using an unknown wire loop and excimer laser.Retrieval was performed with coaxial placement of a 16 fr non cordis laser sheath and outer dissector device included with the laser.Access was obtained via the common femoral vein (cfv) with an unknown 26f sheath.The physician had at least 5 years¿ experience in ivc filter removal.The patient received weight-based anticoagulation with intravenous unfractionated heparin periprocedure.

• Brand Name: UNKNOWN OPTEASE VENA CAVA FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; 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: 10734421
• MDR Text Key: 213486197
• Report Number: 1016427-2020-04488
• 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: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 466FXXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• 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): Hospitalization; Life Threatening; Required Intervention