MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466F220B

Device Problems Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, a call was received that a physician had implanted a previous generation optease inferior vena cava (ivc) filter in the upside down position.The access was from the patient's femoral vein using a jugular kit thus putting in the filter incorrectly.The physician wanted to remove the filter and had attempted to multiple times unsuccessfully.It was reported that it was almost as the hook was facing the wall of the vena cava and the physician was unable to get the snare he was using around the hook.There was no reported harm to the patient and the physician is planning to re-attempt removal of the filter sometime next week.Additional information has been requested.

Manufacturer Narrative

Additional information received indicated that this is the only case being reported.The product lot number was not provided.The product packaging material and product delivery system are not available for inspection.The indication for filter insertion was pulmonary embolism (pe).There was no thrombus present at the delivery site.Anticoagulation therapy was lovenox.There was no contraindication for anticoagulation or recurrent pe in spite of anticoagulation.Pre and post imaging was completed.The size and shape of the vena cava was within normal limits with the size estimated during angiography.There was no deployment difficulty reported.Vessel characteristics were normal.There were no acute bends or tortuosity noted.There was no reported difficulty or resistance/friction while advancing the deployment sheath to the deployment target.There was no reported difficulty or resistance/friction while advancing the filter to the deployment target.The obturator remained fixed while the deployment sheath was pulled back over the obturator.It was verified under fluoroscopy that the filter was not in a side vessel.Procedural films are available.No additional information is available.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, a call was received that a physician had implanted a ¿previous generation¿ optease inferior vena cava (ivc) filter in the upside down position.The access was from the patient¿s femoral vein using a jugular kit thus putting in the filter incorrectly.The user thought ¿the arrows meant the filter had to be placed with the arrow pointing in the direction of the site they wanted to retrieve from.¿ the physician wanted to remove the filter and had attempted to multiple times unsuccessfully.It was reported that it was almost as the hook was facing the wall of the vena cava and the physician was unable to get the snare he was using around the hook.The product lot number was not provided.The product packaging material and product delivery system are not available for inspection.The indication for filter insertion was pulmonary embolism (pe).There was no thrombus present at the delivery site.Anticoagulation therapy was lovenox.There was no contraindication for anticoagulation or recurrent pe in spite of anticoagulation.Pre and post imaging was completed.The size and shape of the vena cava was within normal limits with the size estimated during angiography.There was no deployment difficulty reported.Vessel characteristics were normal.There were no acute bends or tortuosity noted.There was no reported difficulty or resistance/friction while advancing the deployment sheath to the deployment target.There was no reported difficulty or resistance/friction while advancing the filter to the deployment target.The obturator remained fixed while the deployment sheath was pulled back over the obturator.It was verified under fluoroscopy that the filter was not in a side vessel.Procedural films have not been provided for review.Follow up with the account noted no additional information is available.There was no reported harm to the patient and the physician is planning to re-attempt removal of the filter sometime next week.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.Without procedural films for review, the reported inaccurate placement, tilt and retrieval difficulty could not be confirmed and the exact cause of the difficulty experienced by the customer could not be conclusively determined.The reported event notes, ¿access was from the patient¿s femoral vein using a jugular kit thus putting in the filter incorrectly¿ and the user thought ¿the arrows meant the filter had to be placed with the arrow pointing in the direction of the site they wanted to retrieve from.¿ as such, it appears that user/handling factors likely contributed to the upside-down placement of the filter.The instructions for use instructs, ¿according to the selected venous access site, determine which end of the storage tube (containing the filter) is to be placed into the valve of the sheath introducer.This is indicated by the printed colored arrows and text (femoral: green; jugular/antecubital: blue) on the storage tube.The arrow of the desired access site will point into the sheath introducer hemostasis valve.Place the appropriate end of the storage tube (containing the optease® filter), as far as possible into the sheath introducer hemostasis valve.¿ follow up was conducted with the user to ensure successful use of the device in the future.There is no indication of a design or manufacturing related cause for this event; therefore, no corrective action will be taken at this time.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5667191
• MDR Text Key: 45534660
• Report Number: 9616099-2016-00254
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F220B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention