MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466F220A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Perforation (2001); Perforation of Vessels (2135)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation.The indication for the filter implant, procedural details and medical history of the patient have not been provided and there is currently no additional information available for review.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could 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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without images available for review the reported events could not be confirmed or further clarified.Given the limited information available for review at this time, there is nothing to suggest that the reported events are 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 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 filter perforation.As a direct and proximate result, the patient suffered life-threatening injuries and damages and required extensive medical care and treatment.As a further proximate result, the patient has suffered and will suffer significant medical expenses, pain and suffering and other damages.

Manufacturer Narrative

It was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforation.The patient reported becoming aware of the event approximately twelve years and six months post implant.The patient also reported swelling of the legs, thighs and hands and anxiety related to the filter.According to the implant record the indication for the filter placement was bilateral pulmonary emboli (pe) and gastrointestinal (gi) bleed with contraindication to anticoagulation.The filter was placed via the right internal jugular vein and deployed in the infrarenal ivc.A triple lumen catheter was then successfully placed, via the same access site, into the superior vena cava.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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 pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.Without images available for review the reported events could not be confirmed or further clarified.Anxiety and swelling of the legs and hands do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review at this time, there is nothing to suggest that the reported events are 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

Per the implant records, the patient was reported to have a history of bilateral pulmonary emboli (pe) and gastrointestinal (gi) bleed with contraindication to anticoagulation.The patient¿s right neck was sterilely prepped and draped, and under ultrasound guidance, a needle was used to puncture the right internal jugular vein.A wire was then advanced into the inferior vena cava (ivc) followed by a measuring catheter.An inferior vena cavagram was performed demonstrating normal renal inflow at the l1-l2 level and no ivc thrombus.The optease filter was successfully deployed into the infrarenal ivc followed by successful placement of a triple lumen central venous catheter.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc, becoming aware of this event approximately twelve years and six months after the filter implantation.The patient further asserts to have suffered from swelling of the legs, thighs and hands and further experienced anxiety related to the filter.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• MDR Report Key: 12210570
• MDR Text Key: 262898016
• Report Number: 1016427-2021-05108
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 466F220A
• Device Lot Number: R0307019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK NEEDLE, UNK WIRE, UNK CATHETER
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR