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

Model Number N/A

Device Problem Failure to Align (2522)

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

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Please note that device reported is an optease vena cava filter and for which the catalog and lot numbers are not currently available.Patient age and medical history were also not provided.If obtained, a follow up report will be submitted within 30 days upon receipt.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 and tilt.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.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 in the legal brief, a patient was treated with an optease vena cava filter which subsequently malfunctioned and caused injury and damage, including, but not limited to filter perforation and tilt.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

After further review of additional information received, the following sections have been updated accordingly: a2, b2, b3, b4, b5, b6, b7, d1, d4, g2, g3, g6, h1, h2, h4 and h6.Additional information is pending and will be submitted within 30 days of receipt.

Event Description

Medical records included radiology reports for x-rays of a fractured left femur, left tibia, fibula, symphysis pubis and right sacroiliac joint.The x-rays were post reduction and repair of the fractures.These repairs were performed prior to the filter implant.  a computed tomography (ct) scan performed prior to filter implantation showed a stable resolving perisplenic hematoma, unchanging splenic laceration and progressing splenomegaly.A completely resolved fluid collection in the morrison¿s pouch and decreasing pelvic fluid collection and newly developed pulmonary consolidation of both lower lobes, with pulmonary consolidation of the right lobe with bilateral pleural effusions more on the right was seen.There was also unchanging mild hepatomegaly and an opacified gallbladder.A ct of the brain was normal   according to the medical record, the indication for the filter placement was trauma.A 6f right femoral vein catheterization was done, followed by an inferior vena cava gram.There was no evidence of thrombosis or extrinsic abnormalities seen.The filter was placed, and the patient tolerated the procedure well. additional information received per the patient profile form (ppf) states that the patient experienced filter tilt and perforation of filter struts outside the inferior vena cava (ivc).The patient became aware of the reported events approximately seven years and ten months after the index procedure.The patient also experienced pain (side, back, abdominal), swelling in both legs, anxiety and depression.

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 and tilt.The patient reported becoming aware of the events approximately seven years and ten months post implant.The patient also reported pain (side, back, abdominal), swelling in both legs, anxiety and depression.According to the medical records the indication for the filter implant was trauma.The patient was noted to have a fractured left femur, left tibia, fibula, symphysis pubis and right sacroiliac joint.A computed tomography (ct) scan performed prior to filter implant showed a stable resolving peri-splenic hematoma, unchanging splenic laceration and progressing splenomegaly.A completely resolved fluid collection in the morrison¿s pouch and decreasing pelvic fluid collection and newly developed pulmonary consolidation of both lower lobes, with pulmonary consolidation of the right lobe with bilateral pleural effusions noted more on the right.There was also unchanging mild hepatomegaly and an opacified gallbladder.A ct of the brain was normal.The filter was placed via the right femoral vein and deployed after vena cava gram found no evidence of thrombosis or extrinsic abnormalities.The patient tolerated the procedure well.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.Ivc filter tilt has been associated with operator technique and vessel anatomy, specifically asymmetry and tortuosity.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.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined as to the cause of the events.Without images available for review the reported events could not be confirmed or further clarified.Pain, leg swelling, anxiety and depression do not represent a device malfunction and may be related to underlying patient specific issues, including but not limited to previous trauma.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.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 12166575
• MDR Text Key: 261511155
• Report Number: 1016427-2021-05078
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 466F220A
• Device Lot Number: 15694650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR