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

Model Number 466F220A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Perforation (2001); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

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 perforated the vena cava and a fractured strut is embedded in the vena cava wall.

Event Description

Per the implant records, the patient was reported to have a history of uterine and vaginal bleeding, endometriosis and methamphetamine abuse and was on oral contraceptives for menometrorrhagia control.The patient presented to the hospital a day prior to the index procedure with shortness of breath, cough weakness and agitation and was found to have multiple pulmonary emboli (pe) with bilateral pulmonary infiltrations.Pre-procedure medications included provera, birth control pills, and xanax.Placement of the inferior vena cava (ivc) filter was advised for acute pulmonary embolus secondary to estrogen and concurrent tobacco use.The right neck was prepped and draped in the usual sterile fashion and the right internal jugular vein was cannulated using ultrasound guidance.The inferior vena cava was selectively catheterized by fluoroscopy.An inferior venacavogram was completed, which measured the size of the inferior vena cava at less than 30mm and identified the renal vein.The filter was successfully deployed infrarenal.Following filter placement, the patient underwent a total abdominal hysterectomy.The patient tolerated the procedure well.About eleven years and three months after the filter was implanted, the patient underwent an abdominal computerized tomography (ct) scan indicated for filter evaluation.Results of the scan noted the head of the filter at the renal vein confluence and that lateral struts appear to protrude beyond the wall of the ivc 3.5mm to 5mm.Incidental findings noted: hepatomegaly, right renal kidney stone, and moderate aortic calcification.According to the information received in the patient profile form (ppf), the patient reports perforation of filter struts outside the ivc and fractured filter strut retained and embedded in the vena cava wall.Becoming aware of these events approximately eleven years and three months after the filter implantation, and further experienced anxiety related to the filter.Approximately twelve years and four months after the filter implantation, the patient had a telephonic follow up for leg swelling in relation to the filter.The information reviewed by the physician with the patient at the time noted that the patient started to experience leg swelling on or around eleven years and six months post implant.A ct venogram performed a month prior to the follow up consult demonstrated an optease filter with the inferior hook embedded in the ivc wall, and penetration of all major struts through the ivc.The filter does appear to be intact without fracture or embolization as it had been previously reported.The ivc and iliac veins are widely patent.The report of the exam was not provided.The consulting physician indicated that the ivc filter was not the source of the patient¿s leg swelling and felt that attempting a complex retrieval procedure outweighed the risks of leaving the filter implanted.It should also be noted that the patient had a negative coagulation workup.

Manufacturer Narrative

As reported a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused filter perforated the vena cava and a fractured strut is embedded in the vena cava wall.The patient reported becoming aware of the events approximately eleven years and three months post implant.The patient also reported anxiety related to the filter.According to the implant record the patient had a history of uterine and vaginal bleeding, endometriosis and methamphetamine abuse and was on oral contraceptives for menometrorrhagia control.The patient presented to the hospital a day prior to the index procedure with shortness of breath, cough weakness and agitation and was found to have multiple pulmonary emboli (pe) with bilateral pulmonary infiltrations.Pre-procedure medications included provera, birth control pills, and xanax.Placement of the inferior vena cava (ivc) filter was advised for acute pulmonary embolus secondary to estrogen and concurrent tobacco use.The filter was placed via the right internal jugular veins and deployed infrarenally.Following filter placement, the patient underwent a total abdominal hysterectomy.The patient tolerated the procedure well.Approximately eleven years and three months post implant an abdominal computerized tomography (ct) scan was performed to evaluate the filter.Results of the scan noted the head of the filter at the renal vein confluence and that lateral struts appear to protrude beyond the wall of the ivc 3.5mm to 5mm.Approximately twelve years and four months post implant, the patient had a follow up for leg swelling in relation to the filter.The information reviewed by the physician with the patient at the time, noted that the patient started to experience leg swelling on or around eleven years and six months post implant.A ct venogram performed a month prior to the follow up demonstrated an optease filter with the inferior hook embedded in the ivc wall, and penetration of all major struts through the ivc.The filter does appear to be intact without fracture or embolization as it had been previously reported.The ivc and iliac veins are widely patent.The consulting physician indicated that the ivc filter was not the source of the patient¿s leg swelling and felt that attempting a complex retrieval procedure outweighed the risks of leaving the filter implanted.It should also be noted that the patient had a negative coagulation workup.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.The optease vena cava filter is indicated in the us for retrieval up to 14 days post implantation.Following this period of time, and as early as 12 days, there is potential for endothelialization (growth of endothelial cells within the inner wall of the vessel) around the filter struts.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 ifu also states that filter fracture with perforation 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.The timing and mechanism of the events 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.Anxiety does 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.

• 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: 12224831
• MDR Text Key: 263454885
• Report Number: 1016427-2021-05119
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R1107244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK 5F MICROPUNCTURE KIT, UNK SHEATH.; UNKNOWN.
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 70