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

Model Number 466FXXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 10/15/2019

Event Type  Death  

Event Description

As reported by the legal team, the patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused injury and damages to the patient, including, but not limited to perforation of ivc filter outside the vena cava.

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 perforation of inferior vena cava (ivc).The device was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿inferior vena cava perforation¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.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.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 ivc perforation 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 event is 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.

Manufacturer Narrative

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

Event Description

The medical records provided for review revealed a history of deep vein thrombosis (dvt), pulmonary embolus (pe), hypertension, chest pain/angina, coronary artery disease (2 stents), dyslipidemia, emphysema, peripheral vascular disease (8 stents), carotid stenosis, right femoral arteriovenous fistula treated with covered stent, distal abdominal aortic dissection with sac- treated with covered stents.Per the implant records, the patient was reported to have a history of dvt, pulmonary disease, hypertension in addition to recurrent chest pain status post percutaneous coronary intervention (pci) with an unprotected lesion in the proximal right and a questionable lesion on the ostial portion of the previously deployed ostial stent.The patient also had a complex history involving a distal abdominal aortic dissection with a sac, which was ballooned and stented with a covered stent and the sac was coiled; bilateral common iliac artery stents and a right common femoral artery arteriovenous fistula that was treated with a covered stent.The patient was cleared and recommended for inferior vena cava (ivc) interruption using an optease cordis filter.The patient underwent right coronary artery balloon angioplasty and stent using a drug diluting stent, in addition to balloon angioplasty of the mid right coronary artery stent which had been previously placed and showed moderate in-stent restenosis, and balloon angioplasty of the ostial right coronary artery stent which was placed in the past and showed mild-in stent restenosis.At the end of the percutaneous coronary intervention, intravascular ultrasound was performed showing that all the stents were widely patent with no residual intraluminal thrombus or dissection.A long cordis catheter was used along with a sheath, and the ivc optease filter was adequately placed without difficulty below the renal arteries.Placement appeared to be radial (not eccentric).At the end of the procedure the patient verbalized no complaints.Approximately eight years and eleven months after the filter was implanted, the patient underwent a computerized tomography (ct) scan indicated for filter evaluation.The scan reported an ivc cage filter in place with the upper tip in the posterior ivc at the level of the renal veins and the lower tip in the anterior ivc.The struts protrude slightly beyond the confines of the ivc.There is no surrounding fluid collection, mass effect or sign of hematoma.Other findings included severe atherosclerosis with stents in the iliac arteries, marked coronary artery calcifications and severe lumbar spondylosis.According to the patient profile form (ppf), perforation of filter struts was reported by the estate administrators approximately eight years and eleven months post implant.They also reported that the patient experienced anxiety related to the filter.The patient is deceased; however a cause of death nor a relationship to the device was provided.

Manufacturer Narrative

As reported a patient underwent placement of the optease vena cava filter.The filter subsequently malfunctioned and caused perforation of inferior vena cava (ivc) filter outside the vena cava.The patient is noted to be deceased, a cause of death or relationship to the device was not provided.The estate administrators reported becoming aware of the perforation approximately eight years and eleven months post implant.It was also reported that the patient experienced anxiety related to the filter.According to the medical record the patient had a history of deep veins thrombosis (dvt), pulmonary embolus (pe), hypertension, chest pain/angina, coronary artery disease (2 stents), dyslipidemia, emphysema, peripheral vascular disease (8 stents), carotid stenosis, right femoral arteriovenous fistula treated with covered stent 10/19/2010, distal abdominal aortic dissection with sac- treated with covered stents.Approximately five days prior to the filter implant a left heart catheterization, selective angiogram, arch aortogram, carotid arteriogram, subclavian, brachial, and axillary angiograms, abdominal aortogram and peripheral runoff study was performed.Findings noted moderate single vessel coronary artery, and peripheral vascular disease.The patient was scheduled for a staged procedure for intervention for instent restenosis of the right coronary artery.On the day of the filter implant the patient underwent right coronary artery balloon angioplasty and stenting and implant of an optease ivc filter.The filter was placed without difficulty well below the renal arteries and adequately placed.Other findings noted widely patent ivc and bilateral iliac veins.Approximately eight years and eleven months post implant, the patient underwent a computerized tomography (ct) scan to evaluate the filter.The results of the scan reported an ivc cage filter in place with the upper tip in the posterior ivc at the level of the renal veins and the lower tip in the anterior ivc.The struts protrude slightly beyond the confines of the ivc.There is no surrounding fluid collection, mass effect or sign of hematoma.Other findings included severe atherosclerosis with stents in the iliac arteries, marked coronary artery calcifications.The product remains implanted and unavailable 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 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 event could not be confirmed or further clarified.It was noted that the patient is deceased, however a cause of death or relation to the filter was not provided.Given the patient¿s extensive medical history there are multiple comorbidities that may have contributed to the event.Anxiety does not represent a device malfunction and may be related to underlying patient specific issues, history, and comorbidities.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
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12652602
• MDR Text Key: 281132861
• Report Number: 9616099-2021-04947
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009413
• UDI-Public: 20705032009413
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 466FXXXX
• Device Catalogue Number: 466F220A
• Device Lot Number: 15223026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2010
• 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
• Treatment: UNK SHEATH.; UNK.
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White