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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR

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CORDIS CORPORATION FEMORAL 55CM KIT FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number 466F230AF
Device Problems Fracture (1260); Failure to Align (2522); Migration (4003)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Atrial Fibrillation (1729); Thrombosis (2100); Heart Failure (2206); No Code Available (3191)
Event Date 06/15/2017
Event Type  Injury  
Manufacturer Narrative

Reporter occupation: other, senior counsel, litigation. (b)(4). As reported, the patient underwent placement of an optease retrievable vena cava filter. The patient had initially been hospitalized after head trauma with a cerebral hemorrhage. Approximately two weeks after admission, the patient underwent filter implantation placed in the superior vena cava (svc). The filter was placed such that the retrieval hook was pointing toward the patient's feet and the fixation barbs were pointing toward his head. As such the fixation barbs were not correctly oriented to resist pressure from blood flow and/or blood clots when placed in the svc. Information regarding the access site used was not provided. Less than a week after the filter implantation, a computerized tomography (ct) scan revealed that the device had migrated to the patient¿s right ventricle. The patient was discharged from hospital twelve days after the index procedure. Three days later, the patient was re-admitted. Radiological testing re-confirmed the location of the filter in the patient¿s heart. The patient was discharged twelve days after having been admitted with the filter location unchanged. At some point after the filter implantation, the patient experienced damage to the tricuspid valve, right heart failure, severe tricuspid valve regurgitation, paroxysmal atrial fibrillation, dizziness, weakness and several falls. These symptoms were reported to have been the result of the filter migration. Approximately five and a half months after the index procedure, diagnostic testing revealed evidence suggestive of filter migration into the patient¿s right ventricle. Approximately one week later, the patient underwent open heart to remove the fractured and migrated filter and to remove and replace the patient¿s tricuspid valve. During the procedure, it was noted that the filter hooks had torn through the tricuspid valve. Clot was noted on the device and the filter was broken in two places with the hook lodged in the papillary muscle of the anterior leaflet. The septal and anterior leaflets of the valve were destroyed. The anterior leaflet had a torn cord to the anterolateral papillary muscle, but the postero-medial muscle was intact. The patient was treated with the placement of a porcine valve. The patient was discharged from hospital four days after the surgery to a rehabilitation facility. The patient further reported having experienced severe pain during the post-operative recovery, mental anguish, psychological pain associated with the filter. 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 retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) 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. Without images or procedural films for review, the reported filter malposition, migration, fracture and device embedment events could not be confirmed and the exact cause could not be determined. From the reported catalog number, it appears that an optease retrievable vena cava filter used was indicated for a femoral approach according to the instructions for use (ifu). Information regarding the access site used was not provided. Ivc filter migration is a known potential adverse event associated with all ivc filter implants and is listed in the ifu as such. Possible causes for filter migration include mega cava, wire entrapment during central venous catheter placement, ¿sail¿ effect (cranial migration) of large clot burden within the filter, mechanical device failure, and operator error. Physiologic causes of migration may result from temporary dysmorphism of the ivc including bending, coughing or valsalva maneuvers resulting in dislodgment of the filter. Some studies suggest that strenuous physical activity and increased intra-abdominal pressure can lead to migration of ivc filters. The ifu states that filter fracture 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 predominant concern for embedding within the wall of the ivc is the development of endothelialization. Endothelialization is the healing of the inner surfaces of vessels or grafts by endothelial cells. This is the normal process whereby the body heals and recovers from invasive procedures. The optease retrievable vena cava filter is indicated for retrieval up to 23 days post-implantation. Following this period of time, and as early as twelve days, there is potential for endothelialization around the filter struts. Usage of the product other than that indicated in the product's ifu may involve additional risks not described in the labeling. Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction. Due to the nature of the complaint, the reported pain, heart injury, right heart failure and paroxysmal atrial fibrillation experienced by the patient could not be confirmed and the exact cause could not be determined. These clinical events do not represent evidence of a device malfunction. Clinical factors that may have influenced these events include the patient¿s pre-existing co-morbidities, pharmacological issues and lesion characteristics. In addition, it is possible that these issues were related to procedural factors. Given the limited information available for review, there is nothing to suggest that a malfunction in 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. Please note that this is the initial/final report for this product.

 
Event Description

As reported by the legal brief, the patient underwent placement of a optease vena cava filter. The patient was hospitalized for head trauma an hemorrhage. Approximately two weeks later an optease vena cava filter was placed into the patient's superior vena cava. The filter was placed in a different orientation than how the filter would normally be placed. It was placed such that the retrieval hook was pointing toward the patient's feet and the fixation barbs were pointing toward his head. As such the fixation barbs were not correctly oriented to resist pressure from blood flow and/or blood clots when placed in the superior vena cava. No later than one week after the index procedure, a computed tomography (ct) scan revealed that the device had migrated to the patient's right ventricle and could be seen in the patient's heart. The patient was discharged twelve days after the index procedure. Three days after being discharged, the patient was hospitalized again. He underwent radiological imaging procedures, which repeatedly demonstrated that the filter had migrated to the patient's heart. The patient was discharged twelve days after admission with the filter still lodged in his heart. The patient experienced complications secondary to the filter migration. The symptoms included damage to the right tricuspid valve, right heart failure, severe tricuspid valve regurgitation, paroxysmal atrial fibrillation, dizziness, weakness and several falls. Approximately five months and two weeks after the index procedure an imaging study was highly suggestive of migration of the filter into the patient's right ventricle. Approximately five months and three weeks after the index procedure the patient had open heart surgery to remove the fractured migrated filter and to remove/replace the patient's tricuspid valve with a pig valve and epicardial lead. During the procedure it as found that the hooks had torn though the tricuspid valve and these were stented opened. There was still clot on the device, the filter was broken in 2 places and the hook was lodged in the papillary muscle of the anterior leaflet. The septal leaflet was completely destroyed. The anterior leaflet had a torn cord to the anterolateral papillary muscle, but the posterior medial was intact. The posterior leaflet was completely torn. A 29 mm medtronic porcine valve was implanted. The patient survived the procedure in critical but stable condition and was ultimately discharged to a rehabilitation facility four days after the procedure. He suffered severe pain during his recovery. He also suffered permanent injury to his heart and will likely require a future valve replacement. The patient experienced and will continue to experience mental anguish, economic loss, numerous physical and emotional damages, as well as psychological pain, severe physical pain and suffering, and loss of enjoyment of life.

 
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Brand NameFEMORAL 55CM KIT
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key10233254
MDR Text Key197593705
Report Number9616099-2020-03771
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK034050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device MODEL Number466F230AF
Device Catalogue Number466F230AF
Device LOT Number17594358
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/06/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2020 Patient Sequence Number: 1
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