MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FILTER SYSTEM; VENA CAVA FILTER

Catalog Number UNK DENALI

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

No hospital/medical records have been made available to the manufacturer.A journal article was received and reviewed.As the lot number for the device was not provided, a review of the device history records is not being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Journal article review: a retrospective study reviewed the data of inferior vena cava (ivc) filters placed during a 18 month period at 2 hospitals in 87 (47 men, 40 women) patients ranging 22-87 years of age.Twenty patients presented with pe, 45 with dvt, and 21 with both pe and dvt, 1 filter was placed prophylactically before surgery.Indications for filter placement included contraindication to anticoagulation (n=80), failure of anticoagulation (n=4) and complications of anticoagulation (n=3).Eighty four filters were deployed via jugular access and 3 filters were deployed via femoral access using standardized protocol.Eighty six filters were deployed in the infrarenal ivc and 1 filter was deployed in the suprarenal ivc due to free floating thrombus in the infrarenal cava.Follow-up imaging was performed in 71 patients.Radiograph and scout images were reviewed for filter tilt (>15 degrees), filter migration, crossing of the legs and filter detachment.Cross sectional imaging and venography were reviewed for filter tilt, penetration of legs (>3 mm outside the ivc), crossing of legs, filter detachment, and filter migration.Imaging showed penetration of 15 legs in five patients, caval occlusion in one patient, ivc filter thrombus in 3 patients, slight tilt (<15 degrees) in 5 patients, no leg detachments or crossed legs and no filter migrations.One filter was identified with slight tilt anteriorly and penetration of 2 limbs by a contrast-enhanced computed tomography (cect) scan of the abdomen.One filter was identified with slight tilt posteriorly on cect.One filter demonstrated penetration of 7 limbs on cect.One filter demonstrated penetration of 3 limbs on a noncontrast ct of the abdomen.Three patients were noted to have slight tilt laterally on abdominal and lumbar spine radiographs.Filter retrieval was carried out when patients no longer required mechanical protection against pe.Twenty one patients died before filter retrieval, with most causes of death not known.Twenty eight patients were lost to follow-up and 6 patients were not candidates for filter removal.Filter retrieval was attempted in 32 patients with successful retrieval in 31 patients.Two filters demonstrated penetration of 1 limb on venogram at the time of filter removal.Approximately six weeks post filter deployment, a filter retrieval procedure was started; but venogram demonstrated caval occlusion, precluding filter removal.The patient declined lysis or other intervention to treat the dvt.The study concluded that the denali filter was safe during deployment and readily retrievable.The overall safety following deployment was similar to those reported in literature and the incidence of filter detachments and migrations appeared to be less than the previous generation of bard devices.Reis, s.P., kovoor, j., sutphin, p.D., toomay, s., tripper, c., pillai, a.,.Kalva, s.P.(2016).Safety and effectiveness of the denali inferior vena cava filter: intermediate follow-up results.Vascular and endovascular surgery, 50(6), 385-390.Doi: 10.1177/1538574416666223.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

A journal article in vascular and endovascular surgery 2016 titled 'safety and effectiveness of the denali inferior vena cava filter: intermediate follow-up results' was reviewed.Approximately six weeks post filter deployment for a history of dvt and pe, the patient presented for retrieval of the filter.A venogram demonstrated caval occlusion and retrieval was not attempted.The patient declined treatment for the dvt.

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: based on the image provided, a filter was deployed, location unknown, can be confirmed.Based on the image provided, an occluded vena cava cannot be confirmed.Journal article review: a retrospective study reviewed the data of inferior vena cava (ivc) filters placed during a 18 month period at 2 hospitals in 87 (47 men, 40 women) patients ranging 22-87 years of age.Twenty patients presented with pe, 45 with dvt, and 21 with both pe and dvt, 1 filter was placed prophylactically before surgery.Indications for filter placement included contraindication to anticoagulation (n=80), failure of anticoagulation (n=4) and complications of anticoagulation (n=3).Eighty four filters were deployed via jugular access and 3 filters were deployed via femoral access using standardized protocol.Eighty six filters were deployed in the infrarenal ivc and 1 filter was deployed in the suprarenal ivc due to free floating thrombus in the infrarenal cava.Follow-up imaging was performed in 71 patients.Radiograph and scout images were reviewed for filter tilt (>15 degrees), filter migration, crossing of the legs and filter detachment.Cross sectional imaging and venography were reviewed for filter tilt, penetration of legs (>3 mm outside the ivc), crossing of legs, filter detachment, and filter migration.Imaging showed penetration of 15 legs in five patients, caval occlusion in one patient, ivc filter thrombus in 3 patients, slight tilt (<15 degrees) in 5 patients, no leg detachments or crossed legs and no filter migrations.One filter was identified with slight tilt anteriorly and penetration of 2 limbs by a contrast-enhanced computed tomography (cect) scan of the abdomen.One filter was identified with slight tilt posteriorly on cect.One filter demonstrated penetration of 7 limbs on cect.One filter demonstrated penetration of 3 limbs on a noncontrast ct of the abdomen.Three patients were noted to have slight tilt laterally on abdominal and lumbar spine radiographs.Filter retrieval was carried out when patients no longer required mechanical protection against pe.Twenty one patients died before filter retrieval, with most causes of death not known.Twenty eight patients were lost to follow-up and 6 patients were not candidates for filter removal.Filter retrieval was attempted in 32 patients with successful retrieval in 31 patients.Two filters demonstrated penetration of 1 limb on venogram at the time of filter removal.Approximately six weeks post filter deployment, a filter retrieval procedure was started; but venogram demonstrated caval occlusion, precluding filter removal.The patient declined lysis or other intervention to treat the dvt.The study concluded that the denali filter was safe during deployment and readily retrievable.The overall safety following deployment was similar to those reported in literature and the incidence of filter detachments and migrations appeared to be less than the previous generation of bard devices.Reis, s.P., kovoor, j., sutphin, p.D., toomay, s., trimmer, c., pillai, a.,.Kalva, s.P.(2016).Safety and effectiveness of the denali inferior vena cava filter: intermediate follow-up results.Vascular and endovascular surgery, 50(6), 385-390.Doi: 10.1177/1538574416666223.Conclusion: the device was not returned.Medical records were not provided.Images were provided.Based on the provided images, the investigation is inconclusive for any deficiency with the filter.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: -caval thrombosis/occlusion procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Additional mfr narrative: other relevant history; report source; date received by mfr.Initial reporter; evaluation codes (device), (conclusion).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

A journal article in vascular and endovascular surgery 2016 titled 'safety and effectiveness of the denali inferior vena cava filter: intermediate follow-up results' was reviewed.Approximately six weeks post filter deployment for a history of dvt and pe, the patient presented for retrieval of the filter.A contrast injected venogram demonstrated caval occlusion and retrieval was not attempted.The patient declined treatment for the dvt.

• Brand Name: DENALI FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6227307
• MDR Text Key: 64009826
• Report Number: 2020394-2016-01228
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK DENALI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 46 YR