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

Catalog Number DL900J

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Malposition of Device (2616); Activation Failure (3270)

Patient Problems Embolism (1829); No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2015

Event Type  Injury  

Manufacturer Narrative

No device and no medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Medical images were received and the investigation of the reported event is currently underway.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.Device remains implanted.

Event Description

It was reported that during the deployment of a jugular vena cava filter in a patient who was not tolerating anticoagulants, the filter legs did not fully expand.The filter then tilted and migrated to the upper vena cava proximal to the right atrium.Multiple attempts to retrieve the filter using a snare were unsuccessful and reportedly after forty-five minutes, the filter appeared to be stable, the health care provider then decided to leave the filter in place.It was said the patient was asymptomatic and there are no plans to retrieve the filter, reportedly because the patient has metastatic cancer.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.The lot met all release criteria.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 images provided, a denali jugular filter was deployed in an upright position within the ivc.The filter legs were crossed at the caudal anchors upon deployment.The filter became tilted caudally; with the filter apex inferior to the caudal anchors of the filter legs.Based on the images provided, the location of the filter cannot be confirmed.Conclusion: a manufacturing review was performed.The lot met all release criteria.The device was not returned.Five images were received.Based on the images provided, crossed limbs and filter tilt can be confirmed.As cine runs or ct images were not provided, the exact location of the filter can not be identified; therefore, filter migration can not be confirmed.The investigation for cephalad migration is inconclusive.The investigation for an unsuccessful retrieval attempt is inconclusive as cine runs were not provided.Failure to expand could lead to the filter tilting in the ivc.A tilted filter could potentially cause the filter to migrate.It is unknown if the physician twisted during advancement or deployment which could cause the filter legs to become crossed.The definitive root cause of the reported event is unknown.Labeling review: the current ifu (instructions for use) states: warnings/ potential complications: - delivery of the denali filter through the introducer sheath is advance only.Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.- movement, migration or tilt of the filter are known complications of vena cava filters.Migration of filters to the heart or lungs has been reported.There have also been reports of caudal migration of the filter.Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu.Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.-failure of filter expansion/incomplete expansion.- filter malposition - filter tilt.Note: it is possible that complications such as those described in the ¿warnings¿, ¿precautions¿, or ¿potential complications¿ sections of this instructions for use may affect the recoverability of the device and result in the clinician¿s decision to have the device remain permanently implanted.Precautions: - do not deliver the filter by pushing it beyond the end of the introducer sheath.To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath.Do not twist the pusher handle at anytime during this procedure.(b)(4).

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5048473
• MDR Text Key: 24769717
• Report Number: 2020394-2015-01563
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: DL900J
• Device Lot Number: GFZE3711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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: 72 YR
• Patient Weight: 60