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

Catalog Number DL900F

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

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.Images were provided and review is currently underway.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.

Event Description

It was reported during a femoral vena cava filter deployment procedure, the pusher pad allegedly became entangled.When the filter disengaged it deployed down near the iliac bifurcation and was severely tilted.Jugular access was then gained to retrieve the filter; however, was unsuccessful as the filter hook could not be captured.The filter remains implanted with retrieval planned once the filter is no longer necessary.There was no impact or consequence to the patient reported.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.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, location of filter deployment and filter tilt cannot be confirmed.Based on the image provided, three filter limbs are not straight as intended, and appear to be bending and the filter can be confirmed for a denali filter.Conclusion: the device was not returned.One image was provided.There are no images or cine runs showing the deployment of the filter; therefore the investigation for difficult to deploy is inconclusive.As the image provided is a dsa image and no boney land markings are identified the location of the filter cannot be confirmed; therefore, the investigation for positioning issue is inconclusive.The entire vena cava cannot be visualized as the contrast does not extend superior to the filter placement, thus filter tilt cannot be confirmed.As there are no images showing an attempt to retrieve the filter, the investigation is inconclusive for an unsuccessful retrieval attempt.Three limbs are not correctly oriented and appear to be bent; therefore, the investigation is confirmed for material deformation.Based upon the available information, the definitive root cause for this event is unknown.It is unknown if patient and/or procedural factors contributed to this event.Labeling review: the current ifu (instructions for use) states: warnings: 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.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: if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.It is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement.Care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided.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.Potential complications: movement, migration or tilt are known complications of vena cava filters.Filter malposition, filter tilt.(b)(4).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.

• Brand Name: DENALI FEMORAL 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: 5419668
• MDR Text Key: 38332549
• Report Number: 2020394-2016-00167
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)180731(10)GFZF3786
• 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: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: DL900F
• Device Lot Number: GFZF3786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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 Age: 57 YR