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

Catalog Number DL900F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 07/07/2014

Event Type  Injury  

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: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. The investigation is inconclusive for filter tilt and removal difficulties. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: snf: the current ifu (instructions for use) states: note: the dome of the filter will normally descend 1-2cm during shape recovery so that its tip will be lower than its actual position in the introducer before unsheathing. If the vena cava is too small to accommodate the fully centered filter dome, the dome may tilt toward the vena cava wall, or assume a spindle or cone configuration. These variations are functionally effective in undersized lumens. Rnf: the current ifu (instructions for use) states: warnings/potential complications: possible complications include but are not limited to the following: movement or migration of the filter is a known complication. This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu. G2/g2 express/g2x/eclipse/meridian/denali: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters; filter tilt; filter malposition. 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. 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 that approximately four months post vena cava filter deployment, an attempt to retrieve the tilted filter was unsuccessful. Approximately 15 months post filter deployment, a second attempt to retrieve the filter was also unsuccessful. No other reported attempts are made to retrieve the filter. No other pertinent patient or medical information was provided leading up to or surrounding this event. The patient status was not provided.

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: as medical images were not provided, a review could not be performed. Conclusion: the device was not returned. Images and medical records were not provided. The investigation is inconclusive for filter tilt and removal difficulties. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters. Filter tilt. Filter malposition. 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. 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 that approximately four months post vena cava filter deployment, an attempt to retrieve the tilted filter was unsuccessful. Approximately 15 months post filter deployment, a second attempt to retrieve the filter was also unsuccessful. No other reported attempts are made to retrieve the filter. No other pertinent patient or medical information was provided leading up to or surrounding this event. The patient status was not provided.

• Brand Name: DENALI FEMORAL 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: 5690366
• MDR Text Key: 46253923
• Report Number: 2020394-2016-00504
• 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: consumer,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: DL900F
• Device Lot Number: GFXK3041
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2018
• 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 Treatment Data

Date Received: 05/31/2016 Patient Sequence Number: 1