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

Model Number DL900F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

No medical records were provided to the manufacturer.X-ray is pending.The lot number for the device was provided.The device history records is currently under review.The investigation is currently under way.( expiration date: 06/2021).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 during a vena cava (ivc) filter deployment procedure, the filter legs allegedly failed to expand.It was further reported that the filter allegedly migrated toward right ventricular.Reportedly, the health care provider was not able to retrieve the filter which result in transferring the patient to the hospital for possible intervention.Patient status is unknown.

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 complaint reported to date for this lot number and failure mode.Investigation summary:the device was not returned for evaluation.Medical records were not provided for review.Images were provided and reviewed.Based on the images provided, the investigation is confirmed for failure to expand and filter migration.However, the investigation is inconclusive for retrieval difficulties.Per the provided images, the filter arms and legs did not fully expand in the right iliac vein.Per the provided event details, attempted retrieval of the filter with the deployment sheath resulted in the filter becoming loose and migrating.Per the ifu, the denali filter is designed for deployment in the inferior vena cava.Therefore, deployment in the right iliac vein could have contributed to the failed limb expansion and subsequent migration of the filter.However, the definitive root cause is unknown.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.The current ifu (instructions for use) states: contraindications for use: contraindications for use the denali vena cava filter should not be implanted in: patients with an ivc diameter larger than 28mm warnings: do not deploy the filter prior to proper positioning in the ivc, as the denali vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Precautions: position the filter snare hook 1cm below the lowest renal vein.

Event Description

It was reported that during a vena cava (ivc) filter deployment procedure, the filter legs allegedly failed to expand.It was further reported that the filter allegedly migrated toward right ventricular.Reportedly, the health care provider was not able to retrieve the filter which result in transferring the patient to the hospital for possible intervention.Patient status is unknown.

• Brand Name: DENALI VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7906123
• MDR Text Key: 121605040
• Report Number: 2020394-2018-01786
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFCS2585
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR