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

Catalog Number DL900F

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images 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.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during a vena cava filter deployment procedure, during deployment the last two filter legs remained inside the deployment sheath.A.035 guidewire was used to complete the deployment of the filter; however, the filter and guidewire became tangled together.Access was gained in the jugular vein as a snare device was used to capture and retrieve the vena cava filter without incident.Another filter was prepped and deployed successfully.There was no reported patient injury.

Manufacturer Narrative

A further clinical review of the event details on (b)(6) 2015 has been completed and identified a change in the mdr reportability.This event is reportable as a malfunction mdr, while a partial deployment of an inferior vena cava filter required procedural improvisation by the medical professional, there was no patient injury or adverse patient outcome.: mdr classification; type of reportable event.Outcomes attributed to adverse event.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.

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 inspection: the filter is partially retraced within a recovery cone removal system.This is against the instructions for use (ifu), as the denali filter should only be retrieved using a dual sheath snare device.The shaft handle of the recovery cone was bent and the proximal portion of the sheath (near the strain relief) appeared to be slightly bunched or crinkled.There was no alleged deficiency with the recovery cone and the damage may have occurred after the procedure or during packaging for return.The distal tip of the recovery cone sheath was flared.Functional/performance evaluation: the denali filter was removed from the recovery cone.All 6 arms and 6 legs were present and intact.Two legs and one arm were crossed.No crossed limbs were reported by the user.It is possible the limbs became crossed during retraction into the sheath.The polyurethane cone was separated from one of the prongs.Dimensional evaluation: the limbs were uncrossed.Heat was applied and the filter took the appropriate shape.All measurements met the required specifications.Medical records/image/photo review: no medical records or medical images have been made available to the manufacturer.Conclusion: the denali filter was returned partially retracted within a recovery cone removal system.As neither images or cine runs were provided, the investigation is inconclusive for partial deployment.Based upon the available information, the definitive root cause for this event is unknown.It is unknown if procedural factors contributed to this event.It should be noted that per the instructions for use (ifu), the denali filter should be retrieved using an intravascular snare only.The filter was removed using a recovery cone which is only intended for use with the g2 x filter, g2 express filter, g2 filter and recovery filter.Labeling review: the denali femoral system instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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: 5271745
• MDR Text Key: 32858466
• Report Number: 2020394-2015-01974
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)180831(10)GFZG3076
• 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,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: DL900F
• Device Lot Number: GFZG3076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/11/2016; 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 82