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

Catalog Number DL900F

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/20/2015

Event Type  malfunction  

Event Description

It was reported that during a vena cava retrieval procedure, the filter was retrieved with 2 legs crossed with "fibrine" on it.There was no reported pt injury.

Manufacturer Narrative

The lot number was not provided, therefore, the device history records could not be reviewed.The device has not been returned to the manufacturer for eval.The investigation is currently underway.

Manufacturer Narrative

A manufacturing review could not be performed as the lot number was not provided.The denali filter was returned.Five electronic photos were provided.Based on the returned sample condition, the investigation is confirmed for two crossed legs upon retrieval.It is unknown if the legs were crossed while implanted as procedural images were not provided.Based on the information provided, the definitive root cause is unknown.It is unknown if patient and/or procedural factors contributed to this event.Photo review: five (5) electronic photos were reviewed by (b)(6).All five photos show a denali filter with all 6 arms and legs present and intact.Clot/tissue appears to be binding two legs together.It is unknown from the photos provided if the limbs are crossed or simply bound together by the clot/tissue.Based on the photos provided, crossed limbs cannot be confirmed.The current ifu (instructions for use) states: warning/ precautions/ 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.Do not attempt to remove the denali filter if significant amounts of thrombus are trapped within the filter or if the filter snare hook is embedded within the cava wall.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 at anytime during this procedure.Failure of filter expansion/incomplete expansion.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 filter retrieval, the filter was retrieved successfully; however, two crossed filter legs were identified with fibrine tissue attached.There were no reported difficulties retrieving the filter.There was no reported patient injury.

Manufacturer Narrative

Patient details, implant/explant dates and reason for filter placement were received from the customer facility.

Event Description

New information: it was reported that approximately one month post vena cava filter deployment for pe, two filter legs were discovered to be crossed with "fibrin" on it.It is unknown if the filter legs were known to be crossed prior to the retrieval of the filter.There was no reported impact or consequence to the patient.

• Brand Name: DENALI FEMORAL SYSTEM
• 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 2045
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4902737
• MDR Text Key: 6830325
• Report Number: 2020394-2015-00991
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,for
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DL900F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 50 YR