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

Catalog Number DL950F

Device Problems Bent (1059); Difficult to Remove (1528)

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

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us.The pro code and 510 k number for the denali vena cava filter products are identified respectively.No device, no medical records, or no medical images were provided to the manufacturer.A photo of the device was provided and is under review.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.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 that approximately six months post vena cava filter deployment, the filter was allegedly difficult to remove with a snare retrieval device.It was further reported that the health care provider snared the body of the filter but could not remove it through the sheath; therefore, a surgical cut down was performed and the filter was retrieved.Upon retrieval, one of the filter limbs was allegedly bent.The patient was reported as doing well.

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the denali vena cava filter products that are cleared in the us.The pro code and 510 k number for the denali vena cava filter products are identified respectively.Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided for review.An image was provided and reviewed.A bent filter leg could be identified in the photo.A clot around the base of the apex and hook could also be identified.Therefore, based off the photo review, the investigation can be confirmed for a bent filter limb.However, the investigation is inconclusive for difficulty to remove.Per the reported event details, the surgeons open approach had caused the filter leg to bend.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.

Event Description

It was reported that approximately six months post vena cava filter deployment, the filter was allegedly difficult to remove with a snare retrieval device.It was further reported that the health care provider snared the body of the filter but could not remove it through the sheath; therefore, a surgical cut down was performed and the filter was retrieved.Upon retrieval, one of the filter limbs was allegedly bent.The patient was reported as doing well.

• 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
• 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: 7394434
• MDR Text Key: 104249800
• Report Number: 2020394-2018-00336
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040825
• UDI-Public: (01)00801741040825
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DL950F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention