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

Catalog Number DL900F

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033); Swelling (2091); Urticaria (2278)

Event Date 06/17/2015

Event Type  Injury  

Event Description

It was reported that following a successful vena cava filter deployment for a scheduled oophorectomy.The same evening of the filter implant, the patient developed systemic swelling and itching.Reportedly, the surgeon recommended over the counter medication.The next morning the patient presented to the er with increased swelling and rash and the er physician suggested the reaction could be due to contrast.That same day the patient visited her primary care physician who reportedly referred her to an allergist who; according to the patient, will conclusively provide a diagnosis.Per patient, symptoms have subsided with continued use of over the counter antihistamine.

Manufacturer Narrative

The lot number has been provided and the device history records are being reviewed.The investigation 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.

Manufacturer Narrative

Manufacturing review is ongoing and investigation is in progress.(b)(4).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

A manufacturing review was performed.The lot met all release criteria.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: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.It was reported by the patient, that the emergency room physician thought the patients symptoms (itchiness, swelling, and rash) were likely due to the contrast used during the filter deployment.The physician that deployed the filter also believed the reaction was due to the contrast, not the filter.It is unknown if allergy testing will be performed.The investigation is inconclusive for patient-device incompatibility.The patient alleged itchiness, rash, and swelling occurred immediately after deployment and retrieval of the vena cava filter.The patient reported that she had no symptoms approximately one month post deployment while the filter was still implanted.Therefore, the reaction was likely caused by the contrast during implantation and explantation.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: the denali filter consists of twelve shape-memory laser-cut nickel-titanium appendages.Contraindications for use: - patients with known hypersensitivity to nickel-titanium alloys.Warnings: - the denali filter consists of nickel-titanium alloy, which is generally considered safe.However, in vitro testing has demonstrated that nickel is released from this device.Persons with allergic reactions to nickel may suffer an allergic response to this implant, especially those with a history of metal allergies.Some patients may develop an allergy to nickel if this device is implanted.Certain allergic reactions can be serious.While devices that release nickel are not expected to result in symptoms such as difficulty in breathing or inflammation of the face or throat, if these types of allergic reactions occur, patients should be instructed to seek immediate medical attention.

• 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: 4925747
• MDR Text Key: 6433464
• Report Number: 2020394-2015-01166
• 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,Company Representative,company representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/17/2015

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: 05/31/2018
• Device Catalogue Number: DL900F
• Device Lot Number: GFZD4274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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: 45 YR
• Patient Weight: 68