MAUDE Adverse Event Report: LUTONIX INC. LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 12/11/2014

Event Type  Injury  

Event Description

It was reported this lutonix drug coated balloon (dcb) catheter was successfully used to treat an in-stent re-stenosis of the proximal to distal superficial femoral artery (sfa).Arterial access was gained via the femoral artery and an introducer was placed in a contra lateral approach.A 0.035" guide wire was used to successfully gain access to the lesion.Four lutonix dcb catheters were then prepared and successfully inflated at the target lesion without difficulty.Three days later, the patient allegedly presented to the hospital with a swollen leg (target limb).The health care provider reported the patient was admitted to the hospital and treated with steroids, which the patient responded positively.The swelling reoccurred when the steroids were withdrawn from medical management.Reportedly, three weeks later, the patient was discharged after the swelling was resolved.The health care provider reported there were no procedural complications and the hospitalization was not a result of cellulitis, deep vein thrombosis, re-occlusion, or vessel damage, rather due to an allergic reaction to an unknown cause.This is one of four products involved with the reported event and are associated manufacturers report numbers 3006513822-2015-00004, 3006513822-2015-00005, 3006513822-2015-00006.

Manufacturer Narrative

The sample was not returned; therefore, evaluation was not able to be performed.The lot history records were reviewed with special attention to the manufacturing and inspection of this product and were found to have met all specifications prior to being released for distribution.In reviewing the labeling supplied with this product, it was found that the instructions for use (ifu) sufficiently address the potential factors.The ifu states "potential adverse events which may be associated with a peripheral balloon dilatation procedure include: inflammation".Conclusion: potential factors that could have led or contributed to the reported event have been considered.Based on the information provided by the user facility and manufacturing review, a definitive root cause for the reported event could not be determined.It is unknown if patient physiology or an adverse reaction(s) with other device/medications from the procedure could have contributed to the event.The patient was treated with steroids and released from the hospital.A review of our quality database noted this event is an isolated occurrence.There have been no other events reported for leg swelling post lutonix dcb pta treatment.Lutonix continues to monitor the field performance of this device to detect similar events, should they occur.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX INC.; new hope MN
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay rd.; queensbury NY 12804 204
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634452364
• MDR Report Key: 4514812
• MDR Text Key: 5488164
• Report Number: 3006513822-2015-00003
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2016
• Device Model Number: 9004
• Device Catalogue Number: LX35130640
• Device Lot Number: GFYI3435
• Other Device ID Number: (01)00801741088568(17)160925(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR