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

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned by the facility for further evaluation.Lot history review revealed this is the only complaint for corporate lot number luze0013.A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned by the facility for further evaluation.It is known that the patient was scheduled for a peripheral angiogram and approximately 13 months post index procedure, had a revascularization and was deemed successful.The location of the occlusion was requested, but the information was not available from the study site as the patient has completed their study protocol.Label review: based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, a percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesions in the mild and distal 1/3 of superficial femoral artery (sfa).It was reported that approximately 13 months post index procedure, patient developed stenosis.Re-intervention was performed.It was further reported that approximately 3-year one month post index procedure, severe stenosis was identified via duplex ultrasound at the target limb.It was further reported that the patient was scheduled for a peripheral angiogram.The site determined the relationship to the device as possibly related and relationship to the procedure was not provided.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9216072
• Report Number: 3006513822-2019-00129
• Device Sequence Number: 16240115
• Product Code: ONU
• UDI-Device Identifier: 00801741088766
• UDI-Public: (01)00801741088766
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351306150
• Device Lot Number: LUZE0013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR