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	12/03/2018
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 there are a total of four (4) complaints for corporate lot number gfap1750.All four (4) complaints are related to an allegation of reocclusion, which includes this complaint.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 approximately 27 months post index procedure, the patient¿s left sfa was reportedly reoccluded via dus imaging and a revascularization was performed.Approximately 36 months post index procedure, the patient¿s left sfa was reportedly reoccluded again via dus imaging and a revascularization was performed.The investigator assessed that the event was not related to the study device or procedure.However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s).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 lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left superficial femoral artery (sfa).Approximately 27 months post index procedure, the patient¿s left sfa was reportedly reoccluded via duplex ultrasound imaging and intervention was performed.It was further reported that during 36-month follow-up post index procedure, reocclusion was identified via imaging and intervention was performed.

• 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: 9163684
• Report Number: 3006513822-2019-00124
• Device Sequence Number: 11297479
• Product Code: ONU
• UDI-Device Identifier: 00801741123191
• UDI-Public: (01)00801741123191
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/07/2019

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: 02/28/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351305405F
• Device Lot Number: GFAP1750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/07/2019
• 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: 55 YR
• Patient Weight: 88