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	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: the sample was not returned by the facility for further evaluation.It is known that the patient¿s left popliteal and sfa vasculature were reportedly reoccluded via dus imaging and a re-intervention was performed on (b)(6) 2019.The intervention was successful deemed by the hcp.The investigator assessed that the event was not related to the lutonix dcb or to the index procedure.Manufacturing review: the sample was not returned by the facility for further evaluation.A lot history review revealed there are a total of four (4) complaints for corporate lot number gfap2160.Three (3) of the total complaints are for allegations of reocclusion, which includes this complaint.The other complaint is not related to this event.The device history record (dhr) review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.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, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions in the left popliteal artery and left mid superficial femoral artery (sfa).Approximately 24 months after the index procedure, the patient¿s left popliteal and sfa vasculature were reportedly reoccluded via duplex ultrasound (dus) imaging.No revascularization was performed at this time.The investigator assessed that the event was not related to the lutonix dcb's or to the index procedure.The samples were discarded by the user facility and are not available for evaluation.No adverse patient effects were reported.New information: it was further reported that revascularization was performed on the target lesion (mid 1/3 of sfa).

• 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: 9197779
• Report Number: 3006513822-2019-00128
• Device Sequence Number: 2950877
• Product Code: ONU
• UDI-Device Identifier: 00801741123221
• UDI-Public: (01)00801741123221
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 02/24/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513051005F
• Device Lot Number: GFAP2160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/16/2019
• 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: 65 YR
• Patient Weight: 77