MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUIG COATED BALLOON PTA CATHETER; 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	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned by the user facility.The 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 user facility.It is known that approximately 11 months after the index procedure, the patient¿s sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time.The investigator assessed that the event was not related to the study device or procedure.It was reported that approximately 30 months post index procedure, target lesion stenosis was identified.It was further reported that revascularization was performed with successful result.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported 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, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left mid superficial femoral artery (sfa).Approximately 11 months after the index procedure, the patient¿s left mid sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time.The investigator assessed that the event was not related to the study device or procedure.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.New information: it was reported that approximately 30 months post index procedure, target lesion stenosis was identified.It was further reported that revascularization was performed with successful result.

• Brand Name: LUTONIX 035 DRUIG 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: 9397217
• Report Number: 3006513822-2019-00135
• Device Sequence Number: 19559105
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/02/2019

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: Other
• Device Expiration Date: 05/03/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFAR3870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/02/2019
• 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: 73 YR
• Patient Weight: 87