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

Model Number	9001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: lot history review revealed there are a total of two (2) complaints for corporate lot number gfbt1685.Both complaints are for 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: inconclusive.The sample was discarded by the user facility; therefore, the device evaluation cannot be performed.Past medical history includes: hypertension, diabetes (type unknown), chronic renal disease, rutherford class iii in right leg.It is known that approximately 8 months post treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter reocclusion was identified in the right femoral artery.It was further reported that a reintervention involving placement of a stent was performed.The physician deemed the event is possibly related to device, but not related to procedure.No adverse patient effects were reported.Labeling 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 post market clinical study 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 right femoral artery.Approximately 8 months after the index procedure, the patient¿s right femoral artery was reportedly reoccluded.A revascularization was performed and health care professional (hcp) deemed it was successful.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.The sample was discarded by the user facility and is not available for evaluation.

• 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: 9511770
• Report Number: 3006513822-2019-00140
• Device Sequence Number: 388597
• Product Code: ONU
• UDI-Device Identifier: 00801741123146
• UDI-Public: (01)00801741123146
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 06/16/2020
• Device Model Number: 9001
• Device Catalogue Number: LX351304605F
• Device Lot Number: GFBT1685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/23/2019
• 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: 74 YR
• Patient Weight: 67