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	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The investigation is currently under review.
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 popliteal artery and femoral artery.Approximately 2 months after the index procedure, the target lesion was reportedly reoccluded, and the patient experienced the right first toe pains.A revascularization was not performed, because of its difficulty, based on the decision by health care professional (hcp).An amputation procedure of the right leg above the knee was performed.The investigator assessed that the event was not related to the study device or procedure.
Additional Manufacturer Narrative
H10: manufacturing review: the sample was not returned by the facility for further evaluation.Lot history review revealed this is only complaint for lot number gfcn2055.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 that approximately 2 months post index procedure, the target lesion was reportedly reoccluded and the patient experienced pain in right first toe, but a revascularization on the target lesion was not performed because the hcp determined it was too difficult.Therefore, the hcp elected to do an above the knee amputation.The physician deemed the reocclusion event, that led to an elective above the knee amputation, to be not related to the study device.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 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 popliteal artery and femoral artery.Approximately 2 months after the index procedure, the target lesion was reportedly reoccluded, and the patient experienced the right first toe pains.A revascularization was not performed, because of its difficulty, based on the decision by health care professional (hcp).An amputation procedure of the right leg above the knee was performed.The investigator assessed that the event was not related to the study device or procedure.

• 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: 9187061
• Report Number: 3006513822-2019-00125
• Device Sequence Number: 2811718
• Product Code: ONU
• UDI-Device Identifier: 00801741123184
• UDI-Public: (01)00801741123184
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 01/18/2021
• Device Model Number: 9004
• Device Catalogue Number: LX3513041505F
• Device Lot Number: GFCN2055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 44