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	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instruction for use (ifu) is adequate for the reported device/patient and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 04/2020).
Event or Problem Description
It was reported that during clinical study approximately 5 months and 28 days post treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, subject experienced decreased dialysis dose and reocclusion was identified.It was further reported that re-intervention (standard pta) was performed.The site determined the event is possibly related to device, not related to procedure and possibly related to av access circuit.
Event or Problem Description
It was reported that during clinical study approximately 5 months and 28 days post treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, subject experienced decreased dialysis dose and reocclusion was identified.It was further reported that re-intervention (standard pta) was performed.The site determined the event is possibly related to device, not related to procedure and possibly related to av access circuit.
Additional Manufacturer Narrative
Manufacturing review: lot history review revealed this is the only complaint related to an allegation of reocclusion for corporate lot number gfcn0985.The 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, a device evaluation was not performed.Past medical history includes the following: diabetes type 2, dyslipidemia; hypertension; peripheral arterial/vascular disease (pad/pvd); skin cancer(nose); chronic obstructive pulmonary disease; renal disease, and former smoker.It is known that approximately 5 months and 28 days post treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, subject experienced decreased dialysis dose and reocclusion was identified.It was further reported that re-intervention (standard pta) was performed.The site determined the event is possibly related to device, not related to procedure and possibly related to av access circuit.No further adverse patient outcomes 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.

• 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: 9372593
• Report Number: 3006513822-2019-00134
• Device Sequence Number: 2224383
• Product Code: ONU
• UDI-Device Identifier: 00801741122873
• UDI-Public: (01)00801741122873
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• 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: 04/19/2019
• Device Model Number: 9004
• Device Catalogue Number: LX35756605F
• Device Lot Number: GFCN0985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement 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: 70 YR
• Patient Weight: 109