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	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The actual sample used during the patient's procedure was not returned to the manufacturer for inspection/evaluation.Based upon the available information, the definitive root cause for this event is unknown; therefore, the investigation surrounding the allegation of reocclusion is inconclusive.The instruction for use (ifu) adequately states general instructions for use, warnings, precautions, and potential complications/adverse events associated with the use of the and experienced during clinical trials involving drug coated balloons.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the left superficial femoral artery (sfa).Approximately 2 year 6-month post index procedure, the patient was experienced reocclusion.It was further reported revascularization was performed to treat the lesion.
Additional Manufacturer Narrative
H10: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The actual sample used during the patient's procedure was not returned to the manufacturer for inspection/evaluation.Based upon the available information, the definitive root cause for this event is unknown; therefore, the investigation surrounding the allegation of reocclusion is inconclusive.The instruction for use (ifu) adequately states general instructions for use, warnings, precautions, and potential complications/adverse events associated with the use of the and experienced during clinical trials involving drug coated balloons.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the left superficial femoral artery (sfa).Approximately 2 year 6-month post index procedure, the patient was experienced reocclusion.It was further reported revascularization was performed to treat the lesion.

• 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: 8798240
• Report Number: 3006513822-2019-00102
• Device Sequence Number: 3082038
• Product Code: ONU
• UDI-Device Identifier: 00801741088766
• UDI-Public: (01)00801741088766
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/19/2019

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: 03/25/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351306150
• Device Lot Number: LUAQ0079
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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: 71 YR
• Patient Weight: 86