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	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: lot history review revealed there are two (2) total complaints for corporate lot number gfbv4115.Both of the complaints are related to 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: the sample was not returned by the facility for further evaluation.It is known that approximately 6 months post index procedure, the target lesion was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.No adverse patient outcomes were reported.However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s).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 femoral artery.Approximately 6 months after the index procedure, the patient¿s right femoral artery was reportedly reoccluded.A revascularization was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.
Additional Manufacturer Narrative
H10: manufacturing review: lot history review revealed there are two (2) total complaints for corporate lot number gfbv4115.Both of the complaints are related to 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: the sample was not returned by the facility for further evaluation.It is known that approximately 6 months post index procedure, the target lesion was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device, but possibly related to the procedure.No adverse patient outcomes were reported.However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s).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.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 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 6 months after the index procedure, the patient¿s right femoral artery was reportedly reoccluded.A revascularization was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was not related to the study device but possibly related to the 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: 9106686
• Report Number: 3006513822-2019-00119
• Device Sequence Number: 1924304
• Product Code: ONU
• UDI-Device Identifier: 00801741122811
• UDI-Public: (01)00801741122811
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 09/05/2020
• Device Model Number: 9004
• Device Catalogue Number: LX35755605F
• Device Lot Number: GFBV4115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 57