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	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed (b)(4) additional reocclusion complaints were associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was not related to the study device or procedure.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.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
Event or Problem Description
It was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 16 months after the index procedure, the patient¿s target lesion in the right mid sfa was reportedly reoccluded via duplex ultrasound (dus) imaging.A clinically driven 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.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Event or Problem Description
It was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 16 months after the index procedure, the patient¿s target lesion in the right mid sfa was reportedly reoccluded via duplex ultrasound (dus) imaging.A clinically driven 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.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.New information: it was reported that approximately 26 months posy index procedure, an occlusion or restenosis was identified via imaging.It was further reported that approximately 28 months post index procedure, an occlusion was identified via imaging.No intervention was performed.
Additional Manufacturer Narrative
H10: manufacturing review: the sample was not returned by the facility for further evaluation.Lot history review revealed there are a total of 3 complaints related to the corporate lot number gfzj1372.All three of the total complaints were reported for the allegation of reocclusion.The 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 16 months after the index procedure, the patient¿s target lesion in the right mid sfa was reportedly reoccluded via duplex ultrasound (dus) imaging.A clinically driven 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.Approximately 26 months after the index procedure, the patient¿s target lesion in the right mid sfa was reportedly reoccluded via dus imaging following the revascularization that was performed 8 months prior.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.Label review: 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.

• 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: 7995552
• Report Number: 3006513822-2018-00237
• Device Sequence Number: 18904380
• Product Code: ONU
• UDI-Device Identifier: 00801741088629
• UDI-Public: (01)00801741088629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/24/2019

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: 10/05/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130480
• Device Lot Number: GFZJ1372
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/24/2019
• 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: 68 YR
• Patient Weight: 82