MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) 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	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed this is the only reocclusion complaint associated with this lot.A review of the device history record (dhr) shows the lot was manufactured to specification.Conclusion: the actual samples were 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 a 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 will all relevant information.The information provided by bard 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 bard.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the right superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa vessel 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.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00034.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the right proximal-mid superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa vessel 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 devices or procedure.The samples were discarded by the user facility and are not available for further evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00034.
Additional Manufacturer Narrative
Additional information: b.3 the date of the event is updated from "(b)(6) 2016." b.5 the event description was changed from " it was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the right superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa vessel 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.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00034." to "it was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the right proximal-mid superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa vessel 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 devices or procedure.The samples were discarded by the user facility and are not available for further evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00034." b.6 the relevant tests and lab data were updated from "unknown" to "on (b)(6) 2016, dus imaging indicated target lesions were patent.On (b)(6) 2016, dus imaging indicated target lesion were occluded.On (b)(6) 2016, reintervention was performed on target lesions and one non-target lesion within the target vessel.On (b)(6) 2017, dus imaging indicated target lesions were patent and core lab analysis of dus imaging on (b)(6) 2017 confirmed target lesions were patent.B.7 the other relevant history had the following statement added "past medical history includes: current smoker, peripheral artery disease (pad), claudication, glaucoma, reflux, rutherford class iii in right leg." corrected data: d.4 the udi no.Was changed from "(b)(4)." h.6 the eval code and desc section was updated to align with fda guidance effective july 6th, 2018.The method codes "3263 and 3317" were changed to "4115,3331, and 4110." the results code "213" was added.The conclusion code "92" was changed to "4310." h3 analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed this is the only reocclusion complaint associated with this lot.A review of the device history record (dhr) shows the lot was manufactured to specification.Conclusion: the actual samples were not returned 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 devices or procedure.Based on the instructions for use (ifu), the occurrence of a 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 will all relevant information.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 6333133
• Report Number: 3006513822-2017-00033
• Device Sequence Number: 19038171
• Product Code: ONU
• UDI-Device Identifier: 00801741123269
• UDI-Public: (01)00801741123269(17)170216(10)GFAP2920
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/16/2019

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: 02/16/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351306605F
• Device Lot Number: GFAP2920
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 01/16/2019
• 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: 55 YR