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	08/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, device evaluation is unable to be performed.A lot history review revealed 4 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.Although requested, patient weight was unavailable.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.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, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the right proximal superficial femoral artery (sfa).Approximately 13 months after the index procedure, the patient¿s right proximal sfa (b)(6)2017.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.Although requested, patient weight was unavailable.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected information: the event description was corrected from "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 proximal superficial femoral artery (sfa).Approximately 13 months after the index procedure, the patient¿s right proximal sfa (b)(6) 2017.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.Although requested, patient weight was unavailable.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported." to "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 proximal superficial femoral artery (sfa).Approximately 13 months after the index procedure, the patient¿s right proximal sfa was reportedly reoccluded on (b)(6) 2017 via a duplex ultrasound imaging.A revascularization was performed on (b)(6) 2018 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." analysis: the sample was not returned from the user facility; therefore, device evaluation is unable to be performed.A lot history review revealed 4 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.Although requested, patient weight was unavailable.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 proximal superficial femoral artery (sfa).Approximately 13 months after the index procedure, the patient¿s right proximal sfa was reportedly reoccluded on (b)(6) 2017 via a duplex ultrasound imaging.A revascularization was performed on (b)(6) 2018 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.
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed there are a total of 6 complaints for the corporate lot number luar0094.All six of the complaints are for the allegation of reocclusion.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 user facility.Evaluation could not be performed.Past medical history includes type 2 diabetes, dyslipidemia, hypertension, former smoker, history of cardiovascular disease (coronary artery disease (cad), myocardial infarction in 2014), rutherford class v.It was reported approximately 13 months after the index procedure, the patient¿s right proximal sfa was reportedly reoccluded on (b)(6) 2017 via a duplex ultrasound imaging.A revascularization was performed on (b)(6) 2018 and the hcp deemed it was successful.Additionally, 2-year 8-month after the index procedure, a duplex ultrasound concluded the target lesion is patent, two days later another duplex ultrasound was performed noting 60% occlusion of the target lesion.It was further reported, a revascularization was performed that day to treat the 60% occluded lesion.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.The root cause of the reocclusion is inconclusive, reocclusion was not device related.
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 proximal superficial femoral artery (sfa).Approximately 13 months after the index procedure, the patient¿s right proximal sfa was reportedly reoccluded on (b)(6) 2017 via a duplex ultrasound imaging.A revascularization was performed on (b)(6) 2018 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.New information: it was reported that approximately 2-year 8-month post index procedure, reocclusion was identified via ultrasound.It was further reported that 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 7856451
• Report Number: 3006513822-2018-00190
• Device Sequence Number: 1431473
• Product Code: ONU
• UDI-Device Identifier: 00801741088766
• UDI-Public: (01)00801741088766
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 07/16/2019

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: 01/04/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351306150
• Device Lot Number: LUAR0094
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/09/2018; 07/12/2019
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/10/2018; 07/16/2019
• 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: 62 YR
• Patient Weight: 100