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	06/02/2017
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 this is the only complaint associated with this lot.A review of the device history record (dhr) shows 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 that the event was possibly related to the study device, but not related to the procedure and the independent evaluator has confirmed the reported reocclusion.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, 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 12 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.A revascularization has been scheduled for (b)(6) 2017.The investigator assessed that the event was possibly related to the study device, but not related to the procedure and the independent evaluator has confirmed the reported reocclusion.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: the event description was changed 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 12 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.A revascularization has been scheduled for july 20, 2017.The investigator assessed that the event was possibly related to the study device, but not related to the procedure and the independent evaluator has confirmed the reported reocclusion.The sample was discarded by the user facility and is not available for 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 catheters was used to treat the target lesion located in the right proximal superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.A revascularization was performed, approximately 20 months after the index procedure, and the hcp deemed it successful.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported." the relevant tests and lab data field was updated from "unknown" to "on (b)(6) 2017, dus imaging indicated 50-99% occlusion of right sfa and core lab analysis of dus imaging on (b)(6) 2017 indicated 50-99% occlusion of right proximal sfa.On (b)(6) 2018, reintervention was performed on the target lesion and 6 other lesions in various vessels." the operator of device - other field was populated with "interventional cardiologist." the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) shows 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 that the event was possibly related to the study device, but not related to the procedure and the independent evaluator has confirmed the reported reocclusion.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.
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 12 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.A revascularization was performed, approximately 20 months after the index procedure, and the hcp deemed it successful.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.

• 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: 6742192
• Report Number: 3006513822-2017-00144
• Device Sequence Number: 10970571
• Product Code: ONU
• UDI-Device Identifier: 00801741088551
• UDI-Public: (01)00801741088551
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 06/01/2018

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: 01/30/2018
• Device Model Number: 9004
• Device Catalogue Number: LX35130540
• Device Lot Number: GFAN0595
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 06/01/2018
• 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: 64 YR
• Patient Weight: 84