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	06/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 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 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 distal superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient¿s right distal sfa vasculature was reportedly reoccluded.A revascularization was performed on (b)(6) 2017 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
H10: manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Investigation summary: 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 a reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
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 distal superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient¿s right distal sfa vasculature was reportedly reoccluded.A revascularization was performed on (b)(6) 2017 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 through a clinical study, approximately 2 years post index procedure, an occlusion or restenosis (50-99%) in the target lesion has been reported.It was further reported that approximately 2 years and 10-month post index procedure, patient experienced occlusion in the target lesion.No further action was reported by site.The study was completed.
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 distal superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient¿s right distal sfa vasculature was reportedly reoccluded.A revascularization was performed on (b)(6) 2017 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 through a clinical study, approximately 2 years post index procedure, an occlusion or restenosis (50-99%) in the target lesion has been reported.It was further reported that approximately 2 years and 10-month post index procedure, patient experienced occlusion in the target lesion.No further action was reported by site.The study was completed.
Additional Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Investigation summary: 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 a reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

• 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: 6867285
• Report Number: 3006513822-2017-00177
• Device Sequence Number: 19007550
• Product Code: ONU
• UDI-Device Identifier: 00801741088742
• UDI-Public: (01)00801741088742
• 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): 06/28/2019

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: 09/30/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351304150
• Device Lot Number: GFZI0599
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/14/2019; 06/14/2019
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 06/28/2019; 06/28/2019
• 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: 64 YR
• Patient Weight: 115