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	02/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 6 additional reocclusion complaints 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, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the left mid superficial femoral artery (sfa) and left mid popliteal artery.Approximately 13 months after the index procedure, the patient¿s target lesions were reportedly reoccluded via duplex ultrasound (dus) imaging.The registry's independent evaluator assessed that both target lesions were patent at this time.Approximately 28 months after the index procedure, a clinically driven revascularization was performed on the target lesion located in the left mid sfa only.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.
Additional Manufacturer Narrative
Additional information: b.5: the event description had the following statements added, "approximately one month after the revascularization on left mid sfa, a revascularization was performed on left mid popliteal artery, target lesion 1." and "this is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2019-00081." b.6: the relevant tests and lab data had the following added, "on (b)(6) 2018, reintervention was performed on target lesion 1, left mid popliteal artery.On (b)(6) 2018, dus imaging indicated 50-99% occlusion of target lesions." corrected data: b.5: the event description had the following sentences changed: "approximately 28 months after the index procedure, a clinically driven revascularization was performed on the target lesion located in the left mid sfa only." to "approximately 28 months after the index procedure, a clinically driven revascularization was performed on target lesion 2, left mid sfa." and "the health care professional (hcp) deemed it was successful." to "the health care professional (hcp) deemed both revascularizations were successful." h3 analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 6 additional reocclusion complaints associated with this lot.A review of the device history record (dhr) indicates 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 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, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the left mid superficial femoral artery (sfa) and left mid popliteal artery.Approximately 13 months after the index procedure, the patient¿s target lesions were reportedly reoccluded via duplex ultrasound (dus) imaging.The registry's independent evaluator assessed that both target lesions were patent at this time.Approximately 28 months after the index procedure, a clinically driven revascularization was performed on target lesion 2, left mid sfa.Approximately one month after the revascularization on left mid sfa, a revascularization was performed on left mid popliteal artery, target lesion 1.The health care professional (hcp) deemed both revascularizations were 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 manufacturer¿s report number is 3006513822-2019-00081.

• 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: 8081953
• Report Number: 3006513822-2018-00266
• Device Sequence Number: 268704
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/17/2019

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: 09/10/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351305150
• Device Lot Number: GFZI1289
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 05/17/2019
• 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: 65 YR
• Patient Weight: 77