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	02/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 4 additional 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 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 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, three 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 10 months after the index procedure, the patient¿s entire right sfa vasculature 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 is not available for evaluation.No adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2017-00233 and 3006513822-2017-00234.
Additional Manufacturer Narrative
Additional information: patient weight and weight units, 82 kgs, were added.Eval code & desc - results code 213 was added.Corrected information: date of event was changed from "on (b)(6) 2016" to "on (b)(6) 2016".Event description was changed from "it was reported through a clinical registry that during the index procedure, three 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 10 months after the index procedure, the patient¿s entire right sfa vasculature 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 is not available for evaluation.No adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2017-00233 and 3006513822-2017-00234." to: "it was reported through a clinical registry that during the index procedure, three 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 1 month after the index procedure, the patient¿s entire right sfa vasculature 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 is not available for evaluation.No adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2017-00233 and 3006513822-2017-00234." relevant tests and lab data was changed from "unknown" to "duplex ultrasound images on (b)(6) 2016, resulting in 50-99% occlusion.Target lesion reintervention on (b)(6) 2016." other relevant history was changed from "patient weight is unavailable." to "past medical history includes: type ii diabetes, dyslipidemia, hypertension, current cigarette smoker, cad, myocardial infarction (2001), rutherford class iii in right leg." mdr contact person and email address was changed from "(b)(6)" respectively.Phone number was changed from "(b)(6)".Eval code & desc - method codes were changed from "3263 and 3317" to "4115, 4110, and 3331".Eval code & desc - conclusion code was changed from "92" to "4310".Device evaluated by mfr analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 4 additional 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 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 will all relevant information.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, three 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 1 month after the index procedure, the patient¿s entire right sfa vasculature 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 is not available for evaluation.No adverse patient effects were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2017-00233 and 3006513822-2017-00234.

• 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: 6985094
• Report Number: 3006513822-2017-00235
• Device Sequence Number: 1227754
• Product Code: ONU
• UDI-Device Identifier: 00801741088599
• UDI-Public: (01)00801741088599
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/18/2019

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: 08/19/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130560
• Device Lot Number: GFZH2229
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/18/2019
• 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: 57 YR
• Patient Weight: 82