MAUDE Adverse Event Report: LUTONIX, INC 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	07/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The samples were not returned from the user facility; therefore, device evaluations were unable to be performed.A lot history review revealed this is the only reocclusion complaint 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.
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 lesion located in the right superficial femoral artery (sfa).Approximately 9 months after the index procedure, the patient¿s right sfa vasculature was reportedly reoccluded.On (b)(6) 2016, approximately two months after the initial reintervention, an additional intervention was completed.The 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 two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2017-00232.
Additional Manufacturer Narrative
Additional information: weight (b)(6).Corrected data: other relevant history was changed from "patient weight is unavailable" to "n/a." the samples were not returned from the user facility; therefore, device evaluations were unable to be performed.A lot history review revealed this is the only reocclusion complaint 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.
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 lesion located in the right superficial femoral artery (sfa).Approximately 9 months after the index procedure, the patient¿s right sfa vasculature was reportedly reoccluded.On (b)(6) 2016, approximately two months after the initial reintervention, an additional intervention was completed.The 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 two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2017-00232.
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 superficial femoral artery (sfa) and left popliteal artery.Approximately 9 months after the index procedure, the patient¿s left sfa and left popliteal vasculature were reportedly reoccluded.On (b)(6) 2016, approximately two months after the initial reintervention, an additional intervention was completed.The 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.New information: it was reported through a clinical study that approximately 27 months post index procedure, re-intervention was performed.
Additional Manufacturer Narrative
Additional information: a.4 weight "163" a.4 weight units "lbs".Corrected data: b.7 other relevant history was changed from "patient weight is unavailable" to "n/a." h3 analysis: the samples were not returned from the user facility; therefore, device evaluations were unable to be performed.A lot history review revealed this is the only reocclusion complaint 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.H11:section a through f - 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.
Additional Manufacturer Narrative
Manufacturing review: the sample was not returned by the user facility.Lot history review revealed there is a total of one complaint for lot gfzb2547 related to the allegation of reocclusion.The 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.It is known that approximately 9 months after the index procedure, the patient¿s left sfa and left popliteal vasculature were reportedly reoccluded.Approximately two months after the initial reintervention, an additional intervention was completed.The 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.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.Label review: 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.
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 superficial femoral artery (sfa) and left popliteal artery.Approximately 9 months after the index procedure, the patient¿s left sfa and left popliteal vasculature were reportedly reoccluded.On (b)(6) 2016, approximately two months after the initial reintervention, an additional intervention was completed.The 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.New information: it was reported through a clinical study that approximately 27 months post index procedure, re-intervention was performed.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 6984437
• Report Number: 3006513822-2017-00231
• Device Sequence Number: 497926
• Product Code: ONU
• UDI-Device Identifier: 00801741088544
• UDI-Public: (01)00801741088544
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/02/2019

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: 02/19/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130440
• Device Lot Number: GFZB2547
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/21/2017; 11/08/2019; 11/08/2019
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/12/2018; 11/26/2019; 12/02/2019
• 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: 74