MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Reocclusion (1985)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

The sample was not returned from the user facility; therefore, device evaluation was 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.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 will all relevant information.

Event 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 superficial femoral artery (sfa).Approximately 4 months after the index procedure, the patient¿s 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.

Manufacturer Narrative

Upon receipt of additional information, this complaint is now reportable to the fda.H10: manufacturing review: the sample was not returned by the user facility.Lot history review revealed there are a total of 5 complaints for lot gfzg1984 all five of the complaints are 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 the patient¿s right sfa vasculature was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study device and not related to 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.H11:section a through f - the information provided by bd 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 bd.

Event 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 superficial femoral artery (sfa).Approximately 4 months after the index procedure, the patient¿s right sfa vasculature was reportedly reoccluded and patient experienced edema.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the device and not related to procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.

Manufacturer Narrative

H10: upon receipt of additional information, this complaint is no longer reportable to the fda.H10: manufacturing review: the sample was not returned by the user facility.Lot history review revealed there are a total of 5 complaints for lot gfzg1984 all five of the complaints are 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 the patient¿s right sfa vasculature was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study device and not related to 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.H11:section a through f - the information provided by bd 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 bd.

Event 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 superficial femoral artery (sfa).Approximately 4 months after the index procedure, the patient¿s right sfa vasculature was reportedly reoccluded and patient experienced edema.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the device and not related to procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.

Manufacturer Narrative

Manufacturing review: the sample was not returned by the user facility.Lot history review revealed there are a total of 5 complaints for lot gfzg1984 all five of the complaints are 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 the patient¿s right sfa vasculature was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study device and not related to 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 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 superficial femoral artery (sfa).Approximately 4 months after the index procedure, the patient¿s 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.

Manufacturer Narrative

Manufacturing review: the sample was not returned by the user facility.Lot history review revealed there are a total of 5 complaints for lot gfzg1984 all five of the complaints are 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 the patient¿s right sfa vasculature was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study device and not related to 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 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 superficial femoral artery (sfa).Approximately 4 months after the index procedure, the patient¿s right sfa vasculature was reportedly reoccluded and patient experienced edema.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the device and not related to 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
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 6980365
• MDR Text Key: 90346510
• Report Number: 3006513822-2017-00213
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2017
• Device Model Number: 9004
• Device Catalogue Number: LX351305150
• Device Lot Number: GFZG1984
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 10/07/2019; 10/15/2019; 12/12/2019; 12/13/2019
• Supplement Dates FDA Received: 10/07/2019; 10/15/2019; 12/13/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR