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	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned to 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) shows 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 that the event was not related to the study device and possibly related to the 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.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, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left mid superficial femoral artery (sfa).Approximately 9 months after the index procedure, the patient¿s left mid sfa vessel was reportedly reoccluded.A revascularization was performed involving another manufacturers device and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device and possibly related to the procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
H10: manufacturing review: lot history review revealed this is the only complaint for the lot gfap2915.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 left mid sfa vessel was reportedly reoccluded.A revascularization was performed involving another manufacturers device and the hcp deemed it was successful.Approximately 35 months post index procedure, the patient developed reocclusion of the target lesion and a revascularization was performed.The investigator assessed that neither of the reocclusion events were related to the study device, but assessed that the first reocclusion event was possibly related to the index procedure.A definitive root cause could not be determined based on the information provided.It is unknown if 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 or Problem Description
It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left mid superficial femoral artery (sfa).Approximately 9 months after the index procedure, the patient¿s left mid sfa vessel was reportedly reoccluded.A revascularization was performed involving another manufacturers device and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device and possibly related to the 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 that approximately 35 months post procedure, patient developed occlusion at the target lesion and revascularization was performed.
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 catheters were used to treat the target lesion located in the left mid superficial femoral artery (sfa).Approximately 9 months after the index procedure, the patient¿s left mid sfa vessel was reportedly reoccluded.A revascularization was performed involving another manufacturers device and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device and possibly related to the 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 that approximately 35 months post procedure, patient developed occlusion at the target lesion and revascularization was performed.
Additional Manufacturer Narrative
Manufacturing review: lot history review revealed this is the only complaint for the lot gfap2915.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 left mid sfa vessel was reportedly reoccluded.A revascularization was performed involving another manufacturers device and the hcp deemed it was successful.Approximately 35 months post index procedure, the patient developed reocclusion of the target lesion and a revascularization was performed.The investigator assessed that neither of the reocclusion events were related to the study device, but assessed that the first reocclusion event was possibly related to the index procedure.A definitive root cause could not be determined based on the information provided.It is unknown if 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.

• 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: 6554060
• Report Number: 3006513822-2017-00084
• Device Sequence Number: 1010239
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283(17)180331(10)GFAP2915
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/18/2019

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: 03/31/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFAP2915
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2017; 09/10/2019
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 09/17/2019; 09/18/2019
• 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: 50 YR
• Patient Weight: 86