MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX; 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	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, the device evaluation was not unable to be performed.Lot history review revealed there are a total of 7 complaints for lot gfzg3808.Six of the complaints are related to the allegation of reocclusion.One complaint is not related to this event.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.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 re-occlusion 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 right proximal superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time, but the patient is on a medication regiment.The investigator assessed that the event was possibly related to the study device, but not the procedure.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected data: adverse event report type was changed from "adverse event + product problem" to "adverse event." outcomes attributed to adv ev was changed from "n/a" to "required intervention to prevent permanent impairment/damage (devices)." event description was changed from "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 proximal superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time, but the patient is on a medication regiment.The investigator assessed that the event was possibly related to the study device, but not the procedure.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported." to "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 proximal superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.No additional intervention was performed at that time, but the patient was put on a medication regiment.Approximately 11 months after the index procedure, 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 further evaluation.No adverse patient effects were reported." relevant tests and lab data was changed from "na" to "on (b)(6) 2017, a reintervention was performed involving the placement of a stent." device returned to mfg? was changed from "yes" to "no." analysis: the following excerpt ".Was not unable to be performed.Lot history." was changed to ".Was unable to be performed.A lot history." additional data: model no."9004" was added.Analysis: the sample was not returned from the user facility; therefore, the device evaluation was unable to be performed.A lot history review revealed there are a total of (b)(4) complaints for lot gfzg3808.(b)(4) of the complaints are related to the allegation of reocclusion.One complaint is not related to this event.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.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 re-occlusion 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, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the right proximal superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s right proximal sfa vessel was reportedly reoccluded.No additional intervention was performed at that time, but the patient was put on a medication regiment.Approximately 11 months after the index procedure, 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 further evaluation.No adverse patient effects were reported.

• Brand Name: LUTONIX
• 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: 6974228
• Report Number: 3006513822-2017-00205
• Device Sequence Number: 10873641
• Product Code: ONU
• UDI-Device Identifier: 00801741088742
• UDI-Public: (01)00801741088742
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613400150
• Device Lot Number: GFZG3808
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 01/08/2018
• 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: 58 YR
• Patient Weight: 60