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	03/31/2016
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 9 additional reocclusion complaints are 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 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 12 months after the index procedure on (b)(6) 2015, the patient¿s right sfa vessel was reportedly reoccluded.No additional intervention was performed at that time.On (b)(6) 2017, approximately 30 months after index procedure, the site reported that the subject underwent a revascularization procedure.The reintervention involved a cordis savvy balloon, followed by two abbott supera stents.The investigator assessed that the event was unlikely related to the study device or procedure.The sample was discarded by the user facility and not available for further 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 3006513822-2017-00200.
Event or Problem Description
It was reported 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 12 months after the index procedure on (b)(6) 2015, the patient¿s right sfa vessel was reportedly reoccluded.No additional intervention was performed at that time.On (b)(6) 2017, approximately 30 months after index procedure, the site reported that the subject underwent a revascularization procedure.The reintervention involved a cordis savvy balloon, followed by two abbott supera stents.The investigator assessed that the event was unlikely related to the study device or procedure, but the cec has adjudicated the study device to be possibly related.The sample was discarded by the user facility and is not available for further 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 3006513822-2017-00200.
Additional Manufacturer Narrative
Additional information: the event description had the following phrase added: "but the cec has adjudicated the study device to be possibly related." conclusion the conclusion had the following phrase added: "but the cec has adjudicated the study device to be possibly related." corrected data: the operator of device - other field was changed from "na" to nothing.The eval codes were changed to align with guidance that was received from the fda.The following method codes were changed from: 3263, 3317 to 4115, 3331, and 4110.The following conclusion code was changed from 92 to 4310.The samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 9 additional reocclusion complaints are 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, but the cec has adjudicated the study device to be possibly related.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.

• 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: 6968304
• Report Number: 3006513822-2017-00199
• Device Sequence Number: 1090988
• Product Code: ONU
• UDI-Device Identifier: 00801741088476
• UDI-Public: (01)00801741088476
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/16/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2016
• Device Model Number: 9004
• Device Catalogue Number: 9020410500150
• Device Lot Number: GFYE0192
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 07/16/2018
• 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: 82 YR
• Patient Weight: 75