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	02/25/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample(s) were not returned to the user facility; therefore, evaluations of the actual samples are unable to be performed.A lot history review revealed 5 additional reocclusion complaints were associated with the same clinical site utilizing this same lot.A review of the device history record (dhr) shows 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, drug or 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 the patient underwent a successful procedure in (b)(6) 2014.Information was provided from the customer that four months post index procedure the patient developed reocclusion of the right superficial femoral artery in the target limb.A new angiogram was completed on (b)(6) 2015.The target limb was assessed to have 95% stenosis.A percutaneous transluminal angioplasty was completed on (b)(6) 2015 with an abbott armada 4x40mm balloon.There was 0% residual stenosis post-revascularization.The re-vascularization was said to be successful.The patient has a history of chronic renal insufficiency, liver cirrhosis, hypertension, hyperlipidemia, diabetes mellitus, is a current smoker, and a family history of peripheral vascular disease, coronary artery disease, peripheral artery disease.Subject's relevant post-procedure concomitant medications include lipid modifying agents, thrombosis 100mg (aspirin), plavix 75mg.The subject was also on these medications at the 1 month followup visit.No patient injury was initially reported.

• 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: 5511604
• Report Number: 3006513822-2016-00060
• Device Sequence Number: 340732
• Product Code: ONU
• UDI-Device Identifier: 00801741088469
• UDI-Public: (01)00801741088469(17)151030(10)GFYE2411
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2015

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: 10/30/2015
• Device Model Number: 9004
• Device Catalogue Number: 9020410400150
• Device Lot Number: GFYE2411
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2016
• 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: 64 YR
• Patient Weight: 65