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	04/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned to the user facility; therefore, evaluation of the actual sample is unable to be performed.A lot history review revealed 1 additional reocclusion or in-stent reocclusion 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 the event was not related to the study device or procedure.Note, the lutonix 035 drug coated balloon pta catheter is indicated for percutaneous transluminal angioplasty (pta), after pre-dilatation of de novo or restenotic lesions up to 150 mm in length in the native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.These lutonix dcb's were used to treat the stented lesion per the study requirements.The occurrence of reocclusion is an inherent risk of any pta procedure.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, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left distal superficial femoral artery (sfa).Approximately 15 months after the index procedure, the patient's left sfa stented area and associated vessels were reportedly reoccluded.A high grade reocclusion of the left common femoral, sfa, and profundus arteries was present.The patient had a successful thrombo-endarterectomy performed on (b)(6) 2015.Even though improved blood flow was evident, the patient complains of strong leg pain; therefore, a minor amputation of digit ii and iii of the left foot was performed.The forefoot and ultimately the lower left leg was amputated on (b)(6) 2016.The investigator assessed the event was not 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.

• 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: 5709804
• Report Number: 3006513822-2016-00129
• Device Sequence Number: 207933
• Product Code: ONU
• UDI-Device Identifier: 00801741088728
• UDI-Public: (01)00801741088728(17)160430(10)GFYD3101
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/20/2016

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: 04/30/2016
• Device Model Number: 9004
• Device Catalogue Number: 9020413600120
• Device Lot Number: GFYD3101
• 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: 06/09/2016
• 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: Disability
• Patient Age: 74 YR
• Patient Weight: 90