MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Type  Injury  

Manufacturer Narrative

Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.The lot history review could not be conducted because the lot number, although requested, was not available from the user facility.The dhr review also was not conducted because the facility did not provide the lot number.Conclusion: the actual samples were not returned for evaluation.The dhr review was not conducted because the facility did not provide the lot number.Based on the instructions for use (ifu), the occurrence of reocclusion and claudication are inherent risks of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

Event Description

It was reported through a literature article that during the index procedure, three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion in the superficial femoral artery (sfa) and popliteal artery.Approximately 6 months after the index procedure, the patient was re-examined due to right calf claudication after walking 100 meters.A new duplex ultrasound (dus) revealed greater than 75% reocclusion just proximal to the eluvia stent which was placed due to a dissection occurring after the use of lutonix dcb's during the index procedure.The health care professional (hcp) presumed the reocclusion was a result of neointimal hyperplasia from balloon trauma, given that there was no clinical or biochemical evidence of an acute inflammatory flare of giant cell arteritis (gca).In the opinion of the investigator, the occurrence of reocclusion is possibly related to the lutonix dcb.The remainder of the sfa and stent appeared widely patent with no significant stenosis.An angioplasty procedure is planned involving the use of dcb's.The lutonix dcb's were discarded by the user facility and are not available for return.No adverse patient outcomes were reported.This is one of three products involved with the reported event and the associated manufacturer¿s report numbers are 3006513822-2019-00034 and 3006513822-2019-00035.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 8388658
• MDR Text Key: 137837032
• Report Number: 3006513822-2019-00036
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: 9040413500150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR