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	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates 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 possibly related to the study device, but not related to the 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 with all relevant information.
Event or Problem Description
It was reported through a post market clinical study 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 superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa was reportedly reoccluded.Approximately two weeks later, a revascularization was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Event or Problem Description
It was reported through a post market clinical study 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 superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient¿s right sfa was reportedly 87% reoccluded via duplex ultrasound (dus) imaging.Approximately two weeks later, a revascularization involving a dcb was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was possibly related to the study device, but not related to the procedure.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: event.The event description had the following information changed from "approximately 6 months after the index procedure, the patient¿s right sfa was reportedly reoccluded.Approximately two weeks later, a revascularization was performed and the health care professional (hcp) deemed it was successful." to "approximately 6 months after the index procedure, the patient¿s right sfa was reportedly 87% reoccluded via duplex ultrasound (dus) imaging.Approximately two weeks later, a revascularization involving a dcb was performed and the health care professional (hcp) deemed it was successful." relevant tests/laboratory data: the relevant tests and lab data had the following information changed from "on (b)(6) 2018, reintervention was performed on the target lesion." to "on (b)(6) 2018, dus imaging indicated target lesion was 87% reoccluded.The patient had a resting abi = 0.65 in right leg and a rutherford class assessment of iii in right leg.On (b)(6) 2018, reintervention involving a dcb was performed on the target lesion." initial reporter occupation: the complainant occupation - other had the following information added "cardiovascular internal medicine." device evaluated by mfr analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was possibly related to the study device, but not related to the 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 with 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: 8096318
• Report Number: 3006513822-2018-00273
• Device Sequence Number: 2178916
• Product Code: ONU
• UDI-Device Identifier: 00801741123252
• UDI-Public: (01)00801741123252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 9004
• Device Catalogue Number: LX351306405F
• Device Lot Number: GFBU2932
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 03/25/2019
• 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: 69 YR
• Patient Weight: 70