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 Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample was not returned from the user facility; therefore, a device evaluation was unable to be performed.A lot history review revealed 3 additional reocclusion complaints were 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 and 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.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 Description

It was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 2 months after the index procedure, the patient was hospitalized due to left lower extremity arteriosclerosis occlusion.The hcp couldn¿t confirm if the alleged occlusion occurred at the target lesion, since the patient refused diagnostic testing.Reportedly after expressing anxiety, the patient insisted on being discharged the next day after he was admitted to the hospital.Approximately 6 months after the index procedure, the patient was hospitalized and a revascularization was performed.The investigator assessed the event was possibly related to the study device and the procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported.

Manufacturer Narrative

Additional information: b.6 the relevant tests and lab data was updated to include "on (b)(6)2016, cta imaging indicated target lesion was mild to moderately reoccluded.The patient had an abi = 0.94.On (b)(6)2016, patient was prescribed anti-platelet and blood vessel dilation medicine and discharged.On (b)(6)2017, patient was hospitalized for leg pain.On (b)(6)2017, reintervention was performed on the target lesion involving pta and placement of a stent.H.6 the patient code + description had the following code "2550" added.Corrected data: b.5 the event description was changed from "it was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 2 months after the index procedure, the patient was hospitalized due to left lower extremity arteriosclerosis occlusion.The hcp couldn¿t confirm if the alleged occlusion occurred at the target lesion, since the patient refused diagnostic testing.Reportedly after expressing anxiety, the patient insisted on being discharged the next day after he was admitted to the hospital.Approximately 6 months after the index procedure, the patient was hospitalized and a revascularization was performed.The investigator assessed the event was possibly related to the study device and the procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported." to "it was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 2 months after the index procedure, the patient was hospitalized due to left lower extremity arteriosclerosis occlusion.The heath care professional (hcp) confirmed the target lesion was mild to moderately reoccluded by computed tomography angiography (cta).The patient was reportedly prescribed anti-platelet and blood vessel dilation medicine and discharged from the hospital.Approximately 18 months after the index procedure, the patient was admitted to a different hospital for leg pain.A revascularization involving percutaneous transluminal angioplasty (pta) and placement of a stent was performed.The hcp deemed the revascularization was successful.The investigator assessed the event was possibly related to the study device and the procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported." g.1 the mdr contact person and email address was changed from (b)(6) and (b)(6) to (b)(6).G.2 the mdr contact person phone number was changed from (b)(6) to (b)(6).H.6 the eval & desc method codes "3263 and 3317" were changed to "4115, 3331, and 4110" the eval & desc conclusion code "92" was changed to "4310" h.3 analysis conclusion the conclusion had the following sentence changed from "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." to "based on the instructions for use (ifu), the occurrence of reocclusion and/or claudication are inherent risks of any pta procedure." h3 analysis: the sample was not returned from the user facility; therefore, a device evaluation was unable to be performed.A lot history review revealed 3 additional reocclusion complaints were 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 and to the procedure.Based on the instructions for use (ifu), the occurrence of reocclusion and/or 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.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported through a clinical registry 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 mid superficial femoral artery (sfa).Approximately 2 months after the index procedure, the patient was hospitalized due to left lower extremity arteriosclerosis occlusion.The heath care professional (hcp) confirmed the target lesion was mild to moderately reoccluded by computed tomography angiography (cta).The patient was reportedly prescribed anti-platelet and blood vessel dilation medicine and discharged from the hospital.Approximately 18 months after the index procedure, the patient was admitted to a different hospital for leg pain.A revascularization involving percutaneous transluminal angioplasty (pta) and placement of a stent was performed.The hcp deemed the revascularization was successful.The investigator assessed the event was possibly related to the study device and the procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported.

• 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
• MDR Report Key: 7213518
• MDR Text Key: 98019667
• Report Number: 3006513822-2018-00010
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088674
• UDI-Public: (01)00801741088674
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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 Expiration Date: 08/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613500100
• Device Lot Number: GFZG3807
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 71