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 Codes	Reocclusion (1985); No Patient Involvement (2645)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 1 additional reocclusion complaint was associated with the same patient for this 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 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.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s left sfa vessel was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that 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.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00027.
Additional Manufacturer Narrative
Additional information: patient weight was obtained (b)(6) kgs.Analysis: the sample(s) were not returned to the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 1 additional reocclusion complaint was associated with the same patient for this 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 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 through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s left sfa vessel was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that 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.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00027.
Event or Problem Description
It was reported through a clinical registry that during the index procedure, one lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left superficial femoral artery (sfa) and the associated manufacturer report number is 3006513822-2017-00027.Therefore, this record is not reportable because only one lutonix dcb was used during the procedure and it is captured in a different report, 3006513822-2017-00027.
Additional Manufacturer Narrative
The device not evaluated code was updated to "other" the device not eval code-other was updated to "only one lutonix dcb used in procedure, captured in manufacturers report number 3006513822-2017-00027." the outcomes attributed to adv ev was changed from "required intervention to prevent permanent impairment/damage (devices)" to "na".The event description was changed from "it was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left superficial femoral artery (sfa).Approximately 8 months after the index procedure, the patient¿s left sfa vessel was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that 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.This is one of two products involved with the reported event and the associated manufacturers report number is 3006513822-2017-00027." to "it was reported through a clinical registry that during the index procedure, one lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left superficial femoral artery (sfa) and the associated manufacturer report number is 3006513822-2017-00027.Therefore, this record is not reportable because only one lutonix dcb was used during the procedure and it is captured in a different report, 3006513822-2017-00027." the product catalog no.And corporate lot no.Were changed from "lx35130640 and gfza2257" to "unk sfa 035 and na." the.Expiry date and udi no."1/22/2017 and (b)(4)" were removed.The type of reportable event was changed from "serious injury" to "na." the device evaluated was changed from "not returned" to "no." the patient code + description was changed from "1985 - reocclusion" to "2645 no patient involvement" the evaluation/results/conclusions coding was removed, as they are not applicable.Analysis: the sample was not returned to the user facility because there was not a second lutonix dcb used n the index procedure; therefore, no device evaluation will be performed.A lot history review or a review of the device history record (dhr) were not conducted because a second lutonix device was not used during the index procedure.Conclusion: the actual sample was not returned for evaluation because only one lutonix dcb was used and it is captured in manufacturers report number 3006513822-2017-0002.If additional information becomes known to the manufacturer, a supplemental report will be provided will all relevant information.Only one lutonix dcb used in procedure, captured in manufacturers report number 3006513822-2017-00027.

• 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: 6321865
• Report Number: 3006513822-2017-00028
• Device Sequence Number: 10907201
• Product Code: ONU
• UDI-Device Identifier: 00801741088568
• UDI-Public: (01)00801741088568(17)170122(10)GFZA2257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2017
• Device Model Number: 9004
• Device Catalogue Number: UNK SFA 035
• Device Lot Number: GFZA2257
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 04/23/2019
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 06/18/2017; 05/03/2019
• 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: 58 YR
• Patient Weight: 64