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	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 7 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 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 unlikely related to the study device or 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 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 mid superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient's vessel containing the target lesion was reportedly reoccluded.A reintervention was performed involving two stents placed in the left mid sfa.The hcp deemed the treatment to be successful.The investigator assessed that the event was unlikely related to the study devices and procedure.The samples were discarded by the user facility and are 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 manufacturer¿s report number is 3006513822-2017-00305.
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 mid superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient's vessel containing the target lesion was reportedly reoccluded.The patient was put on a conservative treatment with no additional intervention at this time.The investigator assessed that the event was not related to the study devices or procedure.The samples were discarded by the user facility and are 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 manufacturer¿s report number is 3006513822-2017-00305.
Additional Manufacturer Narrative
Corrected data: the outcomes attributed to adv ev was changed from "required intervention to prevent permanent impairment/damage (devices)" to "n/a." 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 mid superficial femoral artery (sfa).Approximately 6 months after the index procedure, the patient's vessel containing the target lesion was reportedly reoccluded.A reintervention was performed involving two stents placed in the left mid sfa.The hcp deemed the treatment to be successful.The investigator assessed that the event was unlikely related to the study devices and procedure.The samples were discarded by the user facility and are 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 manufacturer¿s report number is 3006513822-2017-00305." to "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 mid superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient's vessel containing the target lesion was reportedly reoccluded.The patient was put on a conservative treatment with no additional intervention at this time.The investigator assessed that the event was not related to the study devices or procedure.The samples were discarded by the user facility and are 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 manufacturer¿s report number is 3006513822-2017-00305." the eval code and desc section was changed to align with guidance set out by us fda effective on july 6th, 2018.The method codes "3263 and 3317" were changed to "4115, 3331, and 4110." the conclusion code "92" was changed to "4310." conclusion the following sentences were added "the event was originally reported because information reasonably suggested that a serious injury had occurred.Now it has been discovered that the patient was prescribed oral medication and did not have a revascularization procedure, which means that a serious injury has not occurred." the following word "unlikely" was changed to "not." the number "7" was changed to "9" due to two more complaints for reocclusion on this lot number occurring after initial mdr submission.The samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed 9 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 event was originally reported because information reasonably suggested that a serious injury had occurred.Now it has been discovered that the patient was prescribed oral medication and did not have a revascularization procedure, which means that a serious injury has not occurred.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 devices or 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: 7120927
• Report Number: 3006513822-2017-00304
• Device Sequence Number: 1466654
• Product Code: ONU
• UDI-Device Identifier: 00801741088742
• UDI-Public: (01)00801741088742
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/20/2018

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: 08/31/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613400150
• Device Lot Number: GFZH2964
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 09/20/2018
• 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: 77 YR
• Patient Weight: 70