MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Restenosis (4576)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through results of clinical trial that three months and eighteen days post index procedure using drug-coated balloon catheter, subject had adverse event stenosis which required additional surgical intervention.It was further reported that five months seven days post index procedure, patient reportedly experienced restenosis.The target lesion had initial stenosis of ninety percent.Treatment re-intervention was successful, and the patient recovered with residual stenosis of five percent.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 02/2023.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 02/2023), g3, h6 (method) 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.H3 other text : device not returned.
Event or Problem Description
It was reported through results of clinical trial that three months and eighteen days post index procedure using drug-coated balloon catheter, subject had adverse event stenosis of cephalic arch vein which required additional surgical intervention.It was further reported that five months seven days post index procedure, subject had adverse event stenosis of cephalic arch vein which required additional surgical intervention.Reportedly, the patient experienced restenosis.The target lesion had initial maximum stenosis of ninety percent.Treatment re-intervention was successful, and the patient recovered with final residual stenosis of five percent.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2023), g3, h6 (patient).H11: b5.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 or Problem Description
It was reported through the results of clinical trial that three months and eighteen days post index procedure using drug-coated balloon catheter in cephalic vein, subject had an adverse event stenosis of cephalic arch vein which required an arteriovenous access circuit reintervention.It was further reported that five months and seven days post index procedure, subject had an adverse event stenosis of cephalic arch vein which required an arteriovenous access circuit reintervention.It was also reported that eight months and seven days post index procedure, subject had an adverse event malfunctioning fistula due to elevated venous pressures which required an arteriovenous access circuit reintervention.Furthermore, one year and twenty days post index procedure, subject developed an adverse event malfunctioning fistula due to prolonged bleeding which required an arteriovenous access circuit reintervention.Reportedly, the patient experienced target lesion restenosis and prolonged bleeding.Standard percutaneous transluminal angioplasty was used for treatment.The re-intervention was successful, and no new access was created.The current status of the patient is unknown.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16239771
• Report Number: 3006513822-2023-00002
• Device Sequence Number: 6523173
• Product Code: PRC
• UDI-Device Identifier: 00801741135484
• UDI-Public: (01)00801741135484
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX3575940V
• Device Lot Number: GFFN1662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 02/20/2023; 09/06/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/24/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White