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	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.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: 07/2022.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.Device not returned.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.A definitive root cause could not be determined based upon the available information.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: 07/2022), 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.
Event or Problem Description
It was reported through the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.A definitive root cause could not be determined based upon the available information.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: 07/2022), g3, h6 (patient).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 the results of a clinical trial that approximately one month and ten days post index procedure using a drug-coated balloon catheter, prolonged bleeding due to stenosis of the target lesion occurred and was successfully treated.It was further reported that approximately eleven months and eight days post index procedure, restenosis of target lesion occurred and was successfully treated.The re-intervention was successful, and the outcome was recovered.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.A definitive root cause could not be determined based upon the available information.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: 07/2022).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 a clinical trial that one month and thirteen days post an index procedure completion using a drug-coated balloon catheter in the basilic vein via the left upper arm, the subject had an adverse event of prolonged bleeding due to stenosis in basilic vein which required an arteriovenous access circuit reintervention.Reportedly, standard percutaneous transluminal balloon angioplasty and drug-coated balloon angioplasty procedures were performed to treat prolonged bleeding.The reintervention was successful, and the outcome of serious adverse event was resolved.It was further reported that seven months and eleven days after index procedure, the subject had an adverse event of recurrent prolonged bleeding due to stenosis in basilic vein.Reportedly, standard percutaneous transluminal balloon angioplasty and drug-coated balloon angioplasty procedures were performed to treat prolonged bleeding.The reintervention was successful, and the outcome of serious adverse event was resolved.It was also reported that eleven months and eight days after index procedure, the subject had an adverse event of stenosis on target limb and appearances of new lesions in basilic vein due to decreased access blood flow.Reportedly, standard percutaneous transluminal balloon angioplasty and drug-coated balloon angioplasty procedures were performed to treat decreased access blood flow.The reintervention was successful, and the outcome of serious adverse event was resolved.Furthermore, one year, two months, and twenty-two days after index procedure, the subject had an adverse event of left brachiobasilic fistula with pre-axillary venous stenosis due to prolonged bleeding.Reportedly, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.The reintervention was successful, and the outcome of serious adverse event was resolved.In addition, one year, three months, and twenty-one days after index procedure, the subject had an adverse event of recurrent stenosis on target limb left basilic vein due to prolonged bleeding.Reportedly, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.The reintervention was successful, and the outcome of the serious adverse event was resolved.Evidently, two years, one month, and eighteen days after index procedure, the subject had an adverse event of recurrent stenosis located in basilic vein due to prolonged bleeding.Reportedly, standard percutaneous transluminal balloon angioplasty procedure was performed to treat prolonged bleeding.The reintervention was successful, and the outcome of the serious adverse event was resolved.There have been no documented device deficiencies or secondary stage procedures reported for this subject to date.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: 15370200
• Report Number: 3006513822-2022-00027
• Device Sequence Number: 1726409
• Product Code: PRC
• UDI-Device Identifier: 00801741135453
• UDI-Public: (01)00801741135453
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 05/24/2024

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: LX3575840V
• Device Lot Number: GFEU2004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 04/12/2023; 05/28/2024
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 01/04/2023; 04/17/2023; 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian