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

Model Number 9010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being 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 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.(expiration date: 09/2022).Device not returned.

Event Description

It was reported through the results of a clinical trial that one day post index procedure using a drug-coated balloon catheter, patient was diagnosed with access thrombosis.It was further reported that four months ten days post index procedure, patient reportedly experienced restenosis and was diagnosed with access thrombosis.However, the treatment re-intervention was successful, and the patient recovered.The current status of the patient is unknown.

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.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided by bd represents all 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 Description

It was reported through the results of a clinical trial that one day post an index procedure completion using a drug-coated balloon catheter in the cephalic vein at cephalic arch, the subject had a serious adverse event of access thrombosis of the cephalic vein due to access thrombosis which required an arteriovenous access circuit re-intervention.Standard percutaneous transluminal balloon angioplasty procedure and angioplasty of inflow segment of cephalic vein was performed to treat the access thrombosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.It was further reported that four months and ten days post an index procedure completion, the subject had a serious adverse event of right upper extremity arteriovenous fistula with clotted access due to access thrombosis which required an arteriovenous access circuit re-intervention.Standard percutaneous transluminal balloon angioplasty procedure and thromboangioplasty with stent at cephalic arch were performed to treat the access thrombosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.It was also reported that nine months and twenty days post an index procedure completion, the subject had an adverse event of elevated venous pressure, low access flow, stenosis in upper arm cephalic vein.Furthermore, one year, four months, and four days post an index procedure completion, the subject had a serious adverse event of access thrombosis of the cephalic vein due to access thrombosis which required an arteriovenous access circuit re-intervention.Standard percutaneous transluminal balloon angioplasty procedure, endovascular thrombectomy with in a new stent within old stent of cephalic arch, and stent graft placement were performed to treat the access thrombosis.Treatment re-intervention was successful, no new access created, and the outcome of the serious adverse event was resolved.Reportedly, there have been no documented device deficiencies and no secondary stage procedures were reported for this subject to date.The current status of the patient is unknown.

• Brand Name: LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 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: 16143427
• MDR Text Key: 307154021
• Report Number: 3006513822-2022-00054
• Device Sequence Number: 1
• Product Code: PRC
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9010
• Device Catalogue Number: LX3575860V
• Device Lot Number: GFFT3104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American