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

Model Number 9004

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review 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.

Event Description

It was reported that post procedure involving a drug coated balloon, a pseudo-aneurysm allegedly developed at the treatment site.It was reported that the pseudo-aneurysm was treated with additional angioplasty and thrombin injections.The health care provider reportedly believed that the pseudo-aneurysm was caused by the drug coated balloon.The status of the patient is unknown.

Manufacturer Narrative

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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the sample was discarded by the user facility; therefore, a device evaluation cannot be performed.It is known the patient developed a pseudoaneurysm at the treatment site after treatment with the lutonix dcb.It was reported that the physician did an additional angioplasty and thrombin injections to eliminate the pseudoanuerysm.The physician determined the lutonix dcb caused the pseudoanuerysm.The patient status is unknown after the completion of the procedure.However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s).Labeling review: ifu dw5159-01 in section 8 states potential adverse events which may be associated with a peripheral balloon dilatation procedure includes: psuedoanuerysm.In section 9.0 physician counseling information states physicians should consider the following in counseling patients about this product: discuss the risks associated with a pta procedure, discuss the risks associated with a paclitaxel coated pta catheter, discuss the risks/benefits issues.

Event Description

It was reported that post procedure involving a drug coated balloon, a pseudo-aneurysm allegedly developed at the treatment site.It was reported that the pseudo-aneurysm was treated with additional angioplasty and thrombin injections.The health care provider reportedly believed that the pseudo-aneurysm was caused by the drug coated balloon.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was discarded by the user facility; therefore, a device evaluation cannot be performed.The physician stated the pseudoanuerysm is possibly due to aggressive inflation with a balloon greater than the predicted vessel diameter.It was reported that the physician prepared the lutonix dcb per the ifu.The hcp inflated the lutonix dcb for 180 seconds between nominal pressure and rbp.It is known the patient developed a pseudoanuerysm at the treatment site, stenotic composite left iliac-popliteal vein graft, after treatment with the lutonix dcb.The lutonix 035 dcb is not intended for use in stenotic composite vein grafts.The physician performed an additional angioplasty and thrombin injections to eliminate the pseudoanuerysm.Approximately three weeks later, the patient had an interposition vein graft.However, the lack of further information or the returned sample prevents identification of a root cause(s).Labeling review: labeling review results: ifu dw5159-01 in section 8 states potential adverse events which may be associated with a peripheral balloon dilatation procedure includes: psuedoanuerysm.In section 9.0 physician counseling information states physicians should consider the following in counseling patients about this product: discuss the risks associated with a pta procedure.Discuss the risks associated with a paclitaxel coated pta catheter.Discuss the risks/benefits issues.In section 2.0 indications for use states.The lutonix® 035 drug coated balloon pta catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions up to 300mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7mm.In section 4.0 warnings states.Do not exceed the rated burst pressure (rbp)recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over-pressurization, use of a pressure monitoring device is recommended.In section 12.6 use of lutonix catheter states 5.To ensure therapeutic drug delivery, the lutonix® catheter should be advanced to the target site in the shortest possible time (i.E.~30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio = 1:1).If the time to deployment of the lutonix® catheter exceeds 3 minutes, the catheter requires replacement with a new unit.H11: b5, h6 (conclusion).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 Description

It was reported that post procedure involving a drug coated balloon in a iliac-popliteal vein graft, a pseudo-aneurysm allegedly developed at the treatment site.It was reported that the pseudo-aneurysm was treated with additional angioplasty and thrombin injections.The health care provider reportedly believed that the pseudo-aneurysm was caused by the drug coated balloon.The patient would require an interposition vein graft 3 weeks later.The patient reportedly has a patent graft.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Type of Device: DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9158818
• MDR Text Key: 164120983
• Report Number: 3006513822-2019-00123
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

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
• Device Operator: Other
• Device Expiration Date: 12/02/2021
• Device Model Number: 9004
• Device Catalogue Number: 9090475700040
• Device Lot Number: GFCZ0295
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/07/2019; 12/23/2019
• Supplement Dates FDA Received: 10/22/2019; 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention