MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

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

Patient Problems Cardiac Arrest (1762); Death (1802); Reocclusion (1985); Thrombosis (2100); Lymphoma (3263)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Age at event: mean age.Sex: majority gender.Date of event: estimate based on date of article publication cardiovasc intervent radiol (2018) 41:882¿889 https://doi.Org/10.1007/s00270-018-1942-z.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to evaluate the effect of percutaneous transluminal angioplasty (pta) on haemodialysis fistulas utilising drug-coated balloons with plain balloon vessel preparation (dcb).Thirty-one consecutive patients on chronic haemodialysis therapy were included in the study group and were treated with dcb.Owing to a limited number of patients, the control group represented patients treated at the institution between 2006 and 2011 with pta.In the control group, the last 31 consecutive patients treated in this period were included.A seldinger technique with a retrograde venous puncture was used.Vascular access was secured with a non-medtronic 0.035-in.Stiff hydrophilic guidewire and a 6 french sheath, and a digital subtraction angiography was performed.In the control group, standard pta balloon catheters including admiral xtreme balloon and reef hp balloon catheters with nominal pressures between 6 and 22 bar were used.In the control group, after achieving haemodynamic success (less than 30% residual stenosis), the procedure was finished.In the study group, standard pta balloon catheters were used first for vessel preparation in the same manner as plain balloons in the control group.After achieving a haemodynamic success, drug-coated balloons including the in.Pact admiral balloon catheters were used according to the manufacturer protocol, for drug administration.After the procedure, control fistulography was performed in two orthogonal planes, to evaluate the results and to exclude any other concurrent stenosis.All patients completed 6-month follow-up.There was one death reported at 12 months to cardiac arrest.Three deaths reported at 24 months (two patients had cardiac arrest and one died because of lymphoma) in the dcb group, one patient had kidney transplantation, and one patient ended up in surgery (for new fistula creation), because of avf thrombosis.In the pta group, two patients were dead at 24-month follow-up.Both died because of a cardiac arrest.Two more patients had avf thrombosis and underwent surgery.None of these events were suspected to be related to dcb.The target lesion primary patency at 6 months was significantly higher in the dcb group 90.3% vs 61.3% in the pta group mean primary patency in the dcb group was 534.2 days.In the dcb group, 18 procedures were performed.In comparison, 40 procedures were performed in the pta group.Twelve patients in the dcb group were treated twice or more during the follow-up.In the pta group, 25 patients were treated twice or more.The results of our study indicate that dcb could be a promising approach to the clinical problem of avf dysfunction, especially in decreasing the rate of reinterventions.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7693806
• MDR Text Key: 114173930
• Report Number: 9612164-2018-01775
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• 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: 65 YR