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Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802); Reocclusion (1985); Thrombosis (2100)
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. 12 patients in the dcb group were treated twice or more during th e 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.
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Brand NameREEF
Manufacturer (Section D)
via martiri della liberta', 7
25030 roncadelle,bs
Manufacturer (Section G)
via martiri della liberta', 7
25030 roncadelle,bs
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key7693778
MDR Text Key114174691
Report Number3004066202-2018-00039
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSI
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1